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    Clinical Trial Results:
    A randomised, double-blind, placebo-controlled, parallel-group, dose-range trial to investigate the efficacy and safety of FE 999302 as add-on treatment to follitropin delta (REKOVELLE) in women undergoing controlled ovarian stimulation in a long GnRH agonist protocol

    Summary
    EudraCT number
    		 2017-003810-13
    Trial protocol
    		 CZ   DK   BE   GB   ES  
    Global end of trial date

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Jan 2021
    First version publication date
    07 Jan 2021
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    000289
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03564509
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Ferring Pharmaceuticals A/S
    Sponsor organisation address
    International PharmaScience Center, Kay Fiskers Plads 11, Copenhagen S, Denmark, 2300
    Public contact
    Global Clinical Compliance, Ferring Pharmaceuticals, DK0-Disclosure@ferring.com
    Scientific contact
    Global Clinical Compliance, Ferring Pharmaceuticals, DK0-Disclosure@ferring.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Interim
    Date of interim/final analysis
    30 Jan 2020
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    21 Oct 2019
    Global end of trial reached?
    No
    General information about the trial
    Main objective of the trial
    To investigate the effects of FE 999302 on parameters influencing pregnancy rates in women undergoing Controlled Ovarian Stimulation (COS) with follitropin delta in a long gonadotropin releasing hormone (GnRH) agonist protocol.
    Protection of trial subjects
    The trial was performed in accordance with the version of Declaration of Helsinki in force at the initiation of the trial. The trial was performed in compliance with International Council for Harmonisation Good Clinical Practice (ICH GCP).
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    14 May 2018
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United Kingdom: 60
    Country: Number of subjects enrolled
    Spain: 297
    Country: Number of subjects enrolled
    Belgium: 34
    Country: Number of subjects enrolled
    Czechia: 170
    Country: Number of subjects enrolled
    Denmark: 59
    Worldwide total number of subjects
    620
    EEA total number of subjects
    620
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    620
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The trial was performed in 5 countries, and a total of 20 sites randomised subjects to the trial (2 in Belgium, 4 in Czech Republic, 4 in Denmark, 6 in Spain, and 4 in United Kingdom) between May 2018 to Jan 2020.

    Pre-assignment
    Screening details
    		 In total, 773 subjects were screened of which 620 subjects were randomised. Of the randomised subjects, 619 subjects were exposed to investigational medicinal product (IMP): 515 to FE 999302 and 104 to placebo. The number of subjects exposed to each of the dose levels were: 104, 101, 99, 107, and 104 to 1, 2, 4, 8, and 12 μg, respectively.

    Period 1
    Period 1 title
    Randomised Treatment Period (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    FE 999302 and placebo were identical in appearance and the trial was considered double-blind as neither the subject nor the investigator knew whether the subject was receiving FE 999302 or placebo.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 FE 999302 (1 μg) and Follitropin Delta
    Arm description
    		 Dose 1 μg of FE 999302, a recombinant human choriogonadotropin (rhCG) solution for subcutaneous injection; individualised follitropin delta dose
    Arm type
    		 Experimental and add-on treatment

    Investigational medicinal product name
    FE 999302 (1 μg)
    Investigational medicinal product code
    FE 999302
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Dose 1 μg of FE 999302, a rhCG solution for subcutaneous injection; individualised follitropin delta dose

    Arm title
    		 FE 999302 (2 μg) and Follitropin Delta
    Arm description
    		 Dose 2 μg of FE 999302, a rhCG solution for subcutaneous injection; individualised follitropin delta dose
    Arm type
    		 Experimental and add-on treatment

    Investigational medicinal product name
    FE 999302 (2 μg)
    Investigational medicinal product code
    FE 999302
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Dose 2 μg of FE 999302, a rhCG solution for subcutaneous injection; individualised follitropin delta dose

    Arm title
    		 FE 999302 (4 μg) and Follitropin Delta
    Arm description
    		 Dose 4 μg of FE 999302, a rhCG solution for subcutaneous injection; individualised follitropin delta dose
    Arm type
    		 Experimental and add-on treatment

    Investigational medicinal product name
    FE 999302 (4 μg)
    Investigational medicinal product code
    FE 999302
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Dose 4 μg of FE 999302, a rhCG solution for subcutaneous injection; individualised follitropin delta dose

    Arm title
    		 FE 999302 (8 μg) and Follitropin Delta
    Arm description
    		 Dose 8 μg of FE 999302, a rhCG solution for subcutaneous injection; individualised follitropin delta dose
    Arm type
    		 Experimental and add-on treatment

    Investigational medicinal product name
    FE 999302 (8 μg)
    Investigational medicinal product code
    FE 999302
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Dose 8 μg of FE 999302, a rhCG solution for subcutaneous injection; individualised follitropin delta dose

    Arm title
    		 FE 999302 (12 μg) and Follitropin Delta
    Arm description
    		 Dose 12 μg of FE 999302, a rhCG solution for subcutaneous injection; individualised follitropin delta dose
    Arm type
    		 Experimental and add-on treatment

    Investigational medicinal product name
    FE 999302 (12 μg)
    Investigational medicinal product code
    FE 999302
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Dose 12 μg of FE 999302, a rhCG solution for subcutaneous injection; individualised follitropin delta dose

    Arm title
    		 Placebo and Follitropin Delta
    Arm description
    		 Placebo and individualised follitropin delta dose
    Arm type
    		 Placebo and add-on treatment

    Investigational medicinal product name
    Placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Placebo and individualised follitropin delta dose

    Number of subjects in period 1 [1]
    		FE 999302 (1 μg) and Follitropin Delta FE 999302 (2 μg) and Follitropin Delta FE 999302 (4 μg) and Follitropin Delta FE 999302 (8 μg) and Follitropin Delta FE 999302 (12 μg) and Follitropin Delta Placebo and Follitropin Delta
    Started
    104
    101
    99
    107
    104
    104
    Completed
    101
    99
    94
    99
    100
    98
    Not completed
    3
    2
    5
    8
    4
    6
         Consent withdrawn by subject
    -
    1
    1
    -
    -
    -
         Adverse event, non-fatal
    1
    1
    3
    7
    4
    5
         Other
    1
    -
    1
    -
    -
    -
         Lost to follow-up
    1
    -
    -
    1
    -
    1
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: In total, 773 subjects were screened. Of these, 153 were screening failures and 620 were randomised. Of the 620 randomised subjects, 619 subjects were exposed to IMP. The subject that was not exposed to IMP fulfilled exclusion criterion 6 (abnormal karyotype) and should not have been randomised.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    FE 999302 (1 μg) and Follitropin Delta
    Reporting group description
    		 Dose 1 μg of FE 999302, a recombinant human choriogonadotropin (rhCG) solution for subcutaneous injection; individualised follitropin delta dose

    Reporting group title
    FE 999302 (2 μg) and Follitropin Delta
    Reporting group description
    		 Dose 2 μg of FE 999302, a rhCG solution for subcutaneous injection; individualised follitropin delta dose

    Reporting group title
    FE 999302 (4 μg) and Follitropin Delta
    Reporting group description
    		 Dose 4 μg of FE 999302, a rhCG solution for subcutaneous injection; individualised follitropin delta dose

    Reporting group title
    FE 999302 (8 μg) and Follitropin Delta
    Reporting group description
    		 Dose 8 μg of FE 999302, a rhCG solution for subcutaneous injection; individualised follitropin delta dose

    Reporting group title
    FE 999302 (12 μg) and Follitropin Delta
    Reporting group description
    		 Dose 12 μg of FE 999302, a rhCG solution for subcutaneous injection; individualised follitropin delta dose

    Reporting group title
    Placebo and Follitropin Delta
    Reporting group description
    		 Placebo and individualised follitropin delta dose

    Reporting group values
    		 FE 999302 (1 μg) and Follitropin Delta FE 999302 (2 μg) and Follitropin Delta FE 999302 (4 μg) and Follitropin Delta FE 999302 (8 μg) and Follitropin Delta FE 999302 (12 μg) and Follitropin Delta Placebo and Follitropin Delta Total
    Number of subjects
    		 104 101 99 107 104 104 619
    Age categorical
    Units: Subjects
        30-37 years
    		 73 71 68 71 71 72 426
        38-42 years
    		 31 30 31 36 33 32 193
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 35.6 ( 3.3 ) 35.6 ( 3.4 ) 35.5 ( 3.2 ) 35.7 ( 3.5 ) 35.3 ( 3.5 ) 35.6 ( 3.2 ) -
    Gender categorical
    Units: Subjects
        Female
    		 104 101 99 107 104 104 619
        Male
    		 0 0 0 0 0 0 0
    Race
    Units: Subjects
        American Indian or Alaska Native
    		 1 0 0 0 0 2 3
        Asian
    		 2 2 3 2 2 2 13
        Black or African American
    		 0 2 0 0 2 0 4
        Multiple
    		 0 0 0 1 0 0 1
        White
    		 101 97 96 104 100 100 598
    Ethnicity
    Units: Subjects
        Hispanic or Latino
    		 2 5 1 0 1 2 11
        Not Hispanic or Latino
    		 102 96 98 107 103 102 608
    Body mass index (BMI)
    Units: kg/m^2
        arithmetic mean (standard deviation)
    		 24.1 ( 3.5 ) 23.6 ( 3.3 ) 23.7 ( 3.7 ) 24.5 ( 3.8 ) 24.2 ( 3.8 ) 23.6 ( 3.1 ) -

    End points

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    End points reporting groups
    Reporting group title
    FE 999302 (1 μg) and Follitropin Delta
    Reporting group description
    		 Dose 1 μg of FE 999302, a recombinant human choriogonadotropin (rhCG) solution for subcutaneous injection; individualised follitropin delta dose

    Reporting group title
    FE 999302 (2 μg) and Follitropin Delta
    Reporting group description
    		 Dose 2 μg of FE 999302, a rhCG solution for subcutaneous injection; individualised follitropin delta dose

    Reporting group title
    FE 999302 (4 μg) and Follitropin Delta
    Reporting group description
    		 Dose 4 μg of FE 999302, a rhCG solution for subcutaneous injection; individualised follitropin delta dose

    Reporting group title
    FE 999302 (8 μg) and Follitropin Delta
    Reporting group description
    		 Dose 8 μg of FE 999302, a rhCG solution for subcutaneous injection; individualised follitropin delta dose

    Reporting group title
    FE 999302 (12 μg) and Follitropin Delta
    Reporting group description
    		 Dose 12 μg of FE 999302, a rhCG solution for subcutaneous injection; individualised follitropin delta dose

    Reporting group title
    Placebo and Follitropin Delta
    Reporting group description
    		 Placebo and individualised follitropin delta dose

    Primary: Number of good-quality blastocysts on day 5 after oocyte retrieval (grade 3BB or higher)

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    End point title
    		 Number of good-quality blastocysts on day 5 after oocyte retrieval (grade 3BB or higher)
    End point description
    Quality of blastocysts was assessed by blastocyst expansion and hatching status, blastocyst inner cell mass grading, and trophectoderm grading. The scoring was based on the classification system by Gardner and Schoolcraft, with additional categories for inner cell mass (degenerative or no inner cell mass) and trophectoderm (degenerative or very large cells). The analysis population included the full analysis set (FAS) which consisted of all subjects who were randomised and started treatment with FE 999302 or placebo. Subjects were analysed according to the treatment they actually received.
    End point type
    Primary
    End point timeframe
    On day 5 after oocyte retrieval
    End point values
    		 FE 999302 (1 μg) and Follitropin Delta FE 999302 (2 μg) and Follitropin Delta FE 999302 (4 μg) and Follitropin Delta FE 999302 (8 μg) and Follitropin Delta FE 999302 (12 μg) and Follitropin Delta Placebo and Follitropin Delta
    Number of subjects analysed
    104
    101
    99
    107
    104
    104
    Units: Number of blastocysts
        arithmetic mean (standard deviation)
    2.3 ( 2.1 )
    3.0 ( 2.8 )
    2.3 ( 2.5 )
    2.6 ( 2.5 )
    2.2 ( 2.4 )
    3.3 ( 2.9 )
    Statistical analysis title
    		 FE 999302, Placebo
    Comparison groups
    FE 999302 (1 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 0.0012
    Method
    		 Negative binomial regression model
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.65
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.5
         upper limit
    		 0.85
    Notes
    [1] - Treatment groups were compared using a negative binomial regression model with treatment, age strata, and anti-Müllerian hormone (AMH) group as factors.
    Statistical analysis title
    		 FE 999302, Placebo
    Comparison groups
    FE 999302 (2 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    205
    Analysis specification
    Pre-specified
    Analysis type
    		 other [2]
    P-value
    		 = 0.3822
    Method
    		 Negative binomial regression model
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.89
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.69
         upper limit
    		 1.15
    Notes
    [2] - Treatment groups were compared using a negative binomial regression model with treatment, age strata, and AMH group as factors.
    Statistical analysis title
    		 FE 999302, Placebo
    Comparison groups
    FE 999302 (4 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [3]
    P-value
    		 = 0.0021
    Method
    		 Negative binomial regression model
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.66
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.51
         upper limit
    		 0.86
    Notes
    [3] - Treatment groups were compared using a negative binomial regression model with treatment, age strata, and AMH group as factors.
    Statistical analysis title
    		 FE 999302, Placebo
    Comparison groups
    FE 999302 (8 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    211
    Analysis specification
    Pre-specified
    Analysis type
    		 other [4]
    P-value
    		 = 0.0491
    Method
    		 Negative binomial regression model
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.78
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 1
    Notes
    [4] - Treatment groups were compared using a negative binomial regression model with treatment, age strata, and AMH group as factors.
    Statistical analysis title
    		 FE 999302, Placebo
    Comparison groups
    FE 999302 (12 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [5]
    P-value
    		 = 0.0005
    Method
    		 Negative binomial regression model
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.63
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.48
         upper limit
    		 0.82
    Notes
    [5] - Treatment groups were compared using a negative binomial regression model with treatment, age strata, and AMH group as factors.

    Secondary: Number and quality of embryos on day 3 after oocyte retrieval

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    End point title
    		 Number and quality of embryos on day 3 after oocyte retrieval
    End point description
    Number of embryos (total and good-quality) on Day 3. A good-quality embryo was defined as an embryo with ≥6 cells and ≤25% fragmentation, or with embryo stage classified as compacting/compacted. The analysis population included the FAS which consisted of all subjects who were randomised and started treatment with FE 999302 or placebo. Subjects were analysed according to the treatment they actually received.
    End point type
    Secondary
    End point timeframe
    On day 3 after oocyte retrieval
    End point values
    		 FE 999302 (1 μg) and Follitropin Delta FE 999302 (2 μg) and Follitropin Delta FE 999302 (4 μg) and Follitropin Delta FE 999302 (8 μg) and Follitropin Delta FE 999302 (12 μg) and Follitropin Delta Placebo and Follitropin Delta
    Number of subjects analysed
    104
    101
    99
    107
    104
    104
    Units: Number of embryos
    arithmetic mean (standard deviation)
        Number of embryos
    6.1 ( 3.6 )
    6.2 ( 3.9 )
    5.7 ( 3.7 )
    6.0 ( 3.6 )
    5.2 ( 3.7 )
    7.4 ( 4.2 )
        Number of good-quality embryos
    4.9 ( 3.2 )
    5.2 ( 3.5 )
    4.4 ( 3.3 )
    4.9 ( 3.1 )
    4.3 ( 3.5 )
    6.0 ( 3.7 )
    Statistical analysis title
    		 FE 999302, Placebo
    Statistical analysis description
    Treatment comparison: Number of embryos
    Comparison groups
    FE 999302 (1 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [6]
    P-value
    		 = 0.007
    Method
    		 Negative binomial regression model
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.68
         upper limit
    		 0.94
    Notes
    [6] - Treatment groups were compared using a negative binomial regression model with treatment, age strata, and AMH group as factors.
    Statistical analysis title
    		 FE 999302, Placebo
    Statistical analysis description
    Treatment comparison: Number of embryos
    Comparison groups
    Placebo and Follitropin Delta v FE 999302 (2 μg) and Follitropin Delta
    Number of subjects included in analysis
    205
    Analysis specification
    Pre-specified
    Analysis type
    		 other [7]
    P-value
    		 = 0.0183
    Method
    		 Negative binomial regression model
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 0.97
    Notes
    [7] - Treatment groups were compared using a negative binomial regression model with treatment, age strata, and AMH group as factors.
    Statistical analysis title
    		 FE 999302, Placebo
    Statistical analysis description
    Treatment comparison: Number of embryos
    Comparison groups
    FE 999302 (4 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [8]
    P-value
    		 = 0.0005
    Method
    		 Negative binomial regression model
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.63
         upper limit
    		 0.88
    Notes
    [8] - Treatment groups were compared using a negative binomial regression model with treatment, age strata, and AMH group as factors.
    Statistical analysis title
    		 FE 999302, Placebo
    Statistical analysis description
    Treatment comparison: Number of embryos
    Comparison groups
    FE 999302 (8 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    211
    Analysis specification
    Pre-specified
    Analysis type
    		 other [9]
    P-value
    		 = 0.0069
    Method
    		 Negative binomial regression model
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.68
         upper limit
    		 0.94
    Notes
    [9] - Treatment groups were compared using a negative binomial regression model with treatment, age strata, and AMH group as factors.
    Statistical analysis title
    		 FE 999302, Placebo
    Statistical analysis description
    Treatment comparison: Number of embryos
    Comparison groups
    FE 999302 (12 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [10]
    P-value
    		 < 0.0001
    Method
    		 Negative binomial regression model
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.69
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.58
         upper limit
    		 0.81
    Notes
    [10] - Treatment groups were compared using a negative binomial regression model with treatment, age strata, and AMH group as factors.
    Statistical analysis title
    		 FE 999302, Placebo
    Statistical analysis description
    Treatment comparison: Number of good-quality embryos
    Comparison groups
    FE 999302 (1 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [11]
    P-value
    		 = 0.0055
    Method
    		 Negative binomial regression model
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.78
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.65
         upper limit
    		 0.93
    Notes
    [11] - Treatment groups were compared using a negative binomial regression model with treatment, age strata, and AMH group as factors.
    Statistical analysis title
    		 FE 999302, Placebo
    Statistical analysis description
    Treatment comparison: Number of good-quality embryos
    Comparison groups
    FE 999302 (2 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    205
    Analysis specification
    Pre-specified
    Analysis type
    		 other [12]
    P-value
    		 = 0.0593
    Method
    		 Negative binomial regression model
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 1.01
    Notes
    [12] - Treatment groups were compared using a negative binomial regression model with treatment, age strata, and AMH group as factors.
    Statistical analysis title
    		 FE 999302, Placebo
    Statistical analysis description
    Treatment comparison: Number of good-quality embryos
    Comparison groups
    FE 999302 (4 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [13]
    P-value
    		 = 0.0002
    Method
    		 Negative binomial regression model
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.59
         upper limit
    		 0.85
    Notes
    [13] - Treatment groups were compared using a negative binomial regression model with treatment, age strata, and AMH group as factors.
    Statistical analysis title
    		 FE 999302, Placebo
    Statistical analysis description
    Treatment comparison: Number of good-quality embryos
    Comparison groups
    FE 999302 (8 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    211
    Analysis specification
    Pre-specified
    Analysis type
    		 other [14]
    P-value
    		 = 0.0096
    Method
    		 Negative binomial regression model
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.66
         upper limit
    		 0.94
    Notes
    [14] - Treatment groups were compared using a negative binomial regression model with treatment, age strata, and AMH group as factors.
    Statistical analysis title
    		 FE 999302, Placebo
    Statistical analysis description
    Treatment comparison: Number of good-quality embryos
    Comparison groups
    FE 999302 (12 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [15]
    P-value
    		 < 0.0001
    Method
    		 Negative binomial regression model
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.68
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.57
         upper limit
    		 0.82
    Notes
    [15] - Treatment groups were compared using a negative binomial regression model with treatment, age strata, and AMH group as factors.

    Secondary: Number and quality of blastocysts on day 5 after oocyte retrieval

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    End point title
    		 Number and quality of blastocysts on day 5 after oocyte retrieval
    End point description
    Number of blastocysts (total and good-quality) on Day 5. Blastocyst quality was assessed by blastocyst expansion and hatching status, blastocyst inner cell mass grading, and trophectoderm grading. The scoring was based on the classification system by Gardner and Schoolcraft, with additional categories for inner cell mass (degenerative or no inner cell mass) and trophectoderm (degenerative or very large cells). The analysis population included the FAS which consisted of all subjects who were randomised and started treatment with FE 999302 or placebo. Subjects were analysed according to the treatment they actually received.
    End point type
    Secondary
    End point timeframe
    On day 5 after oocyte retrieval
    End point values
    		 FE 999302 (1 μg) and Follitropin Delta FE 999302 (2 μg) and Follitropin Delta FE 999302 (4 μg) and Follitropin Delta FE 999302 (8 μg) and Follitropin Delta FE 999302 (12 μg) and Follitropin Delta Placebo and Follitropin Delta
    Number of subjects analysed
    104
    101
    99
    107
    104
    104
    Units: Number of blastocysts
        arithmetic mean (standard deviation)
    4.1 ( 3.0 )
    4.7 ( 3.5 )
    3.8 ( 3.0 )
    4.3 ( 3.4 )
    3.6 ( 3.3 )
    5.3 ( 3.8 )
    Statistical analysis title
    		 FE 999302, Placebo
    Comparison groups
    FE 999302 (1 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [16]
    P-value
    		 = 0.0068
    Method
    		 Negative binomial regression model
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.61
         upper limit
    		 0.92
    Notes
    [16] - Treatment groups were compared using a negative binomial regression model with treatment, age strata, and AMH group as factors.
    Statistical analysis title
    		 FE 999302, Placebo
    Comparison groups
    FE 999302 (2 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    205
    Analysis specification
    Pre-specified
    Analysis type
    		 other [17]
    P-value
    		 = 0.1553
    Method
    		 Negative binomial regression model
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 1.06
    Notes
    [17] - Treatment groups were compared using a negative binomial regression model with treatment, age strata, and AMH group as factors.
    Statistical analysis title
    		 FE 999302, Placebo
    Comparison groups
    FE 999302 (4 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [18]
    P-value
    		 = 0.0005
    Method
    		 Negative binomial regression model
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.68
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.55
         upper limit
    		 0.85
    Notes
    [18] - Treatment groups were compared using a negative binomial regression model with treatment, age strata, and AMH group as factors.
    Statistical analysis title
    		 FE 999302, Placebo
    Comparison groups
    FE 999302 (8 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    211
    Analysis specification
    Pre-specified
    Analysis type
    		 other [19]
    P-value
    		 = 0.0235
    Method
    		 Negative binomial regression model
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.64
         upper limit
    		 0.97
    Notes
    [19] - Treatment groups were compared using a negative binomial regression model with treatment, age strata, and AMH group as factors.
    Statistical analysis title
    		 FE 999302, Placebo
    Comparison groups
    FE 999302 (12 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [20]
    P-value
    		 < 0.0001
    Method
    		 Negative binomial regression model
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.65
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.53
         upper limit
    		 0.81
    Notes
    [20] - Treatment groups were compared using a negative binomial regression model with treatment, age strata, and AMH group as factors.

    Secondary: Changes in serum hormone (progesterone) levels from stimulation Day 1 to stimulation Day 6, stimulation Day 8, end-of-stimulation, and oocyte retrieval

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    End point title
    		 Changes in serum hormone (progesterone) levels from stimulation Day 1 to stimulation Day 6, stimulation Day 8, end-of-stimulation, and oocyte retrieval
    End point description
    Blood samples for analysis of serum hormone levels were drawn at stimulation Day 1, stimulation Day 6, stimulation Day 8, end-of-stimulation, and at oocyte retrieval. The analysis population included the FAS which consisted of all subjects who were randomised and started treatment with FE 999302 or placebo. Subjects were analysed according to the treatment they actually received. Timeframe: FE 999302 (1 µg), FE 999302 (2 µg), FE 999302 (4 µg), FE 999302 (8 µg), FE 999302 (12 µg), Placebo Stimulation day 6: n=104, n=99, n=97, n=105, n=104, n=103 Stimulation day 8: n=102, n=97, n=95, n=103, n=100, n=100 End-of-stimulation: n=104, n=99, n=99, n=104, n=103, n=102 Oocyte retrieval: n=103, n=100, n=98, n=106, n=102, n=101
    End point type
    Secondary
    End point timeframe
    Stimulation Day 1 (baseline), Stimulation Day 6, stimulation Day 8, end-of-stimulation (up to 20 stimulation days), and oocyte retrieval
    End point values
    		 FE 999302 (1 μg) and Follitropin Delta FE 999302 (2 μg) and Follitropin Delta FE 999302 (4 μg) and Follitropin Delta FE 999302 (8 μg) and Follitropin Delta FE 999302 (12 μg) and Follitropin Delta Placebo and Follitropin Delta
    Number of subjects analysed
    104
    101
    99
    107
    104
    104
    Units: nmol/L
    arithmetic mean (standard deviation)
        Stimulation Day 6
    0.094 ( 0.486 )
    0.050 ( 0.320 )
    0.306 ( 2.454 )
    0.187 ( 0.361 )
    0.268 ( 0.450 )
    -0.215 ( 2.691 )
        Stimulation Day 8
    0.599 ( 2.887 )
    0.317 ( 0.407 )
    0.377 ( 0.562 )
    0.620 ( 0.702 )
    0.691 ( 0.638 )
    0.022 ( 2.734 )
        End-of-stimulation visit
    1.327 ( 1.001 )
    1.429 ( 0.984 )
    1.687 ( 1.636 )
    2.407 ( 1.608 )
    2.555 ( 1.571 )
    1.090 ( 2.797 )
        Oocyte retrieval visit
    28.304 ( 16.381 )
    26.426 ( 15.671 )
    23.680 ( 16.108 )
    23.666 ( 12.553 )
    21.818 ( 10.590 )
    31.154 ( 16.586 )
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 6)
    Comparison groups
    FE 999302 (1 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [21]
    P-value
    		 = 0.4287
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 1.3
    Notes
    [21] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 6)
    Comparison groups
    FE 999302 (2 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    205
    Analysis specification
    Pre-specified
    Analysis type
    		 other [22]
    P-value
    		 = 0.4301
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.89
         upper limit
    		 1.3
    Notes
    [22] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 6)
    Comparison groups
    FE 999302 (4 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [23]
    P-value
    		 = 0.1019
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.97
         upper limit
    		 1.41
    Notes
    [23] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 6)
    Comparison groups
    FE 999302 (8 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    211
    Analysis specification
    Pre-specified
    Analysis type
    		 other [24]
    P-value
    		 = 0.0046
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.09
         upper limit
    		 1.57
    Notes
    [24] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 6)
    Comparison groups
    FE 999302 (12 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [25]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.54
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.28
         upper limit
    		 1.85
    Notes
    [25] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 8)
    Comparison groups
    FE 999302 (1 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [26]
    P-value
    		 = 0.8375
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.83
         upper limit
    		 1.25
    Notes
    [26] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 8)
    Comparison groups
    FE 999302 (2 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    205
    Analysis specification
    Pre-specified
    Analysis type
    		 other [27]
    P-value
    		 = 0.9139
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.83
         upper limit
    		 1.24
    Notes
    [27] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 8)
    Comparison groups
    FE 999302 (4 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [28]
    P-value
    		 = 0.2647
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.92
         upper limit
    		 1.38
    Notes
    [28] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 8)
    Comparison groups
    FE 999302 (8 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    211
    Analysis specification
    Pre-specified
    Analysis type
    		 other [29]
    P-value
    		 = 0.0007
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.42
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.16
         upper limit
    		 1.74
    Notes
    [29] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 8)
    Comparison groups
    FE 999302 (12 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [30]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.59
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.3
         upper limit
    		 1.95
    Notes
    [30] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (End-of-stimulation)
    Comparison groups
    FE 999302 (1 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [31]
    P-value
    		 = 0.8069
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.98
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.83
         upper limit
    		 1.16
    Notes
    [31] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (End-of-stimulation)
    Comparison groups
    FE 999302 (2 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    205
    Analysis specification
    Pre-specified
    Analysis type
    		 other [32]
    P-value
    		 = 0.4818
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 1.26
    Notes
    [32] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (End-of-stimulation)
    Comparison groups
    FE 999302 (4 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [33]
    P-value
    		 = 0.0754
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.98
         upper limit
    		 1.39
    Notes
    [33] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (End-of-stimulation)
    Comparison groups
    FE 999302 (8 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    211
    Analysis specification
    Pre-specified
    Analysis type
    		 other [34]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.65
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.39
         upper limit
    		 1.96
    Notes
    [34] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (End-of-stimulation)
    Comparison groups
    FE 999302 (12 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [35]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.54
         upper limit
    		 2.16
    Notes
    [35] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Oocyte retrieval)
    Comparison groups
    FE 999302 (1 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [36]
    P-value
    		 = 0.0885
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.73
         upper limit
    		 1.02
    Notes
    [36] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Oocyte retrieval)
    Comparison groups
    FE 999302 (2 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    205
    Analysis specification
    Pre-specified
    Analysis type
    		 other [37]
    P-value
    		 = 0.0146
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.68
         upper limit
    		 0.96
    Notes
    [37] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Oocyte retrieval)
    Comparison groups
    FE 999302 (4 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [38]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 0.84
    Notes
    [38] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Oocyte retrieval)
    Comparison groups
    FE 999302 (8 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    211
    Analysis specification
    Pre-specified
    Analysis type
    		 other [39]
    P-value
    		 = 0.0006
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.74
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.63
         upper limit
    		 0.88
    Notes
    [39] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Oocyte retrieval)
    Comparison groups
    FE 999302 (12 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [40]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 0.84
    Notes
    [40] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation day 1 as a covariate.

    Secondary: Changes in serum hormone (17-OH-progesterone) levels of from stimulation Day 1 to stimulation Day 6, stimulation Day 8, end-of-stimulation, and oocyte retrieval

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    End point title
    		 Changes in serum hormone (17-OH-progesterone) levels of from stimulation Day 1 to stimulation Day 6, stimulation Day 8, end-of-stimulation, and oocyte retrieval
    End point description
    Blood samples for analysis of serum hormone levels were drawn at stimulation Day 1, stimulation Day 6, stimulation Day 8, end-of-stimulation, and at oocyte retrieval. The analysis population included the FAS which consisted of all subjects who were randomised and started treatment with FE 999302 or placebo. Subjects were analysed according to the treatment they actually received. Timeframe: FE 999302 (1 µg), FE 999302 (2 µg), FE 999302 (4 µg), FE 999302 (8 µg), FE 999302 (12 µg), Placebo Stimulation day 6: n=103, n=99, n=97, n=105, n=104, n=102 Stimulation day 8: n=101, n=97, n=96, n=102, n=101, n=100 End-of-stimulation: n=102, n=99, n=99, n=104, n=104, n=101 Oocyte retrieval: n=102, n=99, n=98, n=106, n=103, n=98
    End point type
    Secondary
    End point timeframe
    Stimulation Day 1 (baseline), stimulation Day 6, stimulation Day 8, end-of-stimulation (up to 20 stimulation days), and oocyte retrieval
    End point values
    		 FE 999302 (1 μg) and Follitropin Delta FE 999302 (2 μg) and Follitropin Delta FE 999302 (4 μg) and Follitropin Delta FE 999302 (8 μg) and Follitropin Delta FE 999302 (12 μg) and Follitropin Delta Placebo and Follitropin Delta
    Number of subjects analysed
    104
    101
    99
    107
    104
    104
    Units: nmol/L
    arithmetic mean (standard deviation)
        Stimulation Day 6
    0.716 ( 0.612 )
    0.855 ( 1.052 )
    1.121 ( 0.835 )
    1.622 ( 1.251 )
    1.940 ( 1.428 )
    0.335 ( 0.585 )
        Stimulation Day 8
    1.542 ( 1.132 )
    2.026 ( 1.443 )
    2.594 ( 1.973 )
    3.701 ( 2.739 )
    4.123 ( 2.716 )
    1.076 ( 1.161 )
        End-of-stimulation visit
    4.840 ( 2.934 )
    5.559 ( 3.362 )
    7.025 ( 5.274 )
    10.022 ( 6.007 )
    10.605 ( 5.849 )
    3.635 ( 2.425 )
        Oocyte retrieval visit
    22.518 ( 10.417 )
    24.565 ( 12.943 )
    25.505 ( 14.471 )
    42.227 ( 144.990 )
    27.218 ( 13.283 )
    18.278 ( 8.826 )
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 6)
    Comparison groups
    FE 999302 (1 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [41]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.43
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.25
         upper limit
    		 1.64
    Notes
    [41] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 6)
    Comparison groups
    FE 999302 (2 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    205
    Analysis specification
    Pre-specified
    Analysis type
    		 other [42]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.68
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.46
         upper limit
    		 1.93
    Notes
    [42] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 6)
    Comparison groups
    FE 999302 (4 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [43]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.6
         upper limit
    		 2.12
    Notes
    [43] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 6)
    Comparison groups
    FE 999302 (8 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    211
    Analysis specification
    Pre-specified
    Analysis type
    		 other [44]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    2.45
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.14
         upper limit
    		 2.81
    Notes
    [44] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 6)
    Comparison groups
    FE 999302 (12 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [45]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    2.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.37
         upper limit
    		 3.11
    Notes
    [45] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 8)
    Comparison groups
    FE 999302 (1 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [46]
    P-value
    		 = 0.0008
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.12
         upper limit
    		 1.52
    Notes
    [46] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 8)
    Comparison groups
    FE 999302 (2 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    205
    Analysis specification
    Pre-specified
    Analysis type
    		 other [47]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.59
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.36
         upper limit
    		 1.86
    Notes
    [47] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 8)
    Comparison groups
    FE 999302 (4 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [48]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.58
         upper limit
    		 2.16
    Notes
    [48] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 8)
    Comparison groups
    FE 999302 (8 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    211
    Analysis specification
    Pre-specified
    Analysis type
    		 other [49]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    2.57
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.2
         upper limit
    		 2.99
    Notes
    [49] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 8)
    Comparison groups
    FE 999302 (12 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [50]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    2.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.41
         upper limit
    		 3.28
    Notes
    [50] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (End-of-stimulation)
    Comparison groups
    FE 999302 (1 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [51]
    P-value
    		 = 0.0025
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.27
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.09
         upper limit
    		 1.47
    Notes
    [51] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (End-of-stimulation)
    Comparison groups
    FE 999302 (2 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    205
    Analysis specification
    Pre-specified
    Analysis type
    		 other [52]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.27
         upper limit
    		 1.72
    Notes
    [52] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (End-of-stimulation)
    Comparison groups
    FE 999302 (4 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [53]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.5
         upper limit
    		 2.04
    Notes
    [53] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (End-of-stimulation)
    Comparison groups
    FE 999302 (8 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    211
    Analysis specification
    Pre-specified
    Analysis type
    		 other [54]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    2.55
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.19
         upper limit
    		 2.96
    Notes
    [54] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (End-of-stimulation)
    Comparison groups
    FE 999302 (12 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [55]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    2.7
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.32
         upper limit
    		 3.14
    Notes
    [55] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Oocyte retrieval)
    Comparison groups
    FE 999302 (1 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [56]
    P-value
    		 = 0.0198
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.19
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.03
         upper limit
    		 1.37
    Notes
    [56] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Oocyte retrieval)
    Comparison groups
    FE 999302 (2 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    205
    Analysis specification
    Pre-specified
    Analysis type
    		 other [57]
    P-value
    		 = 0.0003
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.13
         upper limit
    		 1.51
    Notes
    [57] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Oocyte retrieval)
    Comparison groups
    FE 999302 (4 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [58]
    P-value
    		 = 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.15
         upper limit
    		 1.54
    Notes
    [58] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Oocyte retrieval)
    Comparison groups
    FE 999302 (8 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    211
    Analysis specification
    Pre-specified
    Analysis type
    		 other [59]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.37
         upper limit
    		 1.83
    Notes
    [59] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Oocyte retrieval)
    Comparison groups
    FE 999302 (12 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [60]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.28
         upper limit
    		 1.71
    Notes
    [60] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.

    Secondary: Changes in serum hormone (androstenedione) levels from stimulation Day 1 to stimulation Day 6, stimulation Day 8, end-of-stimulation, and oocyte retrieval

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    End point title
    		 Changes in serum hormone (androstenedione) levels from stimulation Day 1 to stimulation Day 6, stimulation Day 8, end-of-stimulation, and oocyte retrieval
    End point description
    Blood samples for analysis of serum hormone levels were drawn at stimulation Day 1, stimulation Day 6, stimulation Day 8, end-of-stimulation, and at oocyte retrieval. The analysis population included the FAS which consisted of all subjects who were randomised and started treatment with FE 999302 or placebo. Subjects were analysed according to the treatment they actually received. Timeframe: FE 999302 (1 µg), FE 999302 (2 µg), FE 999302 (4 µg), FE 999302 (8 µg), FE 999302 (12 µg), Placebo Stimulation day 6: n=104, n=100, n=97, n=105, n=103, n=103 Stimulation day 8: n=102, n=97, n=95, n=103, n=100, n=101 End-of-stimulation: n=104, n=99, n=99, n=104, n=103, n=102 Oocyte retrieval: n=103, n=100, n=98, n=106, n=102, n=101
    End point type
    Secondary
    End point timeframe
    Stimulation Day 1 (baseline), stimulation Day 6, stimulation Day 8, end-of-stimulation (up to 20 stimulation days), and oocyte retrieval
    End point values
    		 FE 999302 (1 μg) and Follitropin Delta FE 999302 (2 μg) and Follitropin Delta FE 999302 (4 μg) and Follitropin Delta FE 999302 (8 μg) and Follitropin Delta FE 999302 (12 μg) and Follitropin Delta Placebo and Follitropin Delta
    Number of subjects analysed
    104
    101
    99
    107
    104
    104
    Units: nmol/L
    arithmetic mean (standard deviation)
        Stimulation Day 6
    0.91 ( 0.97 )
    1.26 ( 1.23 )
    1.29 ( 1.21 )
    1.86 ( 1.48 )
    2.17 ( 1.60 )
    0.35 ( 0.95 )
        Stimulation Day 8
    2.02 ( 1.44 )
    2.77 ( 2.12 )
    3.19 ( 2.12 )
    4.44 ( 3.09 )
    4.65 ( 2.82 )
    1.22 ( 1.51 )
        End-of-stimulation visit
    5.48 ( 2.97 )
    6.37 ( 3.73 )
    7.64 ( 4.64 )
    9.99 ( 5.39 )
    9.66 ( 5.01 )
    3.03 ( 2.13 )
        Oocyte retrieval visit
    6.50 ( 3.49 )
    7.17 ( 4.01 )
    8.58 ( 3.88 )
    10.76 ( 5.48 )
    10.34 ( 5.10 )
    4.06 ( 2.54 )
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 6)
    Comparison groups
    FE 999302 (1 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [61]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.09
         upper limit
    		 1.28
    Notes
    [61] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 6)
    Comparison groups
    FE 999302 (2 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    205
    Analysis specification
    Pre-specified
    Analysis type
    		 other [62]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.19
         upper limit
    		 1.4
    Notes
    [62] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 6)
    Comparison groups
    FE 999302 (4 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [63]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.32
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.21
         upper limit
    		 1.43
    Notes
    [63] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 6)
    Comparison groups
    FE 999302 (8 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    211
    Analysis specification
    Pre-specified
    Analysis type
    		 other [64]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.39
         upper limit
    		 1.63
    Notes
    [64] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 6)
    Comparison groups
    FE 999302 (12 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [65]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.59
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.47
         upper limit
    		 1.72
    Notes
    [65] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 8)
    Comparison groups
    FE 999302 (1 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [66]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.23
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.11
         upper limit
    		 1.35
    Notes
    [66] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 8)
    Comparison groups
    FE 999302 (2 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    205
    Analysis specification
    Pre-specified
    Analysis type
    		 other [67]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.38
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.25
         upper limit
    		 1.52
    Notes
    [67] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 8)
    Comparison groups
    FE 999302 (4 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [68]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.51
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.37
         upper limit
    		 1.67
    Notes
    [68] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 8)
    Comparison groups
    FE 999302 (8 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    211
    Analysis specification
    Pre-specified
    Analysis type
    		 other [69]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.67
         upper limit
    		 2.02
    Notes
    [69] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 8)
    Comparison groups
    FE 999302 (12 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [70]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.7
         upper limit
    		 2.06
    Notes
    [70] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (End-of-stimulation)
    Comparison groups
    FE 999302 (1 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [71]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.41
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.27
         upper limit
    		 1.56
    Notes
    [71] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (End-of-stimulation)
    Comparison groups
    FE 999302 (2 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    205
    Analysis specification
    Pre-specified
    Analysis type
    		 other [72]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.57
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.41
         upper limit
    		 1.74
    Notes
    [72] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (End-of-stimulation)
    Comparison groups
    FE 999302 (4 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [73]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.78
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.6
         upper limit
    		 1.98
    Notes
    [73] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (End-of-stimulation)
    Comparison groups
    FE 999302 (8 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    211
    Analysis specification
    Pre-specified
    Analysis type
    		 other [74]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    2.21
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2
         upper limit
    		 2.45
    Notes
    [74] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (End-of-stimulation)
    Comparison groups
    FE 999302 (12 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [75]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    2.17
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.96
         upper limit
    		 2.41
    Notes
    [75] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Oocyte retrieval)
    Comparison groups
    FE 999302 (1 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [76]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.34
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.21
         upper limit
    		 1.48
    Notes
    [76] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Oocyte retrieval)
    Comparison groups
    FE 999302 (2 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    205
    Analysis specification
    Pre-specified
    Analysis type
    		 other [77]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.44
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.31
         upper limit
    		 1.59
    Notes
    [77] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Oocyte retrieval)
    Comparison groups
    FE 999302 (4 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [78]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.69
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.53
         upper limit
    		 1.87
    Notes
    [78] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Oocyte retrieval)
    Comparison groups
    FE 999302 (8 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    211
    Analysis specification
    Pre-specified
    Analysis type
    		 other [79]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.81
         upper limit
    		 2.2
    Notes
    [79] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Oocyte retrieval)
    Comparison groups
    FE 999302 (12 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [80]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.75
         upper limit
    		 2.14
    Notes
    [80] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.

    Secondary: Changes in serum hormone (testosterone) levels from stimulation Day 1 to stimulation Day 6, stimulation Day 8, end-of-stimulation, and oocyte retrieval

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    End point title
    		 Changes in serum hormone (testosterone) levels from stimulation Day 1 to stimulation Day 6, stimulation Day 8, end-of-stimulation, and oocyte retrieval
    End point description
    Blood samples for analysis of serum hormone levels were drawn at stimulation Day 1, stimulation Day 6, stimulation Day 8, end-of-stimulation, and at oocyte retrieval. The analysis population included the FAS which consisted of all subjects who were randomised and started treatment with FE 999302 or placebo. Subjects were analysed according to the treatment they actually received. Timeframe: FE 999302 (1 µg), FE 999302 (2 µg), FE 999302 (4 µg), FE 999302 (8 µg), FE 999302 (12 µg), Placebo Stimulation day 6: n=101, n=98, n=97, n=105, n=103, n=102 Stimulation day 8: n=100, n=96, n=95, n=103, n=100, n=100 End-of-stimulation: n=101, n=98, n=99, n=104, n=103, n=100 Oocyte retrieval: n=101, n=98, n=98, n=106, n=103, n=100
    End point type
    Secondary
    End point timeframe
    Stimulation Day 1 (baseline), stimulation Day 6, stimulation Day 8, end-of-stimulation (up to 20 stimulation days), and oocyte retrieval
    End point values
    		 FE 999302 (1 μg) and Follitropin Delta FE 999302 (2 μg) and Follitropin Delta FE 999302 (4 μg) and Follitropin Delta FE 999302 (8 μg) and Follitropin Delta FE 999302 (12 μg) and Follitropin Delta Placebo and Follitropin Delta
    Number of subjects analysed
    104
    101
    99
    107
    104
    104
    Units: nmol/L
    arithmetic mean (standard deviation)
        Stimulation Day 6
    0.152 ( 0.201 )
    0.190 ( 0.252 )
    0.224 ( 0.226 )
    0.319 ( 0.317 )
    0.371 ( 0.335 )
    0.039 ( 0.187 )
        Stimulation Day 8
    0.382 ( 0.299 )
    0.414 ( 0.396 )
    0.604 ( 0.467 )
    0.824 ( 0.616 )
    0.847 ( 0.575 )
    0.195 ( 0.277 )
        End-of-stimulation visit
    1.178 ( 0.736 )
    1.252 ( 0.786 )
    1.605 ( 1.097 )
    2.296 ( 1.380 )
    2.106 ( 1.165 )
    0.669 ( 0.472 )
        Oocyte retrieval visit
    2.088 ( 1.105 )
    2.213 ( 1.198 )
    2.691 ( 1.321 )
    3.394 ( 1.780 )
    3.136 ( 1.586 )
    1.374 ( 0.798 )
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 6)
    Comparison groups
    FE 999302 (1 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [81]
    P-value
    		 = 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.18
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.07
         upper limit
    		 1.31
    Notes
    [81] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 6)
    Comparison groups
    FE 999302 (2 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    205
    Analysis specification
    Pre-specified
    Analysis type
    		 other [82]
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.26
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.14
         upper limit
    		 1.39
    Notes
    [82] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 6)
    Comparison groups
    FE 999302 (4 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [83]
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.23
         upper limit
    		 1.5
    Notes
    [83] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 6)
    Comparison groups
    FE 999302 (8 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    211
    Analysis specification
    Pre-specified
    Analysis type
    		 other [84]
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.53
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.39
         upper limit
    		 1.69
    Notes
    [84] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 6)
    Comparison groups
    FE 999302 (12 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [85]
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.62
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.46
         upper limit
    		 1.79
    Notes
    [85] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 8)
    Comparison groups
    FE 999302 (1 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [86]
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.28
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.14
         upper limit
    		 1.43
    Notes
    [86] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 8)
    Comparison groups
    FE 999302 (2 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    205
    Analysis specification
    Pre-specified
    Analysis type
    		 other [87]
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.3
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.16
         upper limit
    		 1.46
    Notes
    [87] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 8)
    Comparison groups
    FE 999302 (4 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [88]
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.59
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.42
         upper limit
    		 1.79
    Notes
    [88] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 8)
    Comparison groups
    FE 999302 (8 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    211
    Analysis specification
    Pre-specified
    Analysis type
    		 other [89]
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.71
         upper limit
    		 2.14
    Notes
    [89] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 8)
    Comparison groups
    FE 999302 (12 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [90]
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.74
         upper limit
    		 2.17
    Notes
    [90] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (End-of-stimulation)
    Comparison groups
    FE 999302 (1 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [91]
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.42
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.25
         upper limit
    		 1.6
    Notes
    [91] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (End-of-stimulation)
    Comparison groups
    FE 999302 (2 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    205
    Analysis specification
    Pre-specified
    Analysis type
    		 other [92]
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.31
         upper limit
    		 1.67
    Notes
    [92] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (End-of-stimulation)
    Comparison groups
    FE 999302 (4 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [93]
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.76
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.56
         upper limit
    		 1.99
    Notes
    [93] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (End-of-stimulation)
    Comparison groups
    FE 999302 (8 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    211
    Analysis specification
    Pre-specified
    Analysis type
    		 other [94]
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    2.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 2.1
         upper limit
    		 2.68
    Notes
    [94] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (End-of-stimulation)
    Comparison groups
    FE 999302 (12 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [95]
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    2.25
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.99
         upper limit
    		 2.54
    Notes
    [95] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Oocyte retrieval)
    Comparison groups
    FE 999302 (1 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [96]
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.36
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.21
         upper limit
    		 1.52
    Notes
    [96] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Oocyte retrieval)
    Comparison groups
    FE 999302 (2 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    205
    Analysis specification
    Pre-specified
    Analysis type
    		 other [97]
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.45
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.29
         upper limit
    		 1.62
    Notes
    [97] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Oocyte retrieval)
    Comparison groups
    FE 999302 (4 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [98]
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.53
         upper limit
    		 1.92
    Notes
    [98] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Oocyte retrieval)
    Comparison groups
    FE 999302 (8 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    211
    Analysis specification
    Pre-specified
    Analysis type
    		 other [99]
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    2.09
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.87
         upper limit
    		 2.33
    Notes
    [99] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Oocyte retrieval)
    Comparison groups
    FE 999302 (12 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [100]
    P-value
    		 < 0.001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.75
         upper limit
    		 2.19
    Notes
    [100] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.

    Secondary: Changes in serum hormone (estradiol) levels from stimulation Day 1 to stimulation Day 6, stimulation Day 8, end-of-stimulation, and oocyte retrieval

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    End point title
    		 Changes in serum hormone (estradiol) levels from stimulation Day 1 to stimulation Day 6, stimulation Day 8, end-of-stimulation, and oocyte retrieval
    End point description
    Blood samples for analysis of serum hormone levels were drawn at stimulation Day 1, stimulation Day 6, stimulation Day 8, end-of-stimulation, and at oocyte retrieval. The analysis population included the FAS which consisted of all subjects who were randomised and started treatment with FE 999302 or placebo. Subjects were analysed according to the treatment they actually received. Timeframe: FE 999302 (1 µg), FE 999302 (2 µg), FE 999302 (4 µg), FE 999302 (8 µg), FE 999302 (12 µg), Placebo Stimulation day 6: n=101, n=96, n=96, n=101, n=101, n=101 Stimulation day 8: n=99, n=93, n=94, n=99, n=100, n=100 End-of-stimulation: n=102, n=93, n=97, n=99, n=100, n=101 Oocyte retrieval: n=100, n=94, n=94, n=98, n=98, n=99
    End point type
    Secondary
    End point timeframe
    Stimulation Day 1 (baseline), stimulation Day 6, stimulation Day 8, end-of-stimulation (up to 20 stimulation days), and oocyte retrieval
    End point values
    		 FE 999302 (1 μg) and Follitropin Delta FE 999302 (2 μg) and Follitropin Delta FE 999302 (4 μg) and Follitropin Delta FE 999302 (8 μg) and Follitropin Delta FE 999302 (12 μg) and Follitropin Delta Placebo and Follitropin Delta
    Number of subjects analysed
    104
    101
    99
    107
    104
    104
    Units: pmol/L
    arithmetic mean (standard deviation)
        Stimulation Day 6
    1183.4 ( 813.0 )
    1413.4 ( 1028.7 )
    1412.5 ( 1154.1 )
    1612.9 ( 1098.4 )
    1619.1 ( 1242.4 )
    880.7 ( 959.2 )
        Stimulation Day 8
    2994.9 ( 1692.1 )
    3526.3 ( 2186.1 )
    3707.9 ( 3100.8 )
    4204.8 ( 2478.1 )
    3969.7 ( 2364.1 )
    2257.9 ( 1704.3 )
        End-of-stimulation visit
    9119.7 ( 4984.4 )
    10006.3 ( 5322.4 )
    10640.9 ( 6305.4 )
    12705.8 ( 7412.0 )
    11098.9 ( 5905.2 )
    6864.6 ( 3706.8 )
        Oocyte retrieval visit
    4410.7 ( 2308.4 )
    4781.2 ( 2299.5 )
    5925.5 ( 4389.5 )
    7672.5 ( 10951.6 )
    6502.4 ( 2957.4 )
    3273.2 ( 1729.9 )
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 6)
    Comparison groups
    FE 999302 (1 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [101]
    P-value
    		 = 0.0095
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.31
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.07
         upper limit
    		 1.61
    Notes
    [101] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 6)
    Comparison groups
    FE 999302 (2 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    205
    Analysis specification
    Pre-specified
    Analysis type
    		 other [102]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.57
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.27
         upper limit
    		 1.93
    Notes
    [102] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 6)
    Comparison groups
    FE 999302 (4 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [103]
    P-value
    		 = 0.0002
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.48
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.2
         upper limit
    		 1.82
    Notes
    [103] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 6)
    Comparison groups
    FE 999302 (8 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    211
    Analysis specification
    Pre-specified
    Analysis type
    		 other [104]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.51
         upper limit
    		 2.27
    Notes
    [104] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 6)
    Comparison groups
    FE 999302 (12 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [105]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.69
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.37
         upper limit
    		 2.07
    Notes
    [105] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 8)
    Comparison groups
    FE 999302 (1 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [106]
    P-value
    		 = 0.0016
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.37
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.13
         upper limit
    		 1.67
    Notes
    [106] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 8)
    Comparison groups
    FE 999302 (2 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    205
    Analysis specification
    Pre-specified
    Analysis type
    		 other [107]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.63
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.34
         upper limit
    		 1.99
    Notes
    [107] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 8)
    Comparison groups
    Placebo and Follitropin Delta v FE 999302 (4 μg) and Follitropin Delta
    Number of subjects included in analysis
    203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [108]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.64
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.34
         upper limit
    		 2
    Notes
    [108] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 8)
    Comparison groups
    FE 999302 (8 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    211
    Analysis specification
    Pre-specified
    Analysis type
    		 other [109]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.59
         upper limit
    		 2.35
    Notes
    [109] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 8)
    Comparison groups
    FE 999302 (12 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [110]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.48
         upper limit
    		 2.18
    Notes
    [110] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (End-of-stimulation)
    Comparison groups
    FE 999302 (1 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [111]
    P-value
    		 = 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.32
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.15
         upper limit
    		 1.52
    Notes
    [111] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (End-of-stimulation)
    Comparison groups
    Placebo and Follitropin Delta v FE 999302 (2 μg) and Follitropin Delta
    Number of subjects included in analysis
    205
    Analysis specification
    Pre-specified
    Analysis type
    		 other [112]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.47
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.27
         upper limit
    		 1.7
    Notes
    [112] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (End-of-stimulation)
    Comparison groups
    FE 999302 (4 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [113]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.54
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.34
         upper limit
    		 1.78
    Notes
    [113] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (End-of-stimulation)
    Comparison groups
    Placebo and Follitropin Delta v FE 999302 (8 μg) and Follitropin Delta
    Number of subjects included in analysis
    211
    Analysis specification
    Pre-specified
    Analysis type
    		 other [114]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.62
         upper limit
    		 2.16
    Notes
    [114] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (End-of-stimulation)
    Comparison groups
    FE 999302 (12 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [115]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.64
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.42
         upper limit
    		 1.89
    Notes
    [115] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Oocyte retrieval)
    Comparison groups
    FE 999302 (1 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [116]
    P-value
    		 = 0.0004
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.33
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.13
         upper limit
    		 1.55
    Notes
    [116] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Oocyte retrieval)
    Comparison groups
    FE 999302 (2 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    205
    Analysis specification
    Pre-specified
    Analysis type
    		 other [117]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.47
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.25
         upper limit
    		 1.72
    Notes
    [117] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Oocyte retrieval)
    Comparison groups
    FE 999302 (4 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [118]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.66
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.41
         upper limit
    		 1.94
    Notes
    [118] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Oocyte retrieval)
    Comparison groups
    FE 999302 (8 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    211
    Analysis specification
    Pre-specified
    Analysis type
    		 other [119]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    2.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.84
         upper limit
    		 2.52
    Notes
    [119] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Oocyte retrieval)
    Comparison groups
    FE 999302 (12 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [120]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    2.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.73
         upper limit
    		 2.36
    Notes
    [120] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.

    Secondary: Changes in serum hormone (inhibin A) levels from stimulation Day 1 to stimulation Day 6, stimulation Day 8, and end-of-stimulation

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    End point title
    		 Changes in serum hormone (inhibin A) levels from stimulation Day 1 to stimulation Day 6, stimulation Day 8, and end-of-stimulation
    End point description
    Blood samples for analysis serum hormone levels were drawn at stimulation Day 1, stimulation Day 6, stimulation Day 8, and at end-of-stimulation. The analysis population included the FAS which consisted of all subjects who were randomised and started treatment with FE 999302 or placebo. Subjects were analysed according to the treatment they actually received. Timeframe: FE 999302 (1 µg), FE 999302 (2 µg), FE 999302 (4 µg), FE 999302 (8 µg), FE 999302 (12 µg), Placebo Stimulation day 6: n=94, n=94, n=94, n=100, n=100, n=90 Stimulation day 8: n=94, n=94, n=93, n=97, n=93, n=89 End-of-stimulation: n=95, n=95, n=93, n=99, n=101, n=89
    End point type
    Secondary
    End point timeframe
    Stimulation Day 1 (baseline), Stimulation Day 6, stimulation Day 8, and end-of-stimulation (up to 20 stimulation days)
    End point values
    		 FE 999302 (1 μg) and Follitropin Delta FE 999302 (2 μg) and Follitropin Delta FE 999302 (4 μg) and Follitropin Delta FE 999302 (8 μg) and Follitropin Delta FE 999302 (12 μg) and Follitropin Delta Placebo and Follitropin Delta
    Number of subjects analysed
    104
    101
    99
    107
    104
    104
    Units: ng/L
    arithmetic mean (standard deviation)
        Stimulation Day 6
    57.0 ( 43.7 )
    62.1 ( 42.8 )
    56.9 ( 40.2 )
    61.0 ( 45.9 )
    61.7 ( 47.2 )
    58.1 ( 42.2 )
        Stimulation Day 8
    145.7 ( 88.3 )
    151.6 ( 88.4 )
    140.7 ( 80.0 )
    155.1 ( 101.1 )
    149.4 ( 92.8 )
    148.2 ( 90.0 )
        End-of-stimulation visit
    380.1 ( 148.5 )
    367.3 ( 158.1 )
    356.4 ( 153.6 )
    368.2 ( 179.5 )
    319.1 ( 148.9 )
    398.0 ( 165.7 )
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 6)
    Comparison groups
    FE 999302 (1 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [121]
    P-value
    		 = 0.7029
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.78
         upper limit
    		 1.18
    Notes
    [121] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 6)
    Comparison groups
    FE 999302 (2 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    205
    Analysis specification
    Pre-specified
    Analysis type
    		 other [122]
    P-value
    		 = 0.4906
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.87
         upper limit
    		 1.33
    Notes
    [122] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 6)
    Comparison groups
    FE 999302 (4 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [123]
    P-value
    		 = 0.8638
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.82
         upper limit
    		 1.26
    Notes
    [123] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 6)
    Comparison groups
    FE 999302 (8 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    211
    Analysis specification
    Pre-specified
    Analysis type
    		 other [124]
    P-value
    		 = 0.4434
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.88
         upper limit
    		 1.33
    Notes
    [124] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 6)
    Comparison groups
    FE 999302 (12 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [125]
    P-value
    		 = 0.9426
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.81
         upper limit
    		 1.22
    Notes
    [125] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 8)
    Comparison groups
    FE 999302 (1 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [126]
    P-value
    		 = 0.5904
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.79
         upper limit
    		 1.14
    Notes
    [126] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 8)
    Comparison groups
    FE 999302 (2 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    205
    Analysis specification
    Pre-specified
    Analysis type
    		 other [127]
    P-value
    		 = 0.5444
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.88
         upper limit
    		 1.27
    Notes
    [127] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 8)
    Comparison groups
    FE 999302 (4 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [128]
    P-value
    		 = 0.9847
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.83
         upper limit
    		 1.21
    Notes
    [128] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 8)
    Comparison groups
    FE 999302 (8 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    211
    Analysis specification
    Pre-specified
    Analysis type
    		 other [129]
    P-value
    		 = 0.4027
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.08
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 1.3
    Notes
    [129] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 8)
    Comparison groups
    FE 999302 (12 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [130]
    P-value
    		 = 0.8388
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.98
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.81
         upper limit
    		 1.18
    Notes
    [130] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (End-of-stimulation)
    Comparison groups
    FE 999302 (1 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [131]
    P-value
    		 = 0.3474
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.94
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.83
         upper limit
    		 1.07
    Notes
    [131] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (End-of-stimulation)
    Comparison groups
    FE 999302 (2 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    205
    Analysis specification
    Pre-specified
    Analysis type
    		 other [132]
    P-value
    		 = 0.1652
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.81
         upper limit
    		 1.04
    Notes
    [132] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (End-of-stimulation)
    Comparison groups
    FE 999302 (4 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [133]
    P-value
    		 = 0.1168
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8
         upper limit
    		 1.03
    Notes
    [133] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (End-of-stimulation)
    Comparison groups
    FE 999302 (8 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    211
    Analysis specification
    Pre-specified
    Analysis type
    		 other [134]
    P-value
    		 = 0.1567
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.92
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.81
         upper limit
    		 1.03
    Notes
    [134] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (End-of-stimulation)
    Comparison groups
    FE 999302 (12 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [135]
    P-value
    		 = 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.79
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 0.89
    Notes
    [135] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.

    Secondary: Changes in serum hormone (inhibin B) levels from stimulation Day 1 to stimulation Day 6, stimulation Day 8, and end-of-stimulation

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    End point title
    		 Changes in serum hormone (inhibin B) levels from stimulation Day 1 to stimulation Day 6, stimulation Day 8, and end-of-stimulation
    End point description
    Blood samples for analysis of serum hormone levels were drawn at stimulation Day 1, stimulation Day 6, stimulation Day 8, and at end-of-stimulation. The analysis population included the FAS which consisted of all subjects who were randomised and started treatment with FE 999302 or placebo. Subjects were analysed according to the treatment they actually received. Timeframe: FE 999302 (1 µg), FE 999302 (2 µg), FE 999302 (4 µg), FE 999302 (8 µg), FE 999302 (12 µg), Placebo Stimulation day 6: n=99, n=97, n=95, n=103, n=103, n=96 Stimulation day 8: n=98, n=95, n=93, n=101, n=98, n=94 End-of-stimulation: n=97, n=94, n=94, n=102, n=103, n=94
    End point type
    Secondary
    End point timeframe
    Stimulation Day 1 (baseline), Stimulation Day 6, stimulation Day 8, and end-of-stimulation (up to 20 stimulation days)
    End point values
    		 FE 999302 (1 μg) and Follitropin Delta FE 999302 (2 μg) and Follitropin Delta FE 999302 (4 μg) and Follitropin Delta FE 999302 (8 μg) and Follitropin Delta FE 999302 (12 μg) and Follitropin Delta Placebo and Follitropin Delta
    Number of subjects analysed
    104
    101
    99
    107
    104
    104
    Units: ng/L
    arithmetic mean (standard deviation)
        Stimulation Day 6
    527.4 ( 256.8 )
    538.2 ( 283.7 )
    475.2 ( 258.1 )
    505.3 ( 255.8 )
    456.0 ( 269.2 )
    535.4 ( 275.8 )
        Stimulation Day 8
    735.1 ( 271.2 )
    684.9 ( 274.5 )
    650.7 ( 256.8 )
    652.5 ( 261.9 )
    569.1 ( 261.6 )
    717.7 ( 291.7 )
        End-of-stimulation visit
    731.7 ( 285.8 )
    668.7 ( 275.4 )
    662.0 ( 268.5 )
    620.5 ( 264.5 )
    531.5 ( 264.9 )
    742.0 ( 287.2 )
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 6)
    Comparison groups
    FE 999302 (1 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [136]
    P-value
    		 = 0.8145
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.86
         upper limit
    		 1.21
    Notes
    [136] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 6)
    Comparison groups
    FE 999302 (2 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    205
    Analysis specification
    Pre-specified
    Analysis type
    		 other [137]
    P-value
    		 = 0.8796
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.86
         upper limit
    		 1.2
    Notes
    [137] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 6)
    Comparison groups
    FE 999302 (4 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [138]
    P-value
    		 = 0.1413
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.74
         upper limit
    		 1.04
    Notes
    [138] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 6)
    Comparison groups
    FE 999302 (8 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    211
    Analysis specification
    Pre-specified
    Analysis type
    		 other [139]
    P-value
    		 = 0.898
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.84
         upper limit
    		 1.17
    Notes
    [139] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 6)
    Comparison groups
    FE 999302 (12 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [140]
    P-value
    		 = 0.02
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.69
         upper limit
    		 0.97
    Notes
    [140] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 8)
    Comparison groups
    FE 999302 (1 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [141]
    P-value
    		 = 0.7899
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.89
         upper limit
    		 1.17
    Notes
    [141] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 8)
    Comparison groups
    FE 999302 (2 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    205
    Analysis specification
    Pre-specified
    Analysis type
    		 other [142]
    P-value
    		 = 0.4413
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.83
         upper limit
    		 1.09
    Notes
    [142] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 8)
    Comparison groups
    FE 999302 (4 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [143]
    P-value
    		 = 0.1804
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.91
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.79
         upper limit
    		 1.04
    Notes
    [143] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 8)
    Comparison groups
    FE 999302 (8 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    211
    Analysis specification
    Pre-specified
    Analysis type
    		 other [144]
    P-value
    		 = 0.2936
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.81
         upper limit
    		 1.06
    Notes
    [144] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 8)
    Comparison groups
    FE 999302 (12 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [145]
    P-value
    		 = 0.0002
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.77
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.67
         upper limit
    		 0.88
    Notes
    [145] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (End-of-stimulation)
    Comparison groups
    FE 999302 (1 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [146]
    P-value
    		 = 0.5204
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.84
         upper limit
    		 1.09
    Notes
    [146] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (End-of-stimulation)
    Comparison groups
    FE 999302 (2 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    205
    Analysis specification
    Pre-specified
    Analysis type
    		 other [147]
    P-value
    		 = 0.0468
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.88
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.77
         upper limit
    		 1
    Notes
    [147] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (End-of-stimulation)
    Comparison groups
    FE 999302 (4 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [148]
    P-value
    		 = 0.0417
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.77
         upper limit
    		 0.99
    Notes
    [148] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (End-of-stimulation)
    Comparison groups
    FE 999302 (8 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    211
    Analysis specification
    Pre-specified
    Analysis type
    		 other [149]
    P-value
    		 = 0.0084
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.74
         upper limit
    		 0.96
    Notes
    [149] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 8)
    Comparison groups
    FE 999302 (12 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [150]
    P-value
    		 < 0.0001
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.69
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.6
         upper limit
    		 0.78
    Notes
    [150] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.

    Secondary: Changes in serum hormone (follicle stimulating hormone [FSH]) levels of from stimulation Day 1 to stimulation Day 6, stimulation Day 8, and end-of-stimulation

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    End point title
    		 Changes in serum hormone (follicle stimulating hormone [FSH]) levels of from stimulation Day 1 to stimulation Day 6, stimulation Day 8, and end-of-stimulation
    End point description
    Blood samples for analysis of serum hormone levels were drawn at stimulation Day 1, stimulation Day 6, stimulation Day 8, at end-of-stimulation. The analysis population included the FAS which consisted of all subjects who were randomised and started treatment with FE 999302 or placebo. Subjects were analysed according to the treatment they actually received. Timeframe: FE 999302 (1 µg), FE 999302 (2 µg), FE 999302 (4 µg), FE 999302 (8 µg), FE 999302 (12 µg), Placebo Stimulation day 6: n=103, n=101, n=94, n=104, n=104, n=101 Stimulation day 8: n=99, n=96, n=93, n=103, n=101, n=99 End-of-stimulation: n=102, n=99, n=97, n=103, n=102, n=101
    End point type
    Secondary
    End point timeframe
    Stimulation Day 1 (baseline), stimulation Day 6, stimulation Day 8, and end-of-stimulation (up to 20 stimulation days)
    End point values
    		 FE 999302 (1 μg) and Follitropin Delta FE 999302 (2 μg) and Follitropin Delta FE 999302 (4 μg) and Follitropin Delta FE 999302 (8 μg) and Follitropin Delta FE 999302 (12 μg) and Follitropin Delta Placebo and Follitropin Delta
    Number of subjects analysed
    104
    101
    99
    107
    104
    104
    Units: IU/L
    arithmetic mean (standard deviation)
        Stimulation Day 6
    10.77 ( 3.39 )
    11.57 ( 3.51 )
    11.44 ( 3.85 )
    10.95 ( 3.20 )
    11.08 ( 3.72 )
    11.03 ( 3.55 )
        Stimulation Day 8
    11.16 ( 3.48 )
    12.19 ( 4.02 )
    12.12 ( 4.22 )
    11.56 ( 3.58 )
    11.93 ( 4.20 )
    11.60 ( 3.50 )
        End-of-stimulation visit
    11.11 ( 3.54 )
    12.20 ( 4.31 )
    11.87 ( 3.91 )
    11.67 ( 3.73 )
    11.92 ( 4.41 )
    11.73 ( 3.87 )
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 6)
    Comparison groups
    FE 999302 (1 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [151]
    P-value
    		 = 0.8378
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.94
         upper limit
    		 1.05
    Notes
    [151] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 6)
    Comparison groups
    FE 999302 (2 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    205
    Analysis specification
    Pre-specified
    Analysis type
    		 other [152]
    P-value
    		 = 0.2155
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.98
         upper limit
    		 1.09
    Notes
    [152] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 6)
    Comparison groups
    FE 999302 (4 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [153]
    P-value
    		 = 0.5823
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.96
         upper limit
    		 1.07
    Notes
    [153] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 6)
    Comparison groups
    FE 999302 (8 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    211
    Analysis specification
    Pre-specified
    Analysis type
    		 other [154]
    P-value
    		 = 0.9766
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.95
         upper limit
    		 1.05
    Notes
    [154] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 6)
    Comparison groups
    FE 999302 (12 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [155]
    P-value
    		 = 0.7826
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.96
         upper limit
    		 1.06
    Notes
    [155] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 8)
    Comparison groups
    FE 999302 (1 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [156]
    P-value
    		 = 0.5283
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.98
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.93
         upper limit
    		 1.04
    Notes
    [156] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 8)
    Comparison groups
    FE 999302 (2 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    205
    Analysis specification
    Pre-specified
    Analysis type
    		 other [157]
    P-value
    		 = 0.2565
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.98
         upper limit
    		 1.1
    Notes
    [157] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 8)
    Comparison groups
    FE 999302 (4 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [158]
    P-value
    		 = 0.671
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.96
         upper limit
    		 1.07
    Notes
    [158] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 8)
    Comparison groups
    FE 999302 (8 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    211
    Analysis specification
    Pre-specified
    Analysis type
    		 other [159]
    P-value
    		 = 0.9139
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.94
         upper limit
    		 1.06
    Notes
    [159] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 8)
    Comparison groups
    FE 999302 (12 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [160]
    P-value
    		 = 0.3999
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.97
         upper limit
    		 1.09
    Notes
    [160] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (End-of-stimulation)
    Comparison groups
    FE 999302 (1 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [161]
    P-value
    		 = 0.4039
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.98
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.92
         upper limit
    		 1.03
    Notes
    [161] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (End-of-stimulation)
    Comparison groups
    FE 999302 (2 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    205
    Analysis specification
    Pre-specified
    Analysis type
    		 other [162]
    P-value
    		 = 0.5442
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.02
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.96
         upper limit
    		 1.08
    Notes
    [162] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (End-of-stimulation)
    Comparison groups
    FE 999302 (4 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [163]
    P-value
    		 = 0.7983
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.94
         upper limit
    		 1.05
    Notes
    [163] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (End-of-stimulation)
    Comparison groups
    FE 999302 (8 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    211
    Analysis specification
    Pre-specified
    Analysis type
    		 other [164]
    P-value
    		 = 0.8476
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.94
         upper limit
    		 1.05
    Notes
    [164] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (End-of-stimulation)
    Comparison groups
    FE 999302 (12 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [165]
    P-value
    		 = 0.6936
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.01
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.96
         upper limit
    		 1.07
    Notes
    [165] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.

    Secondary: Changes in serum hormone (luteinising hormone [LH]) levels from stimulation Day 1 to stimulation Day 6, stimulation Day 8, and end-of-stimulation

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    End point title
    		 Changes in serum hormone (luteinising hormone [LH]) levels from stimulation Day 1 to stimulation Day 6, stimulation Day 8, and end-of-stimulation
    End point description
    Blood samples for analysis of hormone concentrations are drawn at stimulation Day 1, stimulation Day 6, stimulation Day 8, and at end-of-stimulation. The analysis population included the FAS which consisted of all subjects who were randomised and started treatment with FE 999302 or placebo. Subjects were analysed according to the treatment they actually received. Timeframe: FE 999302 (1 µg), FE 999302 (2 µg), FE 999302 (4 µg), FE 999302 (8 µg), FE 999302 (12 µg), Placebo Stimulation day 6: n=103, n=101, n=97, n=104, n=104, n=102 Stimulation day 8: n=100, n=97, n=95, n=103, n=101, n=100 End-of-stimulation: n=103, n=99, n=99, n=103, n=102, n=101
    End point type
    Secondary
    End point timeframe
    Stimulation Day 1 (baseline), stimulation Day 6, stimulation Day 8, and end-of-stimulation (up to 20 stimulation days)
    End point values
    		 FE 999302 (1 μg) and Follitropin Delta FE 999302 (2 μg) and Follitropin Delta FE 999302 (4 μg) and Follitropin Delta FE 999302 (8 μg) and Follitropin Delta FE 999302 (12 μg) and Follitropin Delta Placebo and Follitropin Delta
    Number of subjects analysed
    104
    101
    99
    107
    104
    104
    Units: IU/L
    arithmetic mean (standard deviation)
        Stimulation Day 6
    -0.75 ( 0.72 )
    -0.79 ( 0.86 )
    -0.66 ( 0.75 )
    -0.76 ( 0.88 )
    -0.80 ( 0.75 )
    -0.75 ( 0.75 )
        Stimulation Day 8
    -0.70 ( 0.83 )
    -0.78 ( 0.99 )
    -0.67 ( 0.93 )
    -0.64 ( 1.04 )
    -0.71 ( 0.94 )
    -0.83 ( 0.82 )
        End-of-stimulation visit
    -0.56 ( 0.96 )
    -0.68 ( 1.15 )
    -0.59 ( 1.00 )
    -0.60 ( 1.01 )
    -0.80 ( 1.02 )
    -0.67 ( 0.86 )
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 6)
    Comparison groups
    FE 999302 (1 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [166]
    P-value
    		 = 0.5027
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.96
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.85
         upper limit
    		 1.08
    Notes
    [166] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 6)
    Comparison groups
    FE 999302 (2 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    205
    Analysis specification
    Pre-specified
    Analysis type
    		 other [167]
    P-value
    		 = 0.6268
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.03
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.92
         upper limit
    		 1.16
    Notes
    [167] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 6)
    Comparison groups
    FE 999302 (4 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [168]
    P-value
    		 = 0.2721
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.95
         upper limit
    		 1.2
    Notes
    [168] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 6)
    Comparison groups
    FE 999302 (8 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    211
    Analysis specification
    Pre-specified
    Analysis type
    		 other [169]
    P-value
    		 = 0.5182
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.04
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.92
         upper limit
    		 1.17
    Notes
    [169] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 6)
    Comparison groups
    FE 999302 (12 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [170]
    P-value
    		 = 0.892
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.99
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.88
         upper limit
    		 1.11
    Notes
    [170] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 8)
    Comparison groups
    FE 999302 (1 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [171]
    P-value
    		 = 0.5371
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.05
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.91
         upper limit
    		 1.2
    Notes
    [171] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 8)
    Comparison groups
    FE 999302 (2 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    205
    Analysis specification
    Pre-specified
    Analysis type
    		 other [172]
    P-value
    		 = 0.0608
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.15
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.99
         upper limit
    		 1.32
    Notes
    [172] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 8)
    Comparison groups
    FE 999302 (4 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [173]
    P-value
    		 = 0.101
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.13
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.98
         upper limit
    		 1.3
    Notes
    [173] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 8)
    Comparison groups
    FE 999302 (8 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    211
    Analysis specification
    Pre-specified
    Analysis type
    		 other [174]
    P-value
    		 = 0.0118
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.2
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 1.04
         upper limit
    		 1.38
    Notes
    [174] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (Stimulation Day 8)
    Comparison groups
    FE 999302 (12 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [175]
    P-value
    		 = 0.1043
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.12
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.98
         upper limit
    		 1.29
    Notes
    [175] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (End-of-stimulation)
    Comparison groups
    FE 999302 (1 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [176]
    P-value
    		 = 0.3746
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.06
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.93
         upper limit
    		 1.21
    Notes
    [176] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (End-of-stimulation)
    Comparison groups
    FE 999302 (2 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    205
    Analysis specification
    Pre-specified
    Analysis type
    		 other [177]
    P-value
    		 = 0.3276
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.93
         upper limit
    		 1.22
    Notes
    [177] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (End-of-stimulation)
    Comparison groups
    FE 999302 (4 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [178]
    P-value
    		 = 0.1474
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.1
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.97
         upper limit
    		 1.26
    Notes
    [178] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (End-of-stimulation)
    Comparison groups
    Placebo and Follitropin Delta v FE 999302 (8 μg) and Follitropin Delta
    Number of subjects included in analysis
    211
    Analysis specification
    Pre-specified
    Analysis type
    		 other [179]
    P-value
    		 = 0.3032
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    1.07
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.94
         upper limit
    		 1.23
    Notes
    [179] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.
    Statistical analysis title
    		 FE 999302, Placebo (End-of-stimulation)
    Comparison groups
    FE 999302 (12 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [180]
    P-value
    		 = 0.4131
    Method
    		 ANCOVA
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.95
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.83
         upper limit
    		 1.08
    Notes
    [180] - Treatment groups were compared using multiplicative ANCOVA model with treatment, age strata, and AMH group as factors, and concentration on stimulation Day 1 as a covariate.

    Secondary: Positive βhCG (positive serum βhCG test 13-15 days after transfer)

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    End point title
    		 Positive βhCG (positive serum βhCG test 13-15 days after transfer)
    End point description
    Positive βhCG rate was defined as positive serum βhCG test 13-15 days after transfer. The analysis population included the FAS which consisted of all subjects who were randomised and started treatment with FE 999302 or placebo. Subjects were analysed according to the treatment they actually received.
    End point type
    Secondary
    End point timeframe
    13-15 days after blastocyst transfer
    End point values
    		 FE 999302 (1 μg) and Follitropin Delta FE 999302 (2 μg) and Follitropin Delta FE 999302 (4 μg) and Follitropin Delta FE 999302 (8 μg) and Follitropin Delta FE 999302 (12 μg) and Follitropin Delta Placebo and Follitropin Delta
    Number of subjects analysed
    104
    101
    99
    107
    104
    104
    Units: Number of positive subjects
        number (not applicable)
    36
    40
    45
    51
    43
    52
    Statistical analysis title
    		 FE 999302, Placebo
    Comparison groups
    Placebo and Follitropin Delta v FE 999302 (1 μg) and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [181]
    P-value
    		 = 0.0264
    Method
    		 Logistic regression model
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.53
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.3
         upper limit
    		 0.93
    Notes
    [181] - Logistic regression model with treatment, age strata, and AMH group as factors.
    Statistical analysis title
    		 FE 999302, Placebo
    Comparison groups
    FE 999302 (2 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    205
    Analysis specification
    Pre-specified
    Analysis type
    		 other [182]
    P-value
    		 = 0.1293
    Method
    		 Logistic regression model
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.65
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.37
         upper limit
    		 1.13
    Notes
    [182] - Logistic regression model with treatment, age strata, and AMH group as factors.
    Statistical analysis title
    		 FE 999302, Placebo
    Comparison groups
    FE 999302 (4 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [183]
    P-value
    		 = 0.5392
    Method
    		 Logistic regression model
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.48
         upper limit
    		 1.47
    Notes
    [183] - Logistic regression model with treatment, age strata, and AMH group as factors.
    Statistical analysis title
    		 FE 999302, Placebo
    Comparison groups
    FE 999302 (8 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    211
    Analysis specification
    Pre-specified
    Analysis type
    		 other [184]
    P-value
    		 = 0.7899
    Method
    		 Logistic regression model
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.54
         upper limit
    		 1.6
    Notes
    [184] - Logistic regression model with treatment, age strata, and AMH group as factors.
    Statistical analysis title
    		 FE 999302, Placebo
    Comparison groups
    FE 999302 (12 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [185]
    P-value
    		 = 0.2208
    Method
    		 Logistic regression model
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.71
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.41
         upper limit
    		 1.23
    Notes
    [185] - Logistic regression model with treatment, age strata, and AMH group as factors.

    Secondary: Clinical pregnancy (at least one gestational sac 5-6 weeks after transfer)

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    End point title
    		 Clinical pregnancy (at least one gestational sac 5-6 weeks after transfer)
    End point description
    Clinical pregnancy was defined as at least one gestational sac 5-6 weeks after transfer. The analysis population included the FAS which consisted of all subjects who were randomised and started treatment with FE 999302 or placebo. Subjects were analysed according to the treatment they actually received.
    End point type
    Secondary
    End point timeframe
    5-6 weeks after blastocyst transfer
    End point values
    		 FE 999302 (1 μg) and Follitropin Delta FE 999302 (2 μg) and Follitropin Delta FE 999302 (4 μg) and Follitropin Delta FE 999302 (8 μg) and Follitropin Delta FE 999302 (12 μg) and Follitropin Delta Placebo and Follitropin Delta
    Number of subjects analysed
    104
    101
    99
    107
    104
    104
    Units: Number of positive subjects
        number (not applicable)
    32
    34
    44
    48
    40
    51
    Statistical analysis title
    		 FE 999302, Placebo
    Comparison groups
    FE 999302 (1 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [186]
    P-value
    		 = 0.0081
    Method
    		 Logistic regression model
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.46
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.26
         upper limit
    		 0.82
    Notes
    [186] - Logistic regression model with treatment, age strata, and AMH group as factors.
    Statistical analysis title
    		 FE 999302, Placebo
    Comparison groups
    FE 999302 (2 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    205
    Analysis specification
    Pre-specified
    Analysis type
    		 other [187]
    P-value
    		 = 0.0242
    Method
    		 Logistic regression model
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.52
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.29
         upper limit
    		 0.92
    Notes
    [187] - Logistic regression model with treatment, age strata, and AMH group as factors.
    Statistical analysis title
    		 FE 999302, Placebo
    Comparison groups
    FE 999302 (4 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [188]
    P-value
    		 = 0.5407
    Method
    		 Logistic regression model
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.48
         upper limit
    		 1.47
    Notes
    [188] - Logistic regression model with treatment, age strata, and AMH group as factors.
    Statistical analysis title
    		 FE 999302, Placebo
    Comparison groups
    FE 999302 (8 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    211
    Analysis specification
    Pre-specified
    Analysis type
    		 other [189]
    P-value
    		 = 0.5971
    Method
    		 Logistic regression model
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.5
         upper limit
    		 1.49
    Notes
    [189] - Logistic regression model with treatment, age strata, and AMH group as factors.
    Statistical analysis title
    		 FE 999302, Placebo
    Comparison groups
    FE 999302 (12 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [190]
    P-value
    		 = 0.1325
    Method
    		 Logistic regression model
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.65
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.37
         upper limit
    		 1.14
    Notes
    [190] - Logistic regression model with treatment, age strata, and AMH group as factors.

    Secondary: Vital pregnancy (at least one intrauterine gestational sac with fetal heart beat 5-6 weeks after transfer)

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    End point title
    		 Vital pregnancy (at least one intrauterine gestational sac with fetal heart beat 5-6 weeks after transfer)
    End point description
    Vital pregnancy was defined at least one intrauterine gestational sac with fetal heart beat 5-6 weeks after transfer. The analysis population included the FAS which consisted of all subjects who were randomised and started treatment with FE 999302 or placebo. Subjects were analysed according to the treatment they actually received.
    End point type
    Secondary
    End point timeframe
    5-6 weeks after blastocyst transfer
    End point values
    		 FE 999302 (1 μg) and Follitropin Delta FE 999302 (2 μg) and Follitropin Delta FE 999302 (4 μg) and Follitropin Delta FE 999302 (8 μg) and Follitropin Delta FE 999302 (12 μg) and Follitropin Delta Placebo and Follitropin Delta
    Number of subjects analysed
    104
    101
    99
    107
    104
    104
    Units: Number of positive subjects
        number (not applicable)
    30
    31
    41
    43
    37
    45
    Statistical analysis title
    		 FE 999302, Placebo
    Comparison groups
    FE 999302 (1 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [191]
    P-value
    		 = 0.031
    Method
    		 Logistic regression model
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.53
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.3
         upper limit
    		 0.94
    Notes
    [191] - Logistic regression model with treatment, age strata, and AMH group as factors.
    Statistical analysis title
    		 FE 999302, Placebo
    Comparison groups
    FE 999302 (2 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    205
    Analysis specification
    Pre-specified
    Analysis type
    		 other [192]
    P-value
    		 = 0.0589
    Method
    		 Logistic regression model
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.57
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.32
         upper limit
    		 1.02
    Notes
    [192] - Logistic regression model with treatment, age strata, and AMH group as factors.
    Statistical analysis title
    		 FE 999302, Placebo
    Comparison groups
    FE 999302 (4 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [193]
    P-value
    		 = 0.8116
    Method
    		 Logistic regression model
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.93
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.53
         upper limit
    		 1.64
    Notes
    [193] - Logistic regression model with treatment, age strata, and AMH group as factors.
    Statistical analysis title
    		 FE 999302, Placebo
    Comparison groups
    FE 999302 (8 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    211
    Analysis specification
    Pre-specified
    Analysis type
    		 other [194]
    P-value
    		 = 0.7012
    Method
    		 Logistic regression model
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.52
         upper limit
    		 1.56
    Notes
    [194] - Logistic regression model with treatment, age strata, and AMH group as factors.
    Statistical analysis title
    		 FE 999302, Placebo
    Comparison groups
    FE 999302 (12 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [195]
    P-value
    		 = 0.2665
    Method
    		 Logistic regression model
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.73
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.41
         upper limit
    		 1.28
    Notes
    [195] - Logistic regression model with treatment, age strata, and AMH group as factors.

    Secondary: Ongoing pregnancy (at least one intrauterine viable fetus 10-11 weeks after transfer)

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    End point title
    		 Ongoing pregnancy (at least one intrauterine viable fetus 10-11 weeks after transfer)
    End point description
    Ongoing pregnancy was defined as at least one intrauterine viable fetus 10-11 weeks after transfer. The analysis population included the FAS which consisted of all subjects who were randomised and started treatment with FE 999302 or placebo. Subjects were analysed according to the treatment they actually received.
    End point type
    Secondary
    End point timeframe
    10-11 weeks after blastocyst transfer
    End point values
    		 FE 999302 (1 μg) and Follitropin Delta FE 999302 (2 μg) and Follitropin Delta FE 999302 (4 μg) and Follitropin Delta FE 999302 (8 μg) and Follitropin Delta FE 999302 (12 μg) and Follitropin Delta Placebo and Follitropin Delta
    Number of subjects analysed
    104
    101
    99
    107
    104
    104
    Units: Number of positive subjects
        number (not applicable)
    30
    30
    39
    40
    32
    45
    Statistical analysis title
    		 FE 999302, Placebo
    Comparison groups
    FE 999302 (1 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [196]
    P-value
    		 = 0.0307
    Method
    		 Logistic regression model
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.53
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.29
         upper limit
    		 0.94
    Notes
    [196] - Logistic regression model with treatment, age strata, and AMH group as factors.
    Statistical analysis title
    		 FE 999302, Placebo
    Comparison groups
    FE 999302 (2 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    205
    Analysis specification
    Pre-specified
    Analysis type
    		 other [197]
    P-value
    		 = 0.041
    Method
    		 Logistic regression model
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.54
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.3
         upper limit
    		 0.98
    Notes
    [197] - Logistic regression model with treatment, age strata, and AMH group as factors.
    Statistical analysis title
    		 FE 999302, Placebo
    Comparison groups
    FE 999302 (4 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [198]
    P-value
    		 = 0.5934
    Method
    		 Logistic regression model
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.49
         upper limit
    		 1.51
    Notes
    [198] - Logistic regression model with treatment, age strata, and AMH group as factors.
    Statistical analysis title
    		 FE 999302, Placebo
    Comparison groups
    FE 999302 (8 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    211
    Analysis specification
    Pre-specified
    Analysis type
    		 other [199]
    P-value
    		 = 0.4221
    Method
    		 Logistic regression model
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.46
         upper limit
    		 1.39
    Notes
    [199] - Logistic regression model with treatment, age strata, and AMH group as factors.
    Statistical analysis title
    		 FE 999302, Placebo
    Comparison groups
    FE 999302 (12 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [200]
    P-value
    		 = 0.065
    Method
    		 Logistic regression model
    Parameter type
    		 Odds ratio (OR)
    Point estimate
    0.58
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.33
         upper limit
    		 1.03
    Notes
    [200] - Logistic regression model with treatment, age strata, and AMH group as factors.

    Secondary: Number of oocytes retrieved

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    End point title
    		 Number of oocytes retrieved
    End point description
    The number of oocytes retrieved was recorded at the oocyte retrieval visit.
    End point type
    Secondary
    End point timeframe
    Day of oocyte retrieval
    End point values
    		 FE 999302 (1 μg) and Follitropin Delta FE 999302 (2 μg) and Follitropin Delta FE 999302 (4 μg) and Follitropin Delta FE 999302 (8 μg) and Follitropin Delta FE 999302 (12 μg) and Follitropin Delta Placebo and Follitropin Delta
    Number of subjects analysed
    104
    101
    99
    107
    104
    104
    Units: Number of oocytes retrieved
        arithmetic mean (standard deviation)
    10.9 ( 4.8 )
    10.8 ( 5.6 )
    10.8 ( 5.2 )
    11.3 ( 4.9 )
    9.8 ( 4.9 )
    12.5 ( 6.4 )
    Statistical analysis title
    		 FE 999302, Placebo
    Comparison groups
    FE 999302 (1 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [201]
    P-value
    		 = 0.0075
    Method
    		 Negative binomial regression model
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.75
         upper limit
    		 0.96
    Notes
    [201] - Treatment groups were compared using a negative binomial regression model with treatment, age strata, and AMH group as factors.
    Statistical analysis title
    		 FE 999302, Placebo
    Comparison groups
    FE 999302 (2 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    205
    Analysis specification
    Pre-specified
    Analysis type
    		 other [202]
    P-value
    		 = 0.013
    Method
    		 Negative binomial regression model
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.75
         upper limit
    		 0.97
    Notes
    [202] - Treatment groups were compared using a negative binomial regression model with treatment, age strata, and AMH group as factors.
    Statistical analysis title
    		 FE 999302, Placebo
    Comparison groups
    FE 999302 (4 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [203]
    P-value
    		 = 0.0081
    Method
    		 Negative binomial regression model
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.84
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.74
         upper limit
    		 0.96
    Notes
    [203] - Treatment groups were compared using a negative binomial regression model with treatment, age strata, and AMH group as factors.
    Statistical analysis title
    		 FE 999302, Placebo
    Comparison groups
    FE 999302 (8 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    211
    Analysis specification
    Pre-specified
    Analysis type
    		 other [204]
    P-value
    		 = 0.091
    Method
    		 Negative binomial regression model
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.9
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.8
         upper limit
    		 1.02
    Notes
    [204] - Treatment groups were compared using a negative binomial regression model with treatment, age strata, and AMH group as factors.
    Statistical analysis title
    		 FE 999302, Placebo
    Comparison groups
    FE 999302 (12 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [205]
    P-value
    		 < 0.0001
    Method
    		 Negative binomial regression model
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.78
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.69
         upper limit
    		 0.88
    Notes
    [205] - Treatment groups were compared using a negative binomial regression model with treatment, age strata, and AMH group as factors.

    Secondary: Number of metaphase II oocytes

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    End point title
    		 Number of metaphase II oocytes
    End point description
    Number of oocytes in metaphase II prior to intracytoplasmic sperm injection (ICSI) insemination. The analysis population included the FAS which consisted of all subjects who were randomised and started treatment with FE 999302 or placebo. Subjects were analysed according to the treatment they actually received.
    End point type
    Secondary
    End point timeframe
    Prior to insemination
    End point values
    		 FE 999302 (1 μg) and Follitropin Delta FE 999302 (2 μg) and Follitropin Delta FE 999302 (4 μg) and Follitropin Delta FE 999302 (8 μg) and Follitropin Delta FE 999302 (12 μg) and Follitropin Delta Placebo and Follitropin Delta
    Number of subjects analysed
    104
    101
    99
    107
    104
    104
    Units: Number of oocytes
        arithmetic mean (standard deviation)
    8.5 ( 4.0 )
    8.4 ( 4.9 )
    8.2 ( 4.5 )
    8.5 ( 4.3 )
    7.4 ( 4.2 )
    9.7 ( 5.2 )
    Statistical analysis title
    		 FE 999302, Placebo
    Comparison groups
    FE 999302 (1 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [206]
    P-value
    		 = 0.0203
    Method
    		 Negative binomial regression model
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.85
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.74
         upper limit
    		 0.97
    Notes
    [206] - Treatment groups were compared using a negative binomial regression model with treatment, age strata, and AMH group as factors.
    Statistical analysis title
    		 FE 999302, Placebo
    Comparison groups
    FE 999302 (2 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    205
    Analysis specification
    Pre-specified
    Analysis type
    		 other [207]
    P-value
    		 = 0.0269
    Method
    		 Negative binomial regression model
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.86
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.74
         upper limit
    		 0.98
    Notes
    [207] - Treatment groups were compared using a Negative binomial regression model with treatment, age strata, and AMH group as factors.
    Statistical analysis title
    		 FE 999302, Placebo
    Comparison groups
    FE 999302 (4 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [208]
    P-value
    		 = 0.0078
    Method
    		 Negative binomial regression model
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.83
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.72
         upper limit
    		 0.95
    Notes
    [208] - Treatment groups were compared using a Negative binomial regression model with treatment, age strata, and AMH group as factors.
    Statistical analysis title
    		 FE 999302, Placebo
    Comparison groups
    FE 999302 (8 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    211
    Analysis specification
    Pre-specified
    Analysis type
    		 other [209]
    P-value
    		 = 0.044
    Method
    		 Negative binomial regression model
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.87
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.76
         upper limit
    		 1
    Notes
    [209] - Treatment groups were compared using a Negative binomial regression model with treatment, age strata, and AMH group as factors.
    Statistical analysis title
    		 FE 999302, Placebo
    Comparison groups
    FE 999302 (12 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [210]
    P-value
    		 < 0.0001
    Method
    		 Negative binomial regression model
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.65
         upper limit
    		 0.86
    Notes
    [210] - Treatment groups were compared using a Negative binomial regression model with treatment, age strata, and AMH group as factors.

    Secondary: Number of fertilised (2 pronuclei [PN]) oocytes

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    End point title
    		 Number of fertilised (2 pronuclei [PN]) oocytes
    End point description
    The number of pronuclei was counted on day 1 after insemination and recorded as 0, 1, 2, or >2. Fertilised oocytes with 2PN were regarded as correctly fertilised. The analysis population included the FAS which consisted of all subjects who were randomised and started treatment with FE 999302 or placebo. Subjects were analysed according to the treatment they actually received.
    End point type
    Secondary
    End point timeframe
    On Day 1 after insemination
    End point values
    		 FE 999302 (1 μg) and Follitropin Delta FE 999302 (2 μg) and Follitropin Delta FE 999302 (4 μg) and Follitropin Delta FE 999302 (8 μg) and Follitropin Delta FE 999302 (12 μg) and Follitropin Delta Placebo and Follitropin Delta
    Number of subjects analysed
    104
    101
    99
    107
    104
    104
    Units: Number of oocytes
        arithmetic mean (standard deviation)
    6.2 ( 3.6 )
    6.2 ( 3.9 )
    5.7 ( 3.7 )
    6.0 ( 3.6 )
    5.2 ( 3.7 )
    7.4 ( 4.2 )
    Statistical analysis title
    		 FE 999302, Placebo
    Comparison groups
    FE 999302 (1 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [211]
    P-value
    		 = 0.0104
    Method
    		 Negative binomial regression model
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.81
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.69
         upper limit
    		 0.95
    Notes
    [211] - Treatment groups were compared using a negative binomial regression model with treatment, age strata, and AMH group as factors.
    Statistical analysis title
    		 FE 999302, Placebo
    Comparison groups
    FE 999302 (2 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    205
    Analysis specification
    Pre-specified
    Analysis type
    		 other [212]
    P-value
    		 = 0.0209
    Method
    		 Negative binomial regression model
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.82
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 0.97
    Notes
    [212] - Treatment groups were compared using a negative binomial regression model with treatment, age strata, and AMH group as factors.
    Statistical analysis title
    		 FE 999302, Placebo
    Comparison groups
    FE 999302 (4 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    203
    Analysis specification
    Pre-specified
    Analysis type
    		 other [213]
    P-value
    		 = 0.0006
    Method
    		 Negative binomial regression model
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.75
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.63
         upper limit
    		 0.88
    Notes
    [213] - Treatment groups were compared using a negative binomial regression model with treatment, age strata, and AMH group as factors.
    Statistical analysis title
    		 FE 999302, Placebo
    Comparison groups
    FE 999302 (8 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    211
    Analysis specification
    Pre-specified
    Analysis type
    		 other [214]
    P-value
    		 = 0.0069
    Method
    		 Negative binomial regression model
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.8
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.68
         upper limit
    		 0.94
    Notes
    [214] - Treatment groups were compared using a negative binomial regression model with treatment, age strata, and AMH group as factors.
    Statistical analysis title
    		 FE 999302, Placebo
    Comparison groups
    FE 999302 (12 μg) and Follitropin Delta v Placebo and Follitropin Delta
    Number of subjects included in analysis
    208
    Analysis specification
    Pre-specified
    Analysis type
    		 other [215]
    P-value
    		 < 0.0001
    Method
    		 Negative binomial regression model
    Parameter type
    		 Ratio vs Placebo
    Point estimate
    0.69
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.58
         upper limit
    		 0.82
    Notes
    [215] - Treatment groups were compared using a negative binomial regression model with treatment, age strata, and AMH group as factors.

    Secondary: Incidence of ovarian hyperstimulation syndrome (OHSS) (early or late, any grade)

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    End point title
    		 Incidence of ovarian hyperstimulation syndrome (OHSS) (early or late, any grade)
    End point description
    Early OHSS was defined as OHSS with onset ≤9 days after triggering of final follicular maturation (including OHSS with onset before triggering and OHSS with onset during stimulation where triggering was not performed). Late OHSS was defined as OHSS with onset >9 days after triggering of final follicular maturation. The safety analysis set was identical to the FAS (including allocation to treatment). The FAS consisted of all subjects who were randomised and started treatment with FE 999302 or placebo. Subjects were analysed according to the treatment they actually received.
    End point type
    Secondary
    End point timeframe
    From stimulation Day 1 to end-of-trial
    End point values
    		 FE 999302 (1 μg) and Follitropin Delta FE 999302 (2 μg) and Follitropin Delta FE 999302 (4 μg) and Follitropin Delta FE 999302 (8 μg) and Follitropin Delta FE 999302 (12 μg) and Follitropin Delta Placebo and Follitropin Delta
    Number of subjects analysed
    104
    101
    99
    107
    104
    104
    Units: Number of subjects
    number (not applicable)
        All OHSS (Any grade)
    6
    2
    6
    11
    4
    12
        All early OHSS (Any grade)
    3
    2
    4
    7
    3
    6
        All late OHSS (Any grade)
    3
    0
    2
    4
    1
    6
    No statistical analyses for this end point

    Secondary: Incidence and intensity of adverse events

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    End point title
    		 Incidence and intensity of adverse events
    End point description
    The adverse events (AEs) occurring after start of IMP and before the end-of-trial visit, or a pre-treatment AE or pre-existing medical condition that worsens in intensity after start of FE 999302 or placebo treatment and before the end-of-trial visit were considered treatment-emergent AEs and are presented for this endpoint. Intensity of AEs was classified as mild, moderate or severe and is also presented for this endpoint. The safety analysis set was identical to the FAS (including allocation to treatment). The FAS consisted of all subjects who were randomised and started treatment with FE 999302 or placebo. Subjects were analysed according to the treatment they actually received.
    End point type
    Secondary
    End point timeframe
    From screening to end-of-trial (estimated maximum of 4 months from start of stimulation)
    End point values
    		 FE 999302 (1 μg) and Follitropin Delta FE 999302 (2 μg) and Follitropin Delta FE 999302 (4 μg) and Follitropin Delta FE 999302 (8 μg) and Follitropin Delta FE 999302 (12 μg) and Follitropin Delta Placebo and Follitropin Delta
    Number of subjects analysed
    104
    101
    99
    107
    104
    104
    Units: Number of subjects
    number (not applicable)
        All AEs
    47
    40
    48
    56
    44
    50
        Mild AEs
    40
    33
    37
    45
    37
    38
        Moderate AEs
    17
    9
    16
    14
    12
    17
        Severe AEs
    0
    5
    1
    3
    1
    5
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    The AEs were recorded from From screening to end-of-trial
    Adverse event reporting additional description
    Adverse events occurring after start of IMP and before the end-of-trial visit, or a pre-treatment AE or pre-existing medical condition that worsens in intensity after start of FE 999302 or placebo treatment and before the end-of-trial visit (treatment-emergent AEs) are presented for the safety analysis set.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    21.0
    Reporting groups
    Reporting group title
    FE 999302 (1 μg) and Follitropin Delta
    Reporting group description
    		 Dose 1 μg of FE 999302, a rhCG solution for subcutaneous injection; individualised follitropin delta dose

    Reporting group title
    FE 999302 (2 μg) and Follitropin Delta
    Reporting group description
    		 Dose 2 μg of FE 999302, a rhCG solution for subcutaneous injection; individualised follitropin delta dose

    Reporting group title
    FE 999302 (4 μg) and Follitropin Delta
    Reporting group description
    		 Dose 4 μg of FE 999302, a rhCG solution for subcutaneous injection; individualised follitropin delta dose

    Reporting group title
    FE 999302 (8 μg) and Follitropin Delta
    Reporting group description
    		 Dose 8 μg of FE 999302, a rhCG solution for subcutaneous injection; individualised follitropin delta dose

    Reporting group title
    FE 999302 (12 μg) and Follitropin Delta
    Reporting group description
    		 Dose 12 μg of FE 999302, a rhCG solution for subcutaneous injection; individualised follitropin delta dose

    Reporting group title
    Placebo and Follitropin Delta
    Reporting group description
    		 Placebo and individualised follitropin delta dose

    Serious adverse events
    		 FE 999302 (1 μg) and Follitropin Delta FE 999302 (2 μg) and Follitropin Delta FE 999302 (4 μg) and Follitropin Delta FE 999302 (8 μg) and Follitropin Delta FE 999302 (12 μg) and Follitropin Delta Placebo and Follitropin Delta
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 104 (0.96%)
    1 / 101 (0.99%)
    1 / 99 (1.01%)
    3 / 107 (2.80%)
    2 / 104 (1.92%)
    3 / 104 (2.88%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    Injury, poisoning and procedural complications
    Post procedural haemorrhage
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 101 (0.00%)
    0 / 99 (0.00%)
    1 / 107 (0.93%)
    0 / 104 (0.00%)
    0 / 104 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 101 (0.00%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
    1 / 104 (0.96%)
    0 / 104 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Abortion threatened
         subjects affected / exposed
    1 / 104 (0.96%)
    0 / 101 (0.00%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
    0 / 104 (0.00%)
    0 / 104 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Vomiting in pregnancy
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 101 (0.00%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
    0 / 104 (0.00%)
    1 / 104 (0.96%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Reproductive system and breast disorders
    Ovarian hyperstimulation syndrome
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 101 (0.00%)
    1 / 99 (1.01%)
    1 / 107 (0.93%)
    1 / 104 (0.96%)
    2 / 104 (1.92%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    1 / 1
    1 / 1
    1 / 1
    1 / 2
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Adnexal torsion
         subjects affected / exposed
    0 / 104 (0.00%)
    0 / 101 (0.00%)
    0 / 99 (0.00%)
    1 / 107 (0.93%)
    0 / 104 (0.00%)
    0 / 104 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 1
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Ovarian cyst
         subjects affected / exposed
    0 / 104 (0.00%)
    1 / 101 (0.99%)
    0 / 99 (0.00%)
    0 / 107 (0.00%)
    0 / 104 (0.00%)
    0 / 104 (0.00%)
         occurrences causally related to treatment / all
    0 / 0
    1 / 1
    0 / 0
    0 / 0
    0 / 0
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 FE 999302 (1 μg) and Follitropin Delta FE 999302 (2 μg) and Follitropin Delta FE 999302 (4 μg) and Follitropin Delta FE 999302 (8 μg) and Follitropin Delta FE 999302 (12 μg) and Follitropin Delta Placebo and Follitropin Delta
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    28 / 104 (26.92%)
    19 / 101 (18.81%)
    32 / 99 (32.32%)
    38 / 107 (35.51%)
    30 / 104 (28.85%)
    34 / 104 (32.69%)
    Injury, poisoning and procedural complications
    Procedural pain
         subjects affected / exposed
    1 / 104 (0.96%)
    2 / 101 (1.98%)
    4 / 99 (4.04%)
    4 / 107 (3.74%)
    2 / 104 (1.92%)
    7 / 104 (6.73%)
         occurrences all number
    1
    2
    4
    4
    2
    7
    Nervous system disorders
    Headache
         subjects affected / exposed
    11 / 104 (10.58%)
    8 / 101 (7.92%)
    13 / 99 (13.13%)
    18 / 107 (16.82%)
    15 / 104 (14.42%)
    11 / 104 (10.58%)
         occurrences all number
    12
    9
    13
    22
    17
    13
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
         subjects affected / exposed
    1 / 104 (0.96%)
    2 / 101 (1.98%)
    5 / 99 (5.05%)
    6 / 107 (5.61%)
    5 / 104 (4.81%)
    3 / 104 (2.88%)
         occurrences all number
    1
    2
    5
    6
    5
    3
    Biochemical pregnancy
         subjects affected / exposed
    4 / 104 (3.85%)
    6 / 101 (5.94%)
    1 / 99 (1.01%)
    3 / 107 (2.80%)
    3 / 104 (2.88%)
    5 / 104 (4.81%)
         occurrences all number
    4
    6
    1
    3
    3
    5
    Reproductive system and breast disorders
    Ovarian hyperstimulation syndrome
         subjects affected / exposed
    6 / 104 (5.77%)
    2 / 101 (1.98%)
    5 / 99 (5.05%)
    10 / 107 (9.35%)
    3 / 104 (2.88%)
    10 / 104 (9.62%)
         occurrences all number
    6
    2
    5
    10
    3
    10
    Gastrointestinal disorders
    Nausea
         subjects affected / exposed
    2 / 104 (1.92%)
    0 / 101 (0.00%)
    6 / 99 (6.06%)
    7 / 107 (6.54%)
    3 / 104 (2.88%)
    2 / 104 (1.92%)
         occurrences all number
    3
    0
    6
    7
    3
    2
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    6 / 104 (5.77%)
    1 / 101 (0.99%)
    3 / 99 (3.03%)
    2 / 107 (1.87%)
    3 / 104 (2.88%)
    1 / 104 (0.96%)
         occurrences all number
    6
    1
    3
    3
    3
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Mar 2020
    Amendment 04 (version 1.0, dated 19 March 2020) was a substantial amendment issued as urgent safety measures due to COVID-19 required to protect subjects against immediate hazard to their health and safety. The amendment included guidance for continued trial conduct and management of subjects included in the trial.

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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