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    Clinical Trial Results:
    Analysis of follicular steroid synthesis during controlled ovarian stimulation with recombinant FSH vs HMG in GnRH antagonist cycles

    Summary
    EudraCT number
    		 2015-005762-28
    Trial protocol
    		 ES  
    Global end of trial date
    15 Jun 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Nov 2021
    First version publication date
    14 Nov 2021
    Other versions
    Summary report(s)
    		 1512-VLC-066-EB-RESULTS

    Trial information

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    Trial identification
    Sponsor protocol code
    1512-VLC-066-EB
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02738580
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    IVI
    Sponsor organisation address
    PLAZA POLICIA LOCAL 1, VALENCIA, Spain,
    Public contact
    Ernesto Bosch, IVI Valencia, Ernesto.Bosch@ivirma.com
    Scientific contact
    Ernesto Bosch, IVI Valencia, Ernesto.Bosch@ivi.es
    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
    Final
    Date of interim/final analysis
    15 Jun 2018
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    15 Jun 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare serum concentrations of the different hormones involved in follicular steroid genesis during a cycle of controlled ovarian stimulation with recombinant FSH or HMG
    Protection of trial subjects
    Not aplicable.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Mar 2016
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Spain: 112
    Worldwide total number of subjects
    112
    EEA total number of subjects
    112
    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)
    112
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 114 were evaluated for selecction. 112 patient were included. 104 patients were completed.

    Pre-assignment
    Screening details
    		 112 were evaluated for selecction. 56 were randomized to hpHMG group: - Cycle Cancelled due to low response: 2 - Voluntary withdrawal from trial: 1 - Excluded from the donation programme: 1 56 were randomized to rFSH - Cycle cancelled due to low response: 3 - Cycle cancelled due to SAE: 1 104 patients were completed.

    Period 1
    Period 1 title
    OVERAL TRIAL (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 rFSH
    Arm description
    		 Oocyte donor with normal ovarian function, who will follow ovarian stimulation in cycle with GnRH Antagonists and rFSH.
    Arm type
    		 Experimental

    Investigational medicinal product name
    recombinant FSH
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    as usual clinical practice

    Arm title
    		 HP-hmg
    Arm description
    		 Oocyte donor with normal ovarian function, who will follow ovarian stimulation in cycle with GnRH Antagonists and HP-HMG.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    HP-HMG
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    AS CLINICAL PRACTICE

    Number of subjects in period 1
    		rFSH HP-hmg
    Started
    56
    56
    Completed
    52
    52
    Not completed
    4
    4
         Adverse event, non-fatal
    1
    -
         WITHDRAWAL CONSENT
    -
    1
         EXCLUDED FROM DONNOR PROGRAM
    -
    1
         Lack of efficacy
    3
    2

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    rFSH
    Reporting group description
    		 Oocyte donor with normal ovarian function, who will follow ovarian stimulation in cycle with GnRH Antagonists and rFSH.

    Reporting group title
    HP-hmg
    Reporting group description
    		 Oocyte donor with normal ovarian function, who will follow ovarian stimulation in cycle with GnRH Antagonists and HP-HMG.

    Primary: SERUM PROGESTERONE CONCENTRATION

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    End point title
    		 SERUM PROGESTERONE CONCENTRATION
    End point description
    COMPARE HORMONAL BLOOD SERUM CONCENTRATIONS OF PROGESTERONE DURING OVARIAN STIMULATION IMPLIED IN FOLLICULAR STEROIDOGENESIS DURING A CYCLE OF CONTROLLED OVARIAN STIMULATION WITH EITHER r-FSH OR HP-HMG
    End point type
    Primary
    End point timeframe
    overal study
    End point values
    		 rFSH HP-hmg
    Number of subjects analysed
    52
    52
    Units: ng/mL
        arithmetic mean (confidence interval 95%)
    0.74 (0.22 to 1.26)
    0.45 (0.19 to 0.71)
    Statistical analysis title
    		 SERUM PROGESTERONE LEVELS
    Comparison groups
    rFSH v HP-hmg
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority [1]
    P-value
    		 ≤ 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Median difference (final values)
    Point estimate
    0.29
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 0.19
         upper limit
    		 1.26
    Variability estimate
    Standard deviation
    Dispersion value
    0.26
    Notes
    [1] - THE PROPORTION OF PATIENTS WITH ELEVATED PROGESTERONE ON LAST DAY OF STIMULATION WAS COMPARED BETWEEN BORTH GROUPS USING THE CHI-SQUERE TEST

    Primary: OVARIAN RESPONSE

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    End point title
    		 OVARIAN RESPONSE
    End point description
    NUMBER OF FOLICLES REACHED AND PUNCTURED AFTER CONTROLED OVARIAN STIMULATION
    End point type
    Primary
    End point timeframe
    OVERAL STUDY
    End point values
    		 rFSH HP-hmg
    Number of subjects analysed
    52
    52
    Units: NUMBER OF FOLICLES
        number (confidence interval 95%)
    16.5 (9 to 24)
    17.5 (9.6 to 25.4)
    Statistical analysis title
    		 OVARIAN RESPONSE
    Statistical analysis description
    NUMBER OF FOLICLES REACHED AND PUNCTURED AFTER CONTROLED OVARIAN STIMULATION
    Comparison groups
    rFSH v HP-hmg
    Number of subjects included in analysis
    104
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.49
    Method
    		 t-test, 1-sided
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    21 DAYS
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23
    Reporting groups
    Reporting group title
    r-FSH
    Reporting group description
    		 -

    Notes
    [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported.
    Justification: No AE has been reported.
    Serious adverse events
    		 r-FSH
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 52 (1.92%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Blood and lymphatic system disorders
    Coagulation test abnormal
    Additional description: VITAMIN K DEFICIENCY SHOWED AS COAGULATION PANEL ALTERATON. PT: 15,4 seg; INR: 1,3; Quick Index: 69%; TTPA: 38 seg. Hemmatic parameters at minimum normal limits She was reffered to hemathologist department. There was not more information about
         subjects affected / exposed
    1 / 52 (1.92%)
         occurrences causally related to treatment / all
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 r-FSH
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 52 (0.00%)

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    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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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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