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    Clinical Trial Results:
    A Multi-Centre, Two-Arm, Interventional, Phase IV Study to Evaluate Tailoring of Recombinant FSH Treatment in Subjects With Chronic Anovulation Using the Gonal-f® Prefilled Pen in Women Undergoing Ovulation Induction

    Summary
    EudraCT number
    		 2012-003227-38
    Trial protocol
    		 GB   IE  
    Global end of trial date
    23 Jul 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    28 Jul 2016
    First version publication date
    28 Jul 2016
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    EMR700623_535
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01871532
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Merck KGaA
    Sponsor organisation address
    Frankfurter Strasse 250, Darmstadt, Germany, 64293
    Public contact
    Communication Centre Merck KGaA, Merck KGaA, +49 6151725200, service@merckgroup.com
    Scientific contact
    Communication Centre Merck KGaA, Merck KGaA, +49 6151725200, service@merckgroup.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
    Final
    Date of interim/final analysis
    25 Mar 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Jul 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The main objective of the trial was to investigate tailoring of recombinant follicle stimulating hormone (rFSH) treatment in subjects with chronic anovulation using 2 low dose protocols, by determining the proportion of cycles with monofollicular development.
    Protection of trial subjects
    Subject protection was ensured by following high medical and ethical standards in accordance with the principles laid down in the Declaration of Helsinki, and that are consistent with Good Clinical Practice and applicable regulations.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Jul 2013
    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
    Ireland: 4
    Country: Number of subjects enrolled
    United Kingdom: 20
    Worldwide total number of subjects
    24
    EEA total number of subjects
    24
    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)
    24
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study was conducted at 8 centres in Ireland and United Kingdom.

    Pre-assignment
    Screening details
    		 A total of 24 subjects were enrolled in the study. Out of 24 only 21 subjects completed the study; 2 subjects discontinued due to hyper-response and 1 subject as per investigator's decision.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Low Dose Gonal-f
    Arm description
    		 Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Gonal-f
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Gonal-f at a starting dose of 50 IU was administered subcutaneously up to maximum dose of 125 IU.

    Investigational medicinal product name
    Human chorionic gonadotropin (hCG)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Human chorionic gonadotropin (hCG) 250 microgram (mcg) was administered subcutaneously.

    Arm title
    		 Standard Low Dose Gonal-f
    Arm description
    		 Gonal-f was administered subcutaneously daily at a starting dose of 50 IU for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Human chorionic gonadotropin (hCG)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Human chorionic gonadotropin (hCG) 250 mcg was administered subcutaneously.

    Investigational medicinal product name
    Gonal-f
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Gonal-f at a starting dose of 50 IU was administered subcutaneously up to maximum dose of 75 IU.

    Number of subjects in period 1
    		Low Dose Gonal-f Standard Low Dose Gonal-f
    Started
    12
    12
    Subjects received hCG treatment
    11
    9 [1]
    Completed
    11
    10
    Not completed
    1
    2
         Consent withdrawn by subject
    1
    2
    Notes
    [1] - The number of subjects at this milestone seems inconsistent with the number of subjects in the arm. It is expected that the number of subjects will be greater than, or equal to the number that completed, minus those who left.
    Justification: The number of subjects at this milestone represent the subjects who received treatment and were less than the total subjects in the arm.

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Low Dose Gonal-f
    Reporting group description
    		 Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.

    Reporting group title
    Standard Low Dose Gonal-f
    Reporting group description
    		 Gonal-f was administered subcutaneously daily at a starting dose of 50 IU for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.

    Reporting group values
    		 Low Dose Gonal-f Standard Low Dose Gonal-f Total
    Number of subjects
    		 12 12 24
    Age categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 30.8 ( 2.96 ) 29.5 ( 3.75 ) -
    Gender, Male/Female
    Units: Subjects
        Female
    		 12 12 24
        Male
    		 0 0 0

    End points

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    End points reporting groups
    Reporting group title
    Low Dose Gonal-f
    Reporting group description
    		 Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.

    Reporting group title
    Standard Low Dose Gonal-f
    Reporting group description
    		 Gonal-f was administered subcutaneously daily at a starting dose of 50 IU for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.

    Primary: Percentage of Cycles With Monofollicular Development

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    End point title
    		 Percentage of Cycles With Monofollicular Development [1]
    End point description
    The monofollicular development was defined as the number of cycles with monofollicular development only one Follicle greater than or equal to (>=) 17 millimeter (mm) and no other follicles >=14 mm following up to 4 weeks Gonal-f treatment.
    End point type
    Primary
    End point timeframe
    Baseline up to 4 weeks
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Data not assessed since study was terminated early due to delay in providing additional drug.
    End point values
    		 Low Dose Gonal-f Standard Low Dose Gonal-f
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: percentage of cycles
        number (not applicable)
    Notes
    [2] - Data not assessed since study was terminated early due to delay in providing additional drug.
    [3] - Data not assessed since study was terminated early due to delay in providing additional drug.
    No statistical analyses for this end point

    Secondary: Percentage of Cycles With Bifollicular Development

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    End point title
    		 Percentage of Cycles With Bifollicular Development
    End point description
    The bifollicular development was defined as the number of cycles with bifollicular development of only two follicles greater than or equal to 17 mm.
    End point type
    Secondary
    End point timeframe
    Baseline up to 4 weeks
    End point values
    		 Low Dose Gonal-f Standard Low Dose Gonal-f
    Number of subjects analysed
    0 [4]
    0 [5]
    Units: percentage of cycles
        number (not applicable)
    Notes
    [4] - Data not assessed since study was terminated early due to delay in providing additional drug.
    [5] - Data not assessed since study was terminated early due to delay in providing additional drug.
    No statistical analyses for this end point

    Secondary: Percentage of Cycles with Multifollicular Development

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    End point title
    		 Percentage of Cycles with Multifollicular Development
    End point description
    The multifollicular development was defined as the number of cycles with multifollicular development of three or more follicles >= 14 millimetre.
    End point type
    Secondary
    End point timeframe
    Baseline up to 4 weeks
    End point values
    		 Low Dose Gonal-f Standard Low Dose Gonal-f
    Number of subjects analysed
    0 [6]
    0 [7]
    Units: percentage of cycles
        number (not applicable)
    Notes
    [6] - Data not assessed since study was terminated early due to delay in providing additional drug.
    [7] - Data not assessed since study was terminated early due to delay in providing additional drug.
    No statistical analyses for this end point

    Secondary: Percentage of ovulatory cycles

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    End point title
    		 Percentage of ovulatory cycles
    End point description
    Ovulation was defined as a serum progesterone (P4 ) level >= 10 nanogram per milliliter (ng/mL) or Clinical Pregnancy. Clinical pregnancy was defined as pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It excludes ectopic pregnancy.
    End point type
    Secondary
    End point timeframe
    Baseline up to 42 days post human chorionic gonadotrophin (hCG) administration
    End point values
    		 Low Dose Gonal-f Standard Low Dose Gonal-f
    Number of subjects analysed
    0 [8]
    0 [9]
    Units: percentage of cycles
        number (not applicable)
    Notes
    [8] - Data not assessed since study was terminated early due to delay in providing additional drug.
    [9] - Data not assessed since study was terminated early due to delay in providing additional drug.
    No statistical analyses for this end point

    Secondary: Percentage of Cycles Wherein Human Chorionic Gonadotropin (hCG) was not Administered

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    End point title
    		 Percentage of Cycles Wherein Human Chorionic Gonadotropin (hCG) was not Administered
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline up to 4 weeks
    End point values
    		 Low Dose Gonal-f Standard Low Dose Gonal-f
    Number of subjects analysed
    0 [10]
    0 [11]
    Units: percentage of cycles
        number (not applicable)
    Notes
    [10] - Data not assessed since study was terminated early due to delay in providing additional drug.
    [11] - Data not assessed since study was terminated early due to delay in providing additional drug.
    No statistical analyses for this end point

    Secondary: Percentage of Cycles Resulting in Clinical Pregnancy

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    End point title
    		 Percentage of Cycles Resulting in Clinical Pregnancy
    End point description
    Clinical pregnancy was defined as pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or definitive clinical signs of pregnancy. It excludes ectopic pregnancy.
    End point type
    Secondary
    End point timeframe
    35-42 days post hCG administration
    End point values
    		 Low Dose Gonal-f Standard Low Dose Gonal-f
    Number of subjects analysed
    0 [12]
    0 [13]
    Units: percentage of cycles
        number (not applicable)
    Notes
    [12] - Data not assessed since study was terminated early due to delay in providing additional drug.
    [13] - Data not assessed since study was terminated early due to delay in providing additional drug.
    No statistical analyses for this end point

    Secondary: Number of Multiple Pregnancy

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    End point title
    		 Number of Multiple Pregnancy
    End point description
    Multiple pregnancy is a pregnancy where more than one fetus develops simultaneously in the womb. There are two types of twinning—identical and fraternal. Identical twins represent the splitting of a single fertilized zygote (union of two gametes or male/female sex cells that produce a developing fetus) into two separate individuals.
    End point type
    Secondary
    End point timeframe
    35-42 days post hCG administration
    End point values
    		 Low Dose Gonal-f Standard Low Dose Gonal-f
    Number of subjects analysed
    0 [14]
    0 [15]
    Units: subjects
        number (not applicable)
    Notes
    [14] - Data not assessed since study was terminated early due to delay in providing additional drug.
    [15] - Data not assessed since study was terminated early due to delay in providing additional drug.
    No statistical analyses for this end point

    Secondary: Number of Fetuses

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    End point title
    		 Number of Fetuses
    End point description
    End point type
    Secondary
    End point timeframe
    35-42 days post hCG administration
    End point values
    		 Low Dose Gonal-f Standard Low Dose Gonal-f
    Number of subjects analysed
    0 [16]
    0 [17]
    Units: fetuses
        number (not applicable)
    Notes
    [16] - Data not assessed since study was terminated early due to delay in providing additional drug.
    [17] - Data not assessed since study was terminated early due to delay in providing additional drug.
    No statistical analyses for this end point

    Secondary: Number of Miscarriages After Confirmation of Clinical Pregnancy

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    End point title
    		 Number of Miscarriages After Confirmation of Clinical Pregnancy
    End point description
    Miscarriages were calculated per clinical pregnancy, and clinical pregnancy was defined as pregnancy diagnosed by ultrasonographic visualization of one or more gestational sacs or confirmed by clinical signs of pregnancy. It excludes ectopic pregnancy.
    End point type
    Secondary
    End point timeframe
    35-42 days post hCG administration
    End point values
    		 Low Dose Gonal-f Standard Low Dose Gonal-f
    Number of subjects analysed
    0 [18]
    0 [19]
    Units: subjects
        number (not applicable)
    Notes
    [18] - Data not assessed since study was terminated early due to delay in providing additional drug.
    [19] - Data not assessed since study was terminated early due to delay in providing additional drug.
    No statistical analyses for this end point

    Secondary: Number of Subjects with Ovarian Hyper Stimulation Syndrome (OHSS)

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    End point title
    		 Number of Subjects with Ovarian Hyper Stimulation Syndrome (OHSS)
    End point description
    OHSS was defined as an exaggerated systemic response to ovarian stimulation characterized by a wide spectrum of clinical and laboratory manifestations, classified as mild, moderate or severe according to the degree of abdominal distention, ovarian enlargement and respiratory, hemodynamic and metabolic complications. Safety population included all subjects who were randomised and received at least 1 Gonal-f injection. Here "99999" signifies data was not evaluable for this outcome measure.
    End point type
    Secondary
    End point timeframe
    Up to 42 days post hCG administration
    End point values
    		 Low Dose Gonal-f Standard Low Dose Gonal-f
    Number of subjects analysed
    12
    12
    Units: subjects
        number (not applicable)
    0
    0
    No statistical analyses for this end point

    Secondary: Duration of Recombinant Follicle Stimulating Hormone (rFSH) Stimulation

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    End point title
    		 Duration of Recombinant Follicle Stimulating Hormone (rFSH) Stimulation
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline up to 4 weeks
    End point values
    		 Low Dose Gonal-f Standard Low Dose Gonal-f
    Number of subjects analysed
    0 [20]
    0 [21]
    Units: days
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [20] - Data not assessed since study was terminated early due to delay in providing additional drug.
    [21] - Data not assessed since study was terminated early due to delay in providing additional drug.
    No statistical analyses for this end point

    Secondary: Total Dose of Recombinant Follicle Stimulating Hormone (r-FSH) Administered per Cycle

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    End point title
    		 Total Dose of Recombinant Follicle Stimulating Hormone (r-FSH) Administered per Cycle
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline up to 4 weeks
    End point values
    		 Low Dose Gonal-f Standard Low Dose Gonal-f
    Number of subjects analysed
    0 [22]
    0 [23]
    Units: IU
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [22] - Data not assessed since study was terminated early due to delay in providing additional drug.
    [23] - Data not assessed since study was terminated early due to delay in providing additional drug.
    No statistical analyses for this end point

    Secondary: Change From Baseline in Anti-Mullerian Hormone (AMH) levels at Week 4

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    End point title
    		 Change From Baseline in Anti-Mullerian Hormone (AMH) levels at Week 4
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline, Week 4
    End point values
    		 Low Dose Gonal-f Standard Low Dose Gonal-f
    Number of subjects analysed
    0 [24]
    0 [25]
    Units: nanogram/milliliter (ng/mL)
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [24] - Data not assessed since study was terminated early due to delay in providing additional drug.
    [25] - Data not assessed since study was terminated early due to delay in providing additional drug.
    No statistical analyses for this end point

    Secondary: Testosterone Levels

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    End point title
    		 Testosterone Levels
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline
    End point values
    		 Low Dose Gonal-f Standard Low Dose Gonal-f
    Number of subjects analysed
    0 [26]
    0 [27]
    Units: ng/mL
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [26] - Data not assessed since study was terminated early due to delay in providing additional drug.
    [27] - Data not assessed since study was terminated early due to delay in providing additional drug.
    No statistical analyses for this end point

    Secondary: Sex Hormone Binding Globulin (SHBG) levels

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    End point title
    		 Sex Hormone Binding Globulin (SHBG) levels
    End point description
    End point type
    Secondary
    End point timeframe
    Baseline
    End point values
    		 Low Dose Gonal-f Standard Low Dose Gonal-f
    Number of subjects analysed
    0 [28]
    0 [29]
    Units: ng/mL
        arithmetic mean (standard deviation)
    ( )
    ( )
    Notes
    [28] - Data not assessed since study was terminated early due to delay in providing additional drug.
    [29] - Data not assessed since study was terminated early due to delay in providing additional drug.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From baseline up to 8 months.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    17.1
    Reporting groups
    Reporting group title
    Standard Low Dose Gonal-f
    Reporting group description
    		 Gonal-f was administered subcutaneously daily at a starting dose of 50 International Units (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, up to maximum dose of 125 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.

    Reporting group title
    Low Dose Gonal-f
    Reporting group description
    		 Gonal-f was administered subcutaneously daily at a starting dose of 50 International unit (IU) for Week 1, then dose was gradually increased by 12.5 IU for two weeks, with a final increase of 25 IU, up to maximum dose of 100 IU, until Week 4 for subjects with minimal response. After adequate follicular development was achieved, the subject was administration human chorionic gonadotropin (hCG) within 24-48 hours of last Gonal-f injection as per investigator discretion.

    Serious adverse events
    		 Standard Low Dose Gonal-f Low Dose Gonal-f
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Pregnancy, puerperium and perinatal conditions
    Abortion spontaneous
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Standard Low Dose Gonal-f Low Dose Gonal-f
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    3 / 12 (25.00%)
    2 / 12 (16.67%)
    Nervous system disorders
    Headache
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    General disorders and administration site conditions
    Pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Gastrointestinal disorders
    Abdominal pain
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Dry Mouth
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Abdominal tenderness
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Nausea
    alternative assessment type: Non-systematic
         subjects affected / exposed
    0 / 12 (0.00%)
    1 / 12 (8.33%)
         occurrences all number
    0
    1
    Reproductive system and breast disorders
    Breast tenderness
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0
    Vaginal discharge
    alternative assessment type: Non-systematic
         subjects affected / exposed
    1 / 12 (8.33%)
    0 / 12 (0.00%)
         occurrences all number
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    24 Oct 2013
    • The number of subjects planned to be enrolled in the study was updated to 116, a total of 55 subjects were planned to be enrolled in each arm. • Inclusion Criterion was added to ensure only subjects with clinically significant abnormal serum levels of Prolactin (PRL) in the early follicular phase were excluded. This change was made to ensure subjects with abnormal but not clinically significant serum levels of PRL were able to participate in the study. • Inclusion Criteria 8 and 9 were updated to include laparoscopy as an acceptable method to assess normal uterine cavity and tube patency in addition to hysteroscopy, Hysterosalpingography (HSG), or ultrasound scan. This change was made to ensure that all methods by which tube patency may be assessed were included. • Amended the PP protocol population definition in order to clarify the analysis population.

    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.
    Study was terminated because of delays in sourcing replacement Investigational Medicinal Product (IMP) for the study due to manufacturing delays hence the outcome measure was not assessed.
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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
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