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    Clinical Trial Results:
    A Randomised, Parallel Group, Assessor-Blind, Multicentre Study to Compare the Safety and Efficacy of Actavis rhFSH with Follitropin Alfa (GONAL-f®) in Stimulating Multiple Follicular Development in Women Participating in an Assisted Reproductive Technology Program

    Summary
    EudraCT number
    		 2013-003788-67
    Trial protocol
    		 BE   GB   ES   AT  
    Global end of trial date
    08 Nov 2014

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Sep 2018
    First version publication date
    01 Sep 2018
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    FS1306
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Allergan plc
    Sponsor organisation address
    Clonshaugh Business & Technology Park, Coolock, Dublin, Ireland, D17 E400
    Public contact
    Clinical Trial Registry Team, Allergan plc, 001 877-277-8566, IR-CTRegistration@Allergan.com
    Scientific contact
    Therapeutic Area Head, Allergan plc, 001 862-261-7000, IR-CTRegistration@Allergan.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
    08 Nov 2014
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    08 Nov 2014
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To demonstrate equivalence between the numbers of oocytes retrieved after treatment with Actavis recombinant human follicle-stimulating hormone (rhFSH) or GONAL-f (follitropin alfa) in ovulatory participants in an assisted reproductive technology (ART) program.
    Protection of trial subjects
    All study participants were required to read and sign an Informed Consent Form.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Sep 2014
    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
    Belgium: 2
    Worldwide total number of subjects
    2
    EEA total number of subjects
    2
    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)
    2
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants were enrolled at one study site in Belgium.

    Pre-assignment
    Screening details
    		 Female participants, who were diagnosed with infertility, 18 to 35 years of age (inclusive) and were eligible for the Assisted Reproductive Technology (ART) program, were randomised in the study to one of two treatment arms: Actavis rhFSH or comparator GONAL-f. The study was terminated and no participants were enrolled in the GONAL-f arm.

    Period 1
    Period 1 title
    Overall Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind [1]
    Roles blinded
    		 Investigator, Data analyst

    Arms
    Arm title
    		 Actavis rhFSH
    Arm description
    		 During ART Cycle 1: once daily treatments with 150 International Units (IU) of Actavis rhFSH, subcutaneously for 5 days. Dose adjustment after 5 days up to maximum of 225 IU for a maximum of 19 days. If second ART cycle was needed: Actavis rhFSH dosing 150-225 IU once daily for 5 days and up to 300 IU up to 19 days. Starting on Day 5 of the Actavis rhFSH treatment until the day of human chorionic gonadotropin (hCG) injection daily injections of ganirelix acetate at a dose of 0.25 mg/0.5 mL. Single dose of 250 mcg recombinant hCG by injection once 3 or more follicles/cysts were ≥ 17 mm.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ganirelix acetate
    Investigational medicinal product code
    Other name
    Orgalutran®
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Starting on Day 5 of the FSH treatment and continuing daily until the day of human chorionic gonadotropin (hCG) injection daily injections of ganirelix acetate at a dose of 0.25 mg/0.5 mL.

    Investigational medicinal product name
    Actavis rhFSH
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    During ART Cycle 1: once daily treatments with 150 IU dose subcutaneously for 5 days. Dose adjustment after 5 days up to maximum of 225 IU for a maximum of 19 days. If a second ART cycle was needed: 150-225 IU once daily for 5 days and up to 300 IU up to 19 days.

    Investigational medicinal product name
    Human chorionic gonadotropin (hCG)
    Investigational medicinal product code
    Other name
    Ovitrelle®
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Single dose of 250 mcg recombinant hCG by injection.

    Notes
    [1] - The roles blinded appear to be inconsistent with a double blind trial.
    Justification: Investigator and data analyst were the blinded roles for this study.
    Number of subjects in period 1
    		Actavis rhFSH
    Started
    2
    Completed
    0
    Not completed
    2
         Early Termination of Study by Sponsor
    1
         Insufficient Therapeutic Response
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Actavis rhFSH
    Reporting group description
    		 During ART Cycle 1: once daily treatments with 150 International Units (IU) of Actavis rhFSH, subcutaneously for 5 days. Dose adjustment after 5 days up to maximum of 225 IU for a maximum of 19 days. If second ART cycle was needed: Actavis rhFSH dosing 150-225 IU once daily for 5 days and up to 300 IU up to 19 days. Starting on Day 5 of the Actavis rhFSH treatment until the day of human chorionic gonadotropin (hCG) injection daily injections of ganirelix acetate at a dose of 0.25 mg/0.5 mL. Single dose of 250 mcg recombinant hCG by injection once 3 or more follicles/cysts were ≥ 17 mm.

    Reporting group values
    		 Actavis rhFSH Total
    Number of subjects
    		 2 2
    Age Categorical
    Units: Subjects
        <=18 years
    		 0 0
        Between 18 and 65 years
    		 2 2
        >=65 years
    		 0 0
    Sex: Female, Male
    Units: Subjects
        Female
    		 2 2
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    Actavis rhFSH
    Reporting group description
    		 During ART Cycle 1: once daily treatments with 150 International Units (IU) of Actavis rhFSH, subcutaneously for 5 days. Dose adjustment after 5 days up to maximum of 225 IU for a maximum of 19 days. If second ART cycle was needed: Actavis rhFSH dosing 150-225 IU once daily for 5 days and up to 300 IU up to 19 days. Starting on Day 5 of the Actavis rhFSH treatment until the day of human chorionic gonadotropin (hCG) injection daily injections of ganirelix acetate at a dose of 0.25 mg/0.5 mL. Single dose of 250 mcg recombinant hCG by injection once 3 or more follicles/cysts were ≥ 17 mm.

    Primary: Number of Oocytes Retrieved in the First Assisted Reproductive Technology (ART) Cycle

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    End point title
    		 Number of Oocytes Retrieved in the First Assisted Reproductive Technology (ART) Cycle [1]
    End point description
    The Modified Intent-to-Treat (MITT) population, all randomised participants who received at least 1 dose of GONAL-f or Actavis rhFSH, with data available for analysis.
    End point type
    Primary
    End point timeframe
    Up to end of first ART cycle (up to approximately 15 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: No statistical analyses are reported for this Endpoint.
    End point values
    		 Actavis rhFSH
    Number of subjects analysed
    0 [2]
    Units: oocytes
        arithmetic mean (standard deviation)
    ( )
    Notes
    [2] - Data not collected as participants discontinued study prior to oocyte retrieval.
    No statistical analyses for this end point

    Secondary: Pregnancy Rate

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    End point title
    		 Pregnancy Rate
    End point description
    Pregnancy rate was defined as percentage of participants with presence of at least one fetus with heart activity, at 10 weeks after embryo transfer. The per-protocol (PP) population, all participants in the MITT Population who, in the first ART cycle, completed the test or reference article treatment, had hCG injection, had oocyte retrieval, did not miss any ganirelix injections, did not have cycle cancellation, were without major protocol violation(s) and had data available for analysis.
    End point type
    Secondary
    End point timeframe
    Up to end of first ART cycle (up to approximately 15 weeks)]
    End point values
    		 Actavis rhFSH
    Number of subjects analysed
    0 [3]
    Units: percentage of participants
        number (not applicable)
    Notes
    [3] - No participants in the PP population as participants discontinued study prior to cycle completion.
    No statistical analyses for this end point

    Secondary: Total Drug Dose Required During the ART Cycle

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    End point title
    		 Total Drug Dose Required During the ART Cycle
    End point description
    The PP population, all participants in the MITT Population who, in the first ART cycle, completed the test or reference article treatment, had hCG injection, had oocyte retrieval, did not miss any ganirelix injections, did not have cycle cancellation, were without major protocol violation(s) and had data available for analysis.
    End point type
    Secondary
    End point timeframe
    Up to end of first ART cycle (up to approximately 15 weeks)
    End point values
    		 Actavis rhFSH
    Number of subjects analysed
    0 [4]
    Units: International Units (IU)
        arithmetic mean (standard deviation)
    ( )
    Notes
    [4] - No participants in the PP population as participants discontinued study prior to cycle completion.
    No statistical analyses for this end point

    Secondary: Number of Days of Drug Stimulation During the ART Cycle

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    End point title
    		 Number of Days of Drug Stimulation During the ART Cycle
    End point description
    The PP population, all participants in the MITT Population who, in the first ART cycle, completed the test or reference article treatment, had hCG injection, had oocyte retrieval, did not miss any ganirelix injections, did not have cycle cancellation, were without major protocol violation(s) and had data available for analysis.
    End point type
    Secondary
    End point timeframe
    Up to end of first ART cycle (up to approximately 15 weeks)
    End point values
    		 Actavis rhFSH
    Number of subjects analysed
    0 [5]
    Units: days
        arithmetic mean (standard deviation)
    ( )
    Notes
    [5] - No participants in the PP population as participants discontinued study prior to cycle completion.
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Require an Increase of the Drug Dose

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    End point title
    		 Percentage of Participants Who Require an Increase of the Drug Dose
    End point description
    The PP population, all participants in the MITT Population who, in the first ART cycle, completed the test or reference article treatment, had hCG injection, had oocyte retrieval, did not miss any ganirelix injections, did not have cycle cancellation, were without major protocol violation(s) and had data available for analysis.
    End point type
    Secondary
    End point timeframe
    Up to end of first ART cycle (up to approximately 15 weeks)
    End point values
    		 Actavis rhFSH
    Number of subjects analysed
    0 [6]
    Units: percentage of participants
        number (not applicable)
    Notes
    [6] - No participants in the PP population as participants discontinued study prior to cycle completion.
    No statistical analyses for this end point

    Secondary: Percentage of Participants Who Require a Decrease of the Drug Dose

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    End point title
    		 Percentage of Participants Who Require a Decrease of the Drug Dose
    End point description
    The PP population, all participants in the MITT Population who, in the first ART cycle, completed the test or reference article treatment, had hCG injection, had oocyte retrieval, did not miss any ganirelix injections, did not have cycle cancellation, were without major protocol violation(s) and had data available for analysis.
    End point type
    Secondary
    End point timeframe
    Up to end of first ART cycle (up to approximately 15 weeks)
    End point values
    		 Actavis rhFSH
    Number of subjects analysed
    0 [7]
    Units: percentage of participants
        number (not applicable)
    Notes
    [7] - No participants in the PP population as participants discontinued study prior to cycle completion.
    No statistical analyses for this end point

    Secondary: Number of Follicles/Cysts with Sizes ≥ 11 mm, ≥ 15 mm, or ≥ 17 mm

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    End point title
    		 Number of Follicles/Cysts with Sizes ≥ 11 mm, ≥ 15 mm, or ≥ 17 mm
    End point description
    The PP population, all participants in the MITT Population who, in the first ART cycle, completed the test or reference article treatment, had hCG injection, had oocyte retrieval, did not miss any ganirelix injections, did not have cycle cancellation, were without major protocol violation(s) and had data available for analysis.
    End point type
    Secondary
    End point timeframe
    Day 6, Day of human chorionic gonadotropin (hCG) administration (approximately Day 6-19)
    End point values
    		 Actavis rhFSH
    Number of subjects analysed
    0 [8]
    Units: follicles/cysts
        arithmetic mean (standard deviation)
    ( )
    Notes
    [8] - No participants in the PP population as participants discontinued study prior to cycle completion.
    No statistical analyses for this end point

    Secondary: Serum Concentration of Inhibin-B

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    End point title
    		 Serum Concentration of Inhibin-B
    End point description
    The PP population, all participants in the MITT Population who, in the first ART cycle, completed the test or reference article treatment, had hCG injection, had oocyte retrieval, did not miss any ganirelix injections, did not have cycle cancellation, were without major protocol violation(s) and had data available for analysis.
    End point type
    Secondary
    End point timeframe
    Pre-treatment on Day 1 and on day of hCG administration (approximately Day 6-19)
    End point values
    		 Actavis rhFSH
    Number of subjects analysed
    0 [9]
    Units: picograms per milliliter (pg/mL)
        arithmetic mean (standard deviation)
    ( )
    Notes
    [9] - No participants in the PP population as participants discontinued study prior to cycle completion.
    No statistical analyses for this end point

    Secondary: Serum Concentration of Estradiol (E2)

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    End point title
    		 Serum Concentration of Estradiol (E2)
    End point description
    The PP population, all participants in the MITT Population who, in the first ART cycle, completed the test or reference article treatment, had hCG injection, had oocyte retrieval, did not miss any ganirelix injections, did not have cycle cancellation, were without major protocol violation(s) and had data available for analysis.
    End point type
    Secondary
    End point timeframe
    Pre-treatment on Day 1 and on day of hCG administration (approximately Day 6-19)
    End point values
    		 Actavis rhFSH
    Number of subjects analysed
    0 [10]
    Units: pg/mL
        arithmetic mean (standard deviation)
    ( )
    Notes
    [10] - No participants in the PP population as participants discontinued study prior to cycle completion.
    No statistical analyses for this end point

    Secondary: Serum Concentration of Luteinizing Hormone (LH)

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    End point title
    		 Serum Concentration of Luteinizing Hormone (LH)
    End point description
    The PP population, all participants in the MITT Population who, in the first ART cycle, completed the test or reference article treatment, had hCG injection, had oocyte retrieval, did not miss any ganirelix injections, did not have cycle cancellation, were without major protocol violation(s) and had data available for analysis.
    End point type
    Secondary
    End point timeframe
    Pre-treatment on Day 1 and on day of hCG administration (approximately Day 6-19)
    End point values
    		 Actavis rhFSH
    Number of subjects analysed
    0 [11]
    Units: International Units per Liter (IU/L)
        arithmetic mean (standard deviation)
    ( )
    Notes
    [11] - No participants in the PP population as participants discontinued study prior to cycle completion.
    No statistical analyses for this end point

    Secondary: Serum Concentration of FSH

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    End point title
    		 Serum Concentration of FSH
    End point description
    The PP population, all participants in the MITT Population who, in the first ART cycle, completed the test or reference article treatment, had hCG injection, had oocyte retrieval, did not miss any ganirelix injections, did not have cycle cancellation, were without major protocol violation(s) and had data available for analysis.
    End point type
    Secondary
    End point timeframe
    Pre-treatment on Day 1 and on day of hCG administration (approximately Day 6-19)
    End point values
    		 Actavis rhFSH
    Number of subjects analysed
    0 [12]
    Units: IU/L
        arithmetic mean (standard deviation)
    ( )
    Notes
    [12] - No participants in the PP population as participants discontinued study prior to cycle completion.
    No statistical analyses for this end point

    Secondary: Serum Concentration of Progesterone

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    End point title
    		 Serum Concentration of Progesterone
    End point description
    The PP population, all participants in the MITT Population who, in the first ART cycle, completed the test or reference article treatment, had hCG injection, had oocyte retrieval, did not miss any ganirelix injections, did not have cycle cancellation, were without major protocol violation(s) and had data available for analysis.
    End point type
    Secondary
    End point timeframe
    Pre-treatment on Day 1 and on day of hCG administration (approximately Day 6-19)
    End point values
    		 Actavis rhFSH
    Number of subjects analysed
    0 [13]
    Units: nanograms per milliliter (ng/mL)
        arithmetic mean (standard deviation)
    ( )
    Notes
    [13] - No participants in the PP population as participants discontinued study prior to cycle completion.
    No statistical analyses for this end point

    Secondary: Number of Fertilised Oocytes at 24 Hours after the Initiation of the in vitro Fertilisation (IVF) for Participants Who Are Not Choosing ICSI Procedure

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    End point title
    		 Number of Fertilised Oocytes at 24 Hours after the Initiation of the in vitro Fertilisation (IVF) for Participants Who Are Not Choosing ICSI Procedure
    End point description
    The PP population, all participants in the MITT Population who, in the first ART cycle, completed the test or reference article treatment, had hCG injection, had oocyte retrieval, did not miss any ganirelix injections, did not have cycle cancellation, were without major protocol violation(s) and had data available for analysis.
    End point type
    Secondary
    End point timeframe
    Up to end of first ART cycle (up to approximately 15 weeks)]
    End point values
    		 Actavis rhFSH
    Number of subjects analysed
    0 [14]
    Units: fertilised oocytes
        arithmetic mean (standard deviation)
    ( )
    Notes
    [14] - No participants in the PP population as participants discontinued study prior to cycle completion.
    No statistical analyses for this end point

    Secondary: Number of Metaphase II Oocytes after Oocyte Retrieval for Participants with ICSI Procedure

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    End point title
    		 Number of Metaphase II Oocytes after Oocyte Retrieval for Participants with ICSI Procedure
    End point description
    Metaphase II oocytes are defined as having extruded the first polar body and are in the resting phase of meiosis II. The PP population, all participants in the MITT Population who, in the first ART cycle, completed the test or reference article treatment, had hCG injection, had oocyte retrieval, did not miss any ganirelix injections, did not have cycle cancellation, were without major protocol violation(s) and had data available for analysis.
    End point type
    Secondary
    End point timeframe
    Up to end of first ART cycle (up to approximately 15 weeks)]
    End point values
    		 Actavis rhFSH
    Number of subjects analysed
    0 [15]
    Units: metaphase II oocytes
        arithmetic mean (standard deviation)
    ( )
    Notes
    [15] - No participants in the PP population as participants discontinued study prior to cycle completion.
    No statistical analyses for this end point

    Secondary: Number of Grade 1 and Grade 2 Embryos on Day 3 of Embryo Culture

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    End point title
    		 Number of Grade 1 and Grade 2 Embryos on Day 3 of Embryo Culture
    End point description
    The PP population, all participants in the MITT Population who, in the first ART cycle, completed the test or reference article treatment, had hCG injection, had oocyte retrieval, did not miss any ganirelix injections, did not have cycle cancellation, were without major protocol violation(s) and had data available for analysis.
    End point type
    Secondary
    End point timeframe
    Up to end of first ART cycle (up to approximately 15 weeks)
    End point values
    		 Actavis rhFSH
    Number of subjects analysed
    0 [16]
    Units: embryos
        arithmetic mean (standard deviation)
    ( )
    Notes
    [16] - No participants in the PP population as participants discontinued study prior to cycle completion.
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Adverse Event (AEs)

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    End point title
    		 Percentage of Participants with Adverse Event (AEs)
    End point description
    Any untoward medical occurrence in a participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavourable and unintended sign (including an abnormal laboratory finding, for example), symptom or disease temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. In addition to novel events, an adverse event may be an exacerbation of a pre-existing medical condition that was present before the first test or reference article administration. Safety population included all participants who received at least one dose of study medication, with data available for analysis.
    End point type
    Secondary
    End point timeframe
    From baseline to end of study (up to Day 10)
    End point values
    		 Actavis rhFSH
    Number of subjects analysed
    2
    Units: percentage of participants
        number (not applicable)
    0
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Ovarian Hyperstimulation Syndrome (OHSS)

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    End point title
    		 Percentage of Participants with Ovarian Hyperstimulation Syndrome (OHSS)
    End point description
    The safety population included all participants who received at least one dose of study medication, with data available for analysis.
    End point type
    Secondary
    End point timeframe
    From baseline to end of study (up to Day 10)
    End point values
    		 Actavis rhFSH
    Number of subjects analysed
    2
    Units: percentage of participants
        number (not applicable)
    0
    No statistical analyses for this end point

    Secondary: Percentage of Participants with ART Cycle Cancellation Due to Safety Reasons

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    End point title
    		 Percentage of Participants with ART Cycle Cancellation Due to Safety Reasons
    End point description
    The safety population included all participants who received at least one dose of study medication, with data available for analysis.
    End point type
    Secondary
    End point timeframe
    From baseline to end of study (up to Day 10)
    End point values
    		 Actavis rhFSH
    Number of subjects analysed
    2
    Units: percentage of participants
        number (not applicable)
    0
    No statistical analyses for this end point

    Secondary: Percentage of Participants with Anti-FSH Antibodies

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    End point title
    		 Percentage of Participants with Anti-FSH Antibodies
    End point description
    The safety population included all participants who received at least one dose of study medication, with data available for analysis.
    End point type
    Secondary
    End point timeframe
    From baseline to end of study (up to Day 10)
    End point values
    		 Actavis rhFSH
    Number of subjects analysed
    0 [17]
    Units: percentage of participants
        number (not applicable)
    Notes
    [17] - Data not collected as study was terminated early.
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    From baseline to end of study (up to Day 10)
    Adverse event reporting additional description
    Adverse Events are only reported for the Actavis rhFSH arm. No participants were enrolled in the GONAL-f arm.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    N/A
    Reporting groups
    Reporting group title
    Actavis rhFSH
    Reporting group description
    		 During ART Cycle 1: once daily treatments with 150 International Units (IU) of Actavis rhFSH subcutaneously for 5 days. Dose adjustment after 5 days up to maximum of 225 IU for a maximum of 19 days. If second ART cycle was needed: Actavis rhFSH dosing 150-225 IU once daily for 5 days and up to 300 IU up to 19 days. Starting on Day 5 of the Actavis rhFSH treatment until the day of human chorionic gonadotropin (hCG) injection daily injections of ganirelix acetate at a dose of 0.25 mg/0.5 mL. Single dose of 250 mcg recombinant hCG by injection once 3 or more follicles/cysts were ≥ 17 mm.

    Serious adverse events
    		 Actavis rhFSH
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 2 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Actavis rhFSH
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 2 (0.00%)
    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: There are no Non-serious Adverse Events that occurred at a threshold of >=5% participants in any arm.

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    12 Nov 2013
    Amendment 1: -Allowed higher initial and maximum FSH doses (225 and 300 IU respectively) for participants participating in the second ART cycle. -Adjusted the description of statistical analysis regarding primary efficacy endpoint and allowed the details of the statistical models to be discussed in SAP. -Added inquiries for infertility diagnosis, previous pregnancy/abortion history, and previous FSH exposure history in the Screening Visit 1. -Updated the Day 3 and Day 5 Embryo Assessment Criteria ased on the European Society of Human Reproductive and Embryology (ESHRE)’s most recent publication. -Combined and revised the Inclusion Criteria 4 and Exclusion Criteria 08 in the previous study protocol to redefine the ‘adequate ovarian reserve’ by both the serum FSH and AMH levels at Screening. -Redefined the Per-Protocol population as the second primary efficacy analysis population. -Added the summary of Phase 1 pharmacokinetic study (FS1203) results into the introduction section. -Removed the ferritin test from the clinical laboratory evaluations. -Changed the product name from Watson rhFSH to Actavis rhFSH throughout the document.
    14 Nov 2013
    Amendment 2: -Revised the Schedule of Events Tables (both first and second ART cycles) to list the study activities on the ‘Day of Oocyte Retrieval/in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) Procedure’ and ‘Day 1 of Embryo Culture’ in separate columns so that it will be congruent with the text of the study protocol and to clarify the start of ‘Day 1 of Embryo Culture’ -Revised the study procedures instructing sites to only record the size of each follicle/cyst ≥ 11 millimeters (mm) on FSH Treatment Day 1, Day 6, and the Day of hCG Injection.
    04 Mar 2014
    Amendment 3: -Removed the listing and description of doses and colors of five different strengths of auto-injectors. The healthcare providers will decide the dosing regimen for participants. -Revised the instruction for disposal of used auto-injectors. -Reduced the duration of allowable storage of auto-injectors at room temperature from up to 3 months to 7 days. -Adjusted the duration for the auto-injector to be placed at room temperature, if taken out of refrigerator (for warming up) before injection, from 10 minutes to 10-30 minutes. -Removed the information section for medical contact, devices manufacturer, and distributor. -Updated the corresponding protocol content to align with the revisions of the Instructions for Use for Actavis rhFSH Auto-Injectors. -Adjusted the starting time of adverse events assessment and documentation from the first test or reference article administration to the signing of informed consent. -Added the contact information for serious adverse event or medical emergency communication of the Medical Affairs of the Contract Research Organization. -Removed the specific timeslot of ‘within 30 minutes’ before test or reference article administration for blood sample collections. -Extended the ovarian hyperstimulation syndrome (OHSS) assessment, if needed, to at least 2 weeks after the hCG injection. -Added the description of study population of up to 60 subjects for second ART cycle. -Clarified the definition of ART cycle cancellation and related assessments for cycle cancellation. -Added description for the site personnel to remind participants to call the site if they experience any adverse events associated with the injection of rhFSH.
    15 Aug 2014
    Amendment 4: -Updated time windows and allow the sites more flexibility to accommodate participant's scheduling. -Clarification of study procedures. -Updated dosing of Crinone® Progesterone Gel 8%.

    Interruptions (globally)
    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    03 Nov 2014
    Due to business decisions, the study was terminated early by the Sponsor.
    -

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    Due to the early termination of the study, and with only 2 randomised participants in the study most analyses in this study could not be performed.
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