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    Clinical Trial Results:
    The use of GnRH antagonist versus co-flare protocol for women with low ovarian reserve undergoing first cycle of in vitro fertilization

    Summary
    EudraCT number
    		 2012-004824-39
    Trial protocol
    		 GB  
    Global end of trial date
    31 Dec 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Feb 2020
    First version publication date
    20 Feb 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    EDGE ID 34459
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University Hospitals of Leicester NHS Trust
    Sponsor organisation address
    Infirmary Road, Leicester, United Kingdom, LE1 5WW
    Public contact
    Mr Gelbaya, University Hospitals of Leicester NHS Trust, tarek.gelbaya@uhl-tr.nhs.uk
    Scientific contact
    Mr Gelbaya, University Hospitals of Leicester NHS Trust, tarek.gelbaya@uhl-tr.nhs.uk
    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
    31 Dec 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 Dec 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    31 Dec 2016
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To compare the effect of two different treatment protocols of ovarian stimulation for IVF on the number of eggs retrieved from women with low ovarian reserve undergoing their first IVF cycle: the co-flare protocol and the GnRH-antagonist protocol.
    Protection of trial subjects
    Ethics favourable opinion will be obtained from an appropriate committee. The Trust R &D approval is mandatory.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Sep 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
    United Kingdom: 4
    Worldwide total number of subjects
    4
    EEA total number of subjects
    4
    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)
    4
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Participants We aim to recruit 60 women with low serum AMH (3.08-21.97 pmol/l) who are about to start their first IVF treatment cycle. Randomisation procedure Central randomisation will be employed and coordinated by the trial statistician (from Quanticate, an independent clinical research organisation) who will not be involved in patients’ rec

    Pre-assignment
    Screening details
    		 • Women 23-39 years, with body mass index (BMI) of 19-30 Kg/m2, who are ready to start their first IVF treatment cycle with or without ICSI, with serum FSH between 10 and 14.99, who were subsequently found to have low AMH (3.08-21.97 pmol/L). (These AMH levels are compatible with low ovarian reserve on Gen II assay results

    Period 1
    Period 1 title
    Recruitment overall period
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    participants are allocated to 1 of 2 treatment arms using the central allocation system.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm 1
    Arm description
    		 The short agonist protocol
    Arm type
    		 Experimental

    Investigational medicinal product name
    buserelin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Daily dose of 500mcg administered subcutaneous

    Arm title
    		 Arm 2
    Arm description
    		 The antagonist protocol
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Cetrotide
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    daily dose of 0.25mg administered by subcutaneous injection

    Number of subjects in period 1
    		Arm 1 Arm 2
    Started
    2
    2
    Completed
    1
    0
    Not completed
    1
    2
         withdrawn prior to dosing
    1
    1
         withdrawn prior to randomisation
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Recruitment overall period
    Reporting group description
    		 -

    Reporting group values
    		 Recruitment overall period Total
    Number of subjects
    		 4 4
    Age categorical
    Units: Subjects
        In utero
    		 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0
        Newborns (0-27 days)
    		 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0
        Children (2-11 years)
    		 0 0
        Adolescents (12-17 years)
    		 0 0
        Adults (18-64 years)
    		 4 4
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
    Gender categorical
    females between the ages of 23-39
    Units: Subjects
        Female
    		 4 4
        Not recorded
    		 0 0
    Subject analysis sets

    Subject analysis set title
    recruitment
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    number of subjects recruited

    Subject analysis sets values
    		 recruitment
    Number of subjects
    1
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    4
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units:
        
    ±
    Gender categorical
    females between the ages of 23-39
    Units: Subjects
        Female
    4
        Not recorded
    0

    End points

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    End points reporting groups
    Reporting group title
    Arm 1
    Reporting group description
    		 The short agonist protocol

    Reporting group title
    Arm 2
    Reporting group description
    		 The antagonist protocol

    Subject analysis set title
    recruitment
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    number of subjects recruited

    Primary: Live birth

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    End point title
    		 Live birth [1]
    End point description
    End point type
    Primary
    End point timeframe
    40 weeks of pregnancy/ 10 months where dosed
    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: Minimal recruitment to the study. 4 subjects in total. Of these three subjects withdrew prior to dosing. No analysis undertaken.
    End point values
    		 Arm 1 Arm 2
    Number of subjects analysed
    0 [2]
    0 [3]
    Units: 40 weeks of pregnancy
        number (not applicable)
    Notes
    [2] - Minimal recruitment with only one subject randomised. No analysis undertaken
    [3] - 3 subjects withdrew prior to dosing
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    10 months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    22.1
    Reporting groups
    Reporting group title
    the antagonist protocol
    Reporting group description
    		 -

    Reporting group title
    The short agonist protocol
    Reporting group description
    		 -

    Serious adverse events
    		 the antagonist protocol The short agonist protocol
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 2 (0.00%)
    0 / 2 (0.00%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 the antagonist protocol The short agonist protocol
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 2 (0.00%)
    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: No non-serious adverse events were reported for this trial.

    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
    For support, Contact us.
    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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