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    Clinical Trial Results:
    Corifollitropin alfa followed by hp-HMG versus recombinant FSH in young poor ovarian responders. A multicentre randomized controlled clinical trial

    Summary
    EudraCT number
    		 2013-000583-29
    Trial protocol
    		 BE  
    Global end of trial date
    31 May 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    02 Jul 2022
    First version publication date
    02 Jul 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    143201316398
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01816321
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Universitair Ziekenhuis Brussel
    Sponsor organisation address
    Laarbeeklaan 101, Brussel, Belgium, 1090
    Public contact
    Nikolaos Polyzos, Universitair Ziekenhuis Brussel, 0032 24776699, nikolaos.polyzos@uzbrussel.be
    Scientific contact
    Nikolaos Polyzos, Universitair Ziekenhuis Brussel, 0032 24776699, nikolaos.polyzos@uzbrussel.be
    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
    30 Dec 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    31 May 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    31 May 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To compare pregnancy rates after treament with corifollitropin alfa followed by highly purified HMG versus recombinant FSH in a GnRH antagonist protocol, for the treatment of young poor ovarian responders undergoing ovarian stimulation for ICSI
    Protection of trial subjects
    Treated in Routine care
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Mar 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
    Belgium: 88
    Country: Number of subjects enrolled
    Viet Nam: 64
    Worldwide total number of subjects
    152
    EEA total number of subjects
    88
    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)
    152
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Enrolment was performed from March 2013 to May 2016.

    Pre-assignment
    Screening details
    		 Eligible Patient are screened in period March 2013- May 2016 ,

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    No blinding

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 COrifollitropin alfafollowed by Menotropin for Poor Ovarian R
    Arm description
    		 Patients will be randomised to either corifollitropin alfa followed by hpHMG (Group A) or to rFSH (Group B)
    Arm type
    		 Experimental

    Investigational medicinal product name
    corifollitropin alfa
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    150 µg corifollitropin alfa ,subcutaneous

    Arm title
    		 rFSH
    Arm description
    		 Reference group: a daily SC dose of rFSH ( 300 IU/day)
    Arm type
    		 Active comparator

    Investigational medicinal product name
    rFSH
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    300IU daily

    Number of subjects in period 1
    		COrifollitropin alfafollowed by Menotropin for Poor Ovarian R rFSH
    Started
    77
    75
    Completed
    77
    75

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    overall trial
    Reporting group description
    		 -

    Reporting group values
    		 overall trial Total
    Number of subjects
    		 152 152
    Age categorical
    age defined by inclusion criteria : less than 40 years
    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)
    		 152 152
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
        18-40 years
    		 0 0
    Age continuous
    Units: years
        log mean (standard deviation)
    		 0 ± 0 -
    Gender categorical
    Units: Subjects
        Female
    		 152 152
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    COrifollitropin alfafollowed by Menotropin for Poor Ovarian R
    Reporting group description
    		 Patients will be randomised to either corifollitropin alfa followed by hpHMG (Group A) or to rFSH (Group B)

    Reporting group title
    rFSH
    Reporting group description
    		 Reference group: a daily SC dose of rFSH ( 300 IU/day)

    Primary: ongoing pregnancy rates

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    End point title
    		 ongoing pregnancy rates
    End point description
    The primary efficacy endpoint is the ongoing pregnancy rates, defined as the presence of intrauterine gestational sac with an embryonic pole demonstrating cardiac activity at 9-10 weeks of gestation. The primary efficacy endpoint is related to the primary trial objective.
    End point type
    Primary
    End point timeframe
    cardiac activity at 9-10 weeks of gestation
    End point values
    		 COrifollitropin alfafollowed by Menotropin for Poor Ovarian R rFSH
    Number of subjects analysed
    77
    75
    Units: 22
        number (not applicable)
    77
    75
    Statistical analysis title
    		 Statistical Analysis
    Comparison groups
    COrifollitropin alfafollowed by Menotropin for Poor Ovarian R v rFSH
    Number of subjects included in analysis
    152
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 ≤ 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Mean difference (final values)
    Confidence interval
         level
    		 85%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard deviation

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    March 2013- May 2016
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16.0
    Frequency threshold for reporting non-serious adverse events: 0%
    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 Adverse events reported

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    30 Nov 2015
    Amendment 1, protocol vs 2 , 2 Nov 2015 : Department of Obstetrics and Gynaecology, University of Medicine and Pharmacy HCMC, Ho Chi Minh City, Vietnam is added as 2nd recruiting site in this 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.
    no
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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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