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    Clinical Trial Results:
    Comparative study between the usage of corifollitropin alfa and daily recombinant FSH in the ovarian stimulation of low responders

    Summary
    EudraCT number
    		 2013-002979-17
    Trial protocol
    		 ES  
    Global end of trial date
    16 Nov 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    30 Oct 2020
    First version publication date
    30 Oct 2020
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    1309-SEV-130-MF
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    IVI Sevilla
    Sponsor organisation address
    Avenida República Argentina 58 Sevilla, Sevilla, Spain,
    Public contact
    Research associate, IVI Sevilla, +34 954286274, victor.blasco@ivi.es
    Scientific contact
    Research associate, IVI Sevilla, +34 954286274, victor.blasco@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
    16 Nov 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    16 Nov 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    To evaluate the effect on the number of mature oocytes obtained after the follicular puncture depending on the stimulation protocol applied: -Stimulation protocol A (experimental): controlled ovarian stimulation using corifollitropin alfa -Stimulation protocol B (control): controlled ovarian stimulation using recombinant FSH and highly purified HMG
    Protection of trial subjects
    None
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 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
    Spain: 26
    Worldwide total number of subjects
    26
    EEA total number of subjects
    26
    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)
    26
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients will be recruited for a year (from November 2013 to November 2014).

    Pre-assignment
    Screening details
    		 They must go through at least two stimulation cycles. -They are low responders to ovarian stimulation according to the Bologna criteria. -They accept voluntarily to participate in the trial signing an informed consent form. According to the Bologna criteria, at least two of the following three features must be present to be considered low r

    Pre-assignment period milestones
    Number of subjects started
    		 26
    Number of subjects completed
    		 11

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 Physician decision: 15
    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Elonva
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Elonva
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    150 μg microgram

    Number of subjects in period 1 [1]
    		Elonva
    Started
    11
    Completed
    11
    Notes
    [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: Premature cancellation

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Elonva
    Reporting group description
    		 -

    Primary: Number of mature oocytes obtained after the follicular puncture

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    End point title
    		 Number of mature oocytes obtained after the follicular puncture [1]
    End point description
    End point type
    Primary
    End point timeframe
    1 year
    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: Premature cancellation. Results have not been analysed
    End point values
    		 Elonva
    Number of subjects analysed
    0 [2]
    Units: %
    Notes
    [2] - Premature cancellation
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    3 months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    1
    Frequency threshold for reporting non-serious adverse events: 1%
    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: Phase IV study with a low level of intervention. No adverse events were detected

    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? Yes
    Date
    Interruption
    Restart date
    16 Nov 2015
    No funding
    -

    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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