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    Clinical Trial Results:
    A single centre open-label randomised controlled trial of long term pituitary down-regulation before in vitro fertilisation for women with endometriosis: a pilot study

    Summary
    EudraCT number
    		 2012-004954-27
    Trial protocol
    		 GB  
    Global end of trial date
    07 Nov 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Feb 2019
    First version publication date
    21 Feb 2019
    Other versions
    Summary report(s)
    		 Final report eraly termination

    Trial information

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    Trial identification
    Sponsor protocol code
    8668
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University of Oxford
    Sponsor organisation address
    Boundary Brook House, Churchill Drive, Oxford, United Kingdom, OX3 7GB
    Public contact
    Research Services, Clinical Trials and Research Governance, 44 1865616484,
    Scientific contact
    Research Services, Clinical Trials and Research Governance, 44 1865616484,
    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
    07 Nov 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    07 Nov 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    07 Nov 2013
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to determine if pre-treatment with oral contraceptives improves IVF or IVF-ICSI success rates (i.e. live birth rates) in patients who suffer from endometriosis.
    Protection of trial subjects
    None
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jan 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: 5
    Worldwide total number of subjects
    5
    EEA total number of subjects
    5
    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)
    5
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The study participants were women undertaking IVF or IVF-ICSI cycles at the Oxford Fertility Unit between January 2013 (to January 2015).

    Pre-assignment
    Screening details
    		 Infertile women with endometriosis undergoing IVF or IVF-ICSI

    Period 1
    Period 1 title
    Baseline (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Control
    Arm description
    		 No intervention
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 COCP
    Arm description
    		 8 weeks of COCP before IVF cycle
    Arm type
    		 Experimental

    Investigational medicinal product name
    Microgynon 30 (COCP)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Microgynon, Levonorgestrel/Ethinylestradiol 150/30mcg daily for 8 weeks

    Number of subjects in period 1
    		Control COCP
    Started
    2
    3
    Completed
    2
    3

    Baseline characteristics

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

    Reporting group values
    		 Baseline Total
    Number of subjects
    		 5 5
    Age categorical
    Women aged between 18 and 39 years of age
    Units: Subjects
        all participants
    		 5 5
    Gender categorical
    Units: Subjects
        Female
    		 5 5

    End points

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    End points reporting groups
    Reporting group title
    Control
    Reporting group description
    		 No intervention

    Reporting group title
    COCP
    Reporting group description
    		 8 weeks of COCP before IVF cycle

    Primary: Live Birth Rate

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    End point title
    		 Live Birth Rate [1]
    End point description
    End point type
    Primary
    End point timeframe
    40 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: 5 participants. Early termination of the study. No statistical analyses were performed.
    End point values
    		 Control COCP
    Number of subjects analysed
    2 [2]
    3 [3]
    Units: Live Births (number)
    0
    0
    Notes
    [2] - No analysis done for this trial
    [3] - No analysis done for this trial
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    between January 2013 to November 2013.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    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: 5 participants. Early termination of the study. No adverse events.

    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.
    In November 2013 the decision was made for early termination of the study. Despite our best efforts, only 5 women had been recruited and this rate of recruitment is unlikely to increase significantly in the future. Clearly no evaluation can be made f
    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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