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    Clinical Trial Results:
    The effect of metformin co-treatment in hormone-replacement frozen embryo replacement cycles in women with polycystic ovary syndrome.

    Summary
    EudraCT number
    		 2009-017245-64
    Trial protocol
    		 GB  
    Global end of trial date
    13 May 2013

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Oct 2017
    First version publication date
    21 Oct 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    OG09/9146
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Leeds Teaching Hospitals
    Sponsor organisation address
    34 Hyde Terrace, Leeds, United Kingdom, LS9 6LN
    Public contact
    Professor Adam Balen, Leeds Teaching Hospitals, 0113 3926473, leedsth-tr.sponsorqa@nhs.net
    Scientific contact
    Professor Adam Balen, Professor Adam Balen, 0113 2063125, adam.balen@nhs.net
    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
    13 May 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    13 May 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    13 May 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Primary Outcome Measure: Live birth rate per frozen embryo replacement treatment cycle
    Protection of trial subjects
    GCP & reviewed by ethics & MRHA
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Dec 2010
    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: 33
    Worldwide total number of subjects
    33
    EEA total number of subjects
    33
    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)
    33
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruited 33 patients

    Pre-assignment
    Screening details
    		 -

    Pre-assignment period milestones
    Number of subjects started
    		 33
    Number of subjects completed

    Period 1
    Period 1 title
    overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Metformin
    Arm description
    		 -
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Metformin
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    850mg tablets twice daily

    Arm title
    		 Placebo
    Arm description
    		 -
    Arm type
    		 Placebo

    Investigational medicinal product name
    placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    one tablet twice daily

    Number of subjects in period 1
    		Metformin Placebo
    Started
    16
    17
    Completed
    15
    17
    Not completed
    1
    0
         Adverse event, non-fatal
    1
    -

    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
    		 33 33
    Age categorical
    women of reproductive age between 23-40 years old
    Units: Subjects
        Adults (18-64 years)
    		 33 33
    Gender categorical
    women undergoing Frozen embryo transfer cycle
    Units: Subjects
        Female
    		 33 33
    Subject analysis sets

    Subject analysis set title
    metformin
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per protocol

    Subject analysis set title
    Standard treatment per protocol
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per protocol

    Subject analysis sets values
    		 metformin Standard treatment per protocol
    Number of subjects
    16
    17
    Age categorical
    women of reproductive age between 23-40 years old
    Units: Subjects
        Adults (18-64 years)
    16
    17
    Age continuous
    Units:
        
    ±
    ±
    Gender categorical
    women undergoing Frozen embryo transfer cycle
    Units: Subjects
        Female
    16
    17

    End points

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

    Reporting group title
    Placebo
    Reporting group description
    		 -

    Subject analysis set title
    metformin
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per protocol

    Subject analysis set title
    Standard treatment per protocol
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Per protocol

    Primary: clinical pregnancy

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    End point title
    		 clinical pregnancy
    End point description
    End point type
    Primary
    End point timeframe
    30 months
    End point values
    		 Metformin Placebo metformin Standard treatment per protocol
    Number of subjects analysed
    16
    17
    16
    17
    Units: percentage
    16
    17
    16
    17
    Statistical analysis title
    		 Clinical pregnancy rate
    Comparison groups
    Placebo v Metformin
    Number of subjects included in analysis
    33
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.05
    Method
    		 t-test, 2-sided
    Confidence interval

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    30 months
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 NCRI Common Toxicity
    Dictionary version
    4
    Reporting groups
    Reporting group title
    Gi effects
    Reporting group description
    		 -

    Serious adverse events
    		 Gi effects
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 16 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 1%
    Non-serious adverse events
    		 Gi effects
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 16 (6.25%)
    Gastrointestinal disorders
    GI side effect
         subjects affected / exposed
    1 / 16 (6.25%)
         occurrences all number
    1

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    26 Mar 2010
    Protocol amended

    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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