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    Clinical Trial Results:
    Impact of luteal phase support with vaginal progesterone on the clinical pregnancy rate in IUI cycles stimulated with gonadotrophins: a prospective randomized multicentre study.

    Summary
    EudraCT number
    		 2010-023867-17
    Trial protocol
    		 BE  
    Global end of trial date
    22 Oct 2015

    Results information
    Results version number
    		 v1(current)
    This version publication date
    14 Feb 2021
    First version publication date
    14 Feb 2021
    Other versions
    Summary report(s)
    		 Publication

    Trial information

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    Trial identification
    Sponsor protocol code
    S52775
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01826747
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    UZLeuven
    Sponsor organisation address
    Herestraat 49, Leuven, Belgium, 3000
    Public contact
    Karen Peeraer, UZLeuven, +32 16343650, karen.peeraer@uzleuven.be
    Scientific contact
    Karen Peeraer, UZLeuven, +32 16343650, karen.peeraer@uzleuven.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
    22 Oct 2015
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Oct 2015
    Global end of trial reached?
    Yes
    Global end of trial date
    22 Oct 2015
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    Test the hypothesis that luteal phase support with vaginal progesterone leads to a higher clinical pregnancy rate when compared to no luteal phase support in a program of intrauterine insemination after controlled ovarian stimulation with gonadotrophins
    Protection of trial subjects
    No measurements were taken. Study did not cause additional pain or distress.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Apr 2011
    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: 393
    Worldwide total number of subjects
    393
    EEA total number of subjects
    393
    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)
    393
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 All couples with an indication for intrauterine insemination (IUI) such as unexplained infertility, mild male factor infertility, or minimal�mild endometriosis were eligible for this study during their first IUI cycle. Before their inclusion in the study, all couples underwent a complete infertility evaluation.

    Pre-assignment
    Screening details
    		 first IUI cycle Physical examination, medical history check serum hormone assay between day 2 and 5 of menstrual cycle pelvic ultrasound assessment of tubal patency either by hysterosalpingography or laparoscopy, and semen analysis <43 years old, BMI =<30 at least one patent tube partner sperm motile of >= 5 million

    Period 1
    Period 1 title
    overall trial (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 group without luteal phase support
    Arm description
    		 control group: standard of care intrauterine insemination
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Arm title
    		 study group with luteal phase support
    Arm description
    		 study group with luteal phase support. Vaginal progesterone gel used
    Arm type
    		 Experimental

    Investigational medicinal product name
    Crinone
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Gel
    Routes of administration
    Vaginal use
    Dosage and administration details
    once daily in the morning starting on the day after IUI until the time of pregnancy test (b-hCG) about 15 days after IUI. Crinone was administered by an applicator that delivered 1.125 g of vaginal gel containing 90 mg of progesterone.

    Number of subjects in period 1
    		control group without luteal phase support study group with luteal phase support
    Started
    191
    202
    Completed
    177
    187
    Not completed
    14
    15
         Physician decision
    6
    3
         Pregnancy
    5
    7
         patient decision
    2
    4
         Protocol deviation
    1
    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
    		 393 393
    Age categorical
    Female subjects age: 18-42 year
    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)
    		 0 0
        From 65-84 years
    		 0 0
        85 years and over
    		 0 0
        Female 18-42 years
    		 393 393
    Gender categorical
    Units: Subjects
        Female
    		 393 393
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    control group without luteal phase support
    Reporting group description
    		 control group: standard of care intrauterine insemination

    Reporting group title
    study group with luteal phase support
    Reporting group description
    		 study group with luteal phase support. Vaginal progesterone gel used

    Primary: Clinical pregnancy rate

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    End point title
    		 Clinical pregnancy rate [1]
    End point description
    End point type
    Primary
    End point timeframe
    Primary endpoint is clinical pregnancy rate. 34 of the 202 patients in the study group became pregnant (16.8%). 21 of the 191 patients in the control group became pregnant (11%)
    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: not specified in publication
    End point values
    		 control group without luteal phase support study group with luteal phase support
    Number of subjects analysed
    191
    202
    Units: 34
    21
    34
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    Safety was not an endpoint of the study.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.0
    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: adverse events not collected

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/27565253
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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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