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    Clinical Trial Results:
    Randomized controlled trial comparing micronized progesterone (Amelgen ®) 400 mg BID versus 400 mg TID for luteal support in artificial vitrified/warmed single blastocyst transfer cycles with low progesterone on day of embryo transfer

    Summary
    EudraCT number
    		 2020-004112-10
    Trial protocol
    		 BE  
    Global end of trial date
    13 Jan 2025

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Jan 2026
    First version publication date
    11 Jan 2026
    Other versions
    Summary report(s)
    		 Final Study Report

    Trial information

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    Trial identification
    Sponsor protocol code
    PROTECTA
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    University Hospital Ghent
    Sponsor organisation address
    C. Heymanslaan 10, Gent, Belgium, 9000
    Public contact
    HIRUZ, Ghent University Hospital, +32 93320530, hiruz.ctu@uzgent.be
    Scientific contact
    HIRUZ, Ghent University Hospital, +32 93320530, hiruz.ctu@uzgent.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
    05 Dec 2025
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    13 Jan 2025
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to investigate the effect of an increased dose of vaginal progesterone supplementation (Amelgen ® 400 mg BID vs Amelgen ® 400 mg TID) on the ongoing pregnancy (fetal heartbeat during TVUS between week 6 and 8 of pregnancy) rate for patients undergoing IVF or ICSI treatment with a suboptimal serum progesterone level (defined as <10 mcg/l) on the day of blastocyst transfer in an artificial prepared endometrium cycle.
    Protection of trial subjects
    See attachment
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Apr 2021
    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: 268
    Worldwide total number of subjects
    268
    EEA total number of subjects
    268
    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)
    268
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 See attachment

    Pre-assignment
    Screening details
    		 See attachment

    Period 1
    Period 1 title
    Overal Study (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded
    Blinding implementation details
    See attachment

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Control Group
    Arm description
    		 See attachment
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Amelgen
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Vaginal gel
    Routes of administration
    Vaginal use
    Dosage and administration details
    See attachment

    Arm title
    		 Intervention Group
    Arm description
    		 See attachment
    Arm type
    		 Active comparator

    Investigational medicinal product name
    Amelgen
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Vaginal gel
    Routes of administration
    Vaginal use
    Dosage and administration details
    See attachment

    Investigational medicinal product name
    Amelgen
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Vaginal gel
    Routes of administration
    Vaginal use
    Dosage and administration details
    See attachment

    Number of subjects in period 1 [1]
    		Control Group Intervention Group
    Started
    85
    168
    Completed
    85
    168
    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: See attachment

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    Control Group
    Reporting group description
    		 See attachment

    Reporting group title
    Intervention Group
    Reporting group description
    		 See attachment

    Primary: Primary

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    End point title
    		 Primary [1]
    End point description
    See attachment
    End point type
    Primary
    End point timeframe
    During the study
    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: See attachment
    End point values
    		 Control Group Intervention Group
    Number of subjects analysed
    85 [2]
    168 [3]
    Units: Heart
        number (not applicable)
    85
    168
    Notes
    [2] - 85
    [3] - 168
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    During the study
    Adverse event reporting additional description
    See attachment
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    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: See attachment

    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
    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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