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    Clinical Trial Results:
    Optimizing serum progesterone level during luteal phase in hormone replacement therapy frozen embryo transfer (HRT-FET) cycle – interventional and observational trial

    Summary
    EudraCT number
    		 2019-001539-29
    Trial protocol
    		 DK  
    Global end of trial date
    20 Dec 2022

    Results information
    Results version number
    		 v1(current)
    This version publication date
    07 Sep 2023
    First version publication date
    07 Sep 2023
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    alsbjerg1
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    The Fertility Clinic, Skive Regional Hospital
    Sponsor organisation address
    Resenvej 25, Skive, Denmark, 7800
    Public contact
    The Fertility Clinic, Skive Regiona, The Fertility Clinic, Skive Regional Hospital, +45 78445760, birgit.alsbjerg@midt.rm.dk
    Scientific contact
    The Fertility Clinic, Skive Regiona, The Fertility Clinic, Skive Regional Hospital, +45 78445760, birgit.alsbjerg@midt.rm.dk
    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
    20 Mar 2023
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    20 Dec 2022
    Global end of trial reached?
    Yes
    Global end of trial date
    20 Dec 2022
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The aim of this study is to investigate the effect of adding progesterone rectally in hormone replacement treatment frozen embryo transfer (HRT-FET) cycles if the serum progesterone (P4) is <35nmol/l on embryo transfer day.
    Protection of trial subjects
    The study was approved by the scientific Ethics Committee of the Central Denmark Region – Project number: M-2019-200-19 Written informed consent was obtained from all participants prior to inclusion
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    02 Jan 2020
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Denmark: 488
    Worldwide total number of subjects
    488
    EEA total number of subjects
    488
    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)
    488
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The first patient was enrolled in January 2020 and the last patient was enrolled in September 2022

    Pre-assignment
    Screening details
    		 A total of 607 patients were assessed for eligibility and 488 patients were subsequently recruited. No patient was lost to follow-up

    Period 1
    Period 1 title
    Overall period
    Is this the baseline period?
    		 Yes
    Allocation method
    Non-randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Group <35 nmol/l
    Arm description
    		 HRT treatment including 6 mg estradiol (Estrofem) and vaginally progesterone (Cyclogest) 400 mg twice a day. If serum P4 is <35 nmol/l at the day of embryo transfer the progesterone regime is changed to 400 mg vaginally Cyclogest and additional 400 mg Cyclogest administered rectally starting at the day of transfer.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Cyclogest
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suppository
    Routes of administration
    Rectal use
    Dosage and administration details
    (400mg/12hour starting that same day as embryo transfer. In pregnant patients, rectal administration continued until week 8 of gestation.

    Arm title
    		 Group >35 nmol/l
    Arm description
    		 HRT treatment including 6 mg estradiol (Estrofem) and vaginally progesterone (Cyclogest) 400 mg twice a day
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		Group <35 nmol/l Group >35 nmol/l
    Started
    114
    374
    Completed
    114
    374

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group <35 nmol/l
    Reporting group description
    		 HRT treatment including 6 mg estradiol (Estrofem) and vaginally progesterone (Cyclogest) 400 mg twice a day. If serum P4 is <35 nmol/l at the day of embryo transfer the progesterone regime is changed to 400 mg vaginally Cyclogest and additional 400 mg Cyclogest administered rectally starting at the day of transfer.

    Reporting group title
    Group >35 nmol/l
    Reporting group description
    		 HRT treatment including 6 mg estradiol (Estrofem) and vaginally progesterone (Cyclogest) 400 mg twice a day

    Reporting group values
    		 Group <35 nmol/l Group >35 nmol/l Total
    Number of subjects
    		 114 374 488
    Age categorical
    Units: Subjects
        In utero
    		 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    		 0 0 0
        Newborns (0-27 days)
    		 0 0 0
        Infants and toddlers (28 days-23 months)
    		 0 0 0
        Children (2-11 years)
    		 0 0 0
        Adolescents (12-17 years)
    		 0 0 0
        Adults (18-64 years)
    		 114 374 488
        From 65-84 years
    		 0 0 0
        85 years and over
    		 0 0 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 30.9 ( 4.6 ) 30.9 ( 4.6 ) -
    Gender categorical
    Units: Subjects
        Female
    		 114 374 488
        Male
    		 0 0 0
    Subject analysis sets

    Subject analysis set title
    Full analysis
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The primary analysis was the full analysis of all includede patients having an embryo transfer.

    Subject analysis sets values
    		 Full analysis
    Number of subjects
    488
    Age categorical
    Units: Subjects
        In utero
    0
        Preterm newborn infants (gestational age < 37 wks)
    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)
    488
        From 65-84 years
    0
        85 years and over
    0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    30.9 ( 4.6 )
    Gender categorical
    Units: Subjects
        Female
    488
        Male
    0

    End points

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    End points reporting groups
    Reporting group title
    Group <35 nmol/l
    Reporting group description
    		 HRT treatment including 6 mg estradiol (Estrofem) and vaginally progesterone (Cyclogest) 400 mg twice a day. If serum P4 is <35 nmol/l at the day of embryo transfer the progesterone regime is changed to 400 mg vaginally Cyclogest and additional 400 mg Cyclogest administered rectally starting at the day of transfer.

    Reporting group title
    Group >35 nmol/l
    Reporting group description
    		 HRT treatment including 6 mg estradiol (Estrofem) and vaginally progesterone (Cyclogest) 400 mg twice a day

    Subject analysis set title
    Full analysis
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    The primary analysis was the full analysis of all includede patients having an embryo transfer.

    Primary: Ongoing pregnancy

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    End point title
    		 Ongoing pregnancy
    End point description
    End point type
    Primary
    End point timeframe
    12 weeks
    End point values
    		 Group <35 nmol/l Group >35 nmol/l
    Number of subjects analysed
    114
    374
    Units: percent
        number (not applicable)
    46
    45
    Statistical analysis title
    		 X^2 test
    Comparison groups
    Group <35 nmol/l v Group >35 nmol/l
    Number of subjects included in analysis
    488
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 t-test, 1-sided
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    14 weeks
    Adverse event reporting additional description
    No adverse events were reported during the study.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    23
    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: There was no non-serious adverse events. However, few side effects do to discharge.

    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
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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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