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    Clinical Trial Results:
    Estradiol levels in early pregnancy after natural, estradiol + progesterone or gonadotrophin stimulated frozen embryo transfer (FET) cycle

    Summary
    EudraCT number
    		 2020-001218-39
    Trial protocol
    		 DK  
    Global end of trial date
    06 Dec 2024

    Results information
    Results version number
    		 v1(current)
    This version publication date
    19 Nov 2025
    First version publication date
    19 Nov 2025
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    svenne0405
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Herlev Hospital
    Sponsor organisation address
    Borgmester Ib Juuls vej 9, Herlev, Denmark, 2730
    Public contact
    Fertility clinic Herlev University , Fertility clinic Herlev University Hospital, pernille.fog.svendsen@regionh.dk
    Scientific contact
    Fertility clinic Herlev University , Fertility clinic Herlev University Hospital, +45 26208702, pernille.fog.svendsen@regionh.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
    01 May 2025
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    06 Dec 2024
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Dec 2024
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate plasma estradiol and progesterone levels in early pregnancy in women who have conceived after transfer of thawed blastocysts in an either natural or hormonstimulated cycle.
    Protection of trial subjects
    Not relevant for this study
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    20 Apr 2021
    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: 305
    Worldwide total number of subjects
    305
    EEA total number of subjects
    305
    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)
    305
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Patients were recruited from The Fertility Clinic at Herlev University Hospital from april 2021 untill December 2024

    Pre-assignment
    Screening details
    		 Patients could could participate in the study if they had frozen blastocysts. Inclusion criteria: Age > 18 years < 40 years BMI < 35 kg/m2 Normal wet smear within the past three years Thawed blastocysts (day 5) after either IVF or ICSI treatment Exclusion criteria: Age < 18 years BMI > 35 kg/m2 Day 6 blastocysts Oocyte donation

    Pre-assignment period milestones
    Number of subjects started
    		 305
    Number of subjects completed
    		 305

    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
    		 modified natrural cycle for ovulatory women
    Arm description
    		 FET in a natural cycle with ovulation trigger
    Arm type
    		 Active comparator

    Investigational medicinal product name
    ovitrelle
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled syringe
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    250 mic grams One injection

    Arm title
    		 programmed cycle for ovulatory women
    Arm description
    		 Estradiol and progesterone administartion
    Arm type
    		 Active comparator

    Investigational medicinal product name
    estradiol
    Investigational medicinal product code
    Other name
    østradiol
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    6-8 mg daily

    Investigational medicinal product name
    cyclogest
    Investigational medicinal product code
    progesterone
    Other name
    Pharmaceutical forms
    Vaginal tablet
    Routes of administration
    Vaginal use, Rectal use
    Dosage and administration details
    400 mg three times daily

    Arm title
    		 gondotrophin stimulated cycle for anovulatory women
    Arm description
    		 FET using gonadotrophin stimulation and ovulation trigger
    Arm type
    		 Active comparator

    Investigational medicinal product name
    bemfola
    Investigational medicinal product code
    recombinant follitropin alpha
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    50 - 75 IU starting dose increasing until follicular growth

    Investigational medicinal product name
    ovitrelle
    Investigational medicinal product code
    HCG
    Other name
    Pharmaceutical forms
    Suspension for injection in pre-filled pen
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    250 mic grams once

    Arm title
    		 programmed cycle for anovulatory women
    Arm description
    		 Estradiol and progesterone administration
    Arm type
    		 Active comparator

    Investigational medicinal product name
    estradiol
    Investigational medicinal product code
    Other name
    østradiol
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    6-8 mg daily

    Investigational medicinal product name
    cyclogest
    Investigational medicinal product code
    Other name
    progesterone
    Pharmaceutical forms
    Vaginal tablet
    Routes of administration
    Vaginal use, Rectal use
    Dosage and administration details
    400 mg three times daily

    Number of subjects in period 1
    		modified natrural cycle for ovulatory women programmed cycle for ovulatory women gondotrophin stimulated cycle for anovulatory women programmed cycle for anovulatory women
    Started
    116
    116
    36
    37
    Completed
    102
    107
    31
    33
    Not completed
    14
    9
    5
    4
         Protocol deviation
    14
    9
    5
    4

    Baseline characteristics

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    End points

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    End points reporting groups
    Reporting group title
    modified natrural cycle for ovulatory women
    Reporting group description
    		 FET in a natural cycle with ovulation trigger

    Reporting group title
    programmed cycle for ovulatory women
    Reporting group description
    		 Estradiol and progesterone administartion

    Reporting group title
    gondotrophin stimulated cycle for anovulatory women
    Reporting group description
    		 FET using gonadotrophin stimulation and ovulation trigger

    Reporting group title
    programmed cycle for anovulatory women
    Reporting group description
    		 Estradiol and progesterone administration

    Primary: Estradiol levels

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    End point title
    		 Estradiol levels
    End point description
    End point type
    Primary
    End point timeframe
    20/4-2021-6/12-2024
    End point values
    		 modified natrural cycle for ovulatory women programmed cycle for ovulatory women gondotrophin stimulated cycle for anovulatory women programmed cycle for anovulatory women
    Number of subjects analysed
    102
    107
    31
    33
    Units: nmol/l
        number (not applicable)
    102
    107
    31
    33
    Statistical analysis title
    		 Welch’s two-sample t-test or Mann–Whitney
    Statistical analysis description
    Comparisons between treatment groups of reproductive outcomes and obstetric data were performed by Welch’s two-sample t-test or Mann–Whitney test for continuous data and by Fisher’s exact test for categorical data. We used a linear mixed model (LMM) including GA (categorical as visits) as a fixed effect to analyze changes in estradiol and progesterone over time. T
    Comparison groups
    modified natrural cycle for ovulatory women v programmed cycle for ovulatory women v gondotrophin stimulated cycle for anovulatory women v programmed cycle for anovulatory women
    Number of subjects included in analysis
    273
    Analysis specification
    Pre-specified
    Analysis type
    		 superiority
    P-value
    		 < 0.05
    Method
    		 t-test, 2-sided
    Parameter type
    		 Mean difference (final values)
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -
         upper limit
    		 -
    Variability estimate
    Standard deviation

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Treatment start until one week after administration of the last dose of study medication
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    1
    Reporting groups
    Reporting group title
    Modified natural cycle
    Reporting group description
    		 -

    Serious adverse events
    		 Modified natural cycle
    Total subjects affected by serious adverse events
         subjects affected / exposed
    1 / 102 (0.98%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Pregnancy, puerperium and perinatal conditions
    Ectopic pregnancy
    Additional description: Treated by standard protocol
         subjects affected / exposed
    1 / 102 (0.98%)
         occurrences causally related to treatment / all
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 1.5%
    Non-serious adverse events
    		 Modified natural cycle
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    30 / 102 (29.41%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    30 / 102 (29.41%)
         occurrences all number
    30

    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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