Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43865   clinical trials with a EudraCT protocol, of which   7286   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Download PDF

    Clinical Trial Results:
    Eight weeks of androgen priming by hCG before IVF/ICSI in women with low ovarian reserve.

    Summary
    EudraCT number
    		 2020-002453-26
    Trial protocol
    		 DK  
    Global end of trial date
    01 Aug 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    21 Dec 2022
    First version publication date
    21 Dec 2022
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    73908
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT04643925
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    The Fertility Department, Rigshospitalet
    Sponsor organisation address
    Juliane Maries Vej 8, Copenhagen, Denmark, 2100
    Public contact
    Fertility Research , Rigshospitalet , fertilitet.rigshospitalet@regionh.dk
    Scientific contact
    Fertility Research , Rigshospitalet , fertilitet.rigshospitalet@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 Dec 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    01 Aug 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    01 Aug 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to investigate in a paired design if eight weeks of hCG pre-treatment improves responsiveness to ovarian stimulation during IVF/ICSI in women with low ovarian reserve.
    Protection of trial subjects
    Patients were asked about side effects at each trial visit.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    27 Dec 2020
    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
    Denmark: 20
    Worldwide total number of subjects
    20
    EEA total number of subjects
    20
    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)
    20
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 A total of 33 women were assessed for eligibility and 20 women were included. No patients were lost to follow up and data from all patients were included in the final analyses. Eligible women were recruited if they fulfilled the inclusion criteria and none of the exclusion criteria.

    Pre-assignment
    Screening details
    		 Patients in the fertility clinic were screened and offered to participate in the trial if they fulfilled the following inclusion criteria: - age 18-40 years - regular menstrual cycle between 23 and 35 days - Anti-Müllerian hormone (AMH) < 6.29 pmol/L measured within six months before inclusion

    Period 1
    Period 1 title
    Overall trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Arm title
    		 Whole trial
    Arm description
    		 All participants underwent the following: 1. A Control cycle: A standard IVF/ICSI cycle in the fixed GnRH-antagonist protocol using a daily dose of 300 IU rFSH initiated from cd 2-3 and the GnRH antagonist (Fyremadel 0.25 mg) from stimulation day 5-6 followed by blastocyst culture and a freeze-all strategy. 2. Followed by a ~60 day priming period with a daily dose of 260 IU hCG 3. Followed by a Study cycle: hCG priming by Ovitrelle 260 IE once daily for 8 weeks followed by a standard IVF/ICSI cycle in the fixed GnRH-antagonist protocol using a daily dose of 300 IU rFSH initiated from cd 2-3 and the GnRH antagonist (Fyremadel 0.25 mg) from stimulation day 5-6 followed by a single blastocyst transfer at day 5.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ovitrelle
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    1 daily injection of 260 IU Ovitrelle

    Number of subjects in period 1
    		Whole trial
    Started
    20
    Completed
    20

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Overall trial
    Reporting group description
    		 -

    Reporting group values
    		 Overall trial Total
    Number of subjects
    		 20 20
    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)
    		 0
        From 65-84 years
    		 0
        85 years and over
    		 0
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 36.8 ( 3.2 ) -
    Gender categorical
    All participants were female.
    Units: Subjects
        Female
    		 20 20
        Male
    		 0 0
    Menstrual cycle length
    Units: day
        arithmetic mean (standard deviation)
    		 26.2 ( 1.9 ) -

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Whole trial
    Reporting group description
    		 All participants underwent the following: 1. A Control cycle: A standard IVF/ICSI cycle in the fixed GnRH-antagonist protocol using a daily dose of 300 IU rFSH initiated from cd 2-3 and the GnRH antagonist (Fyremadel 0.25 mg) from stimulation day 5-6 followed by blastocyst culture and a freeze-all strategy. 2. Followed by a ~60 day priming period with a daily dose of 260 IU hCG 3. Followed by a Study cycle: hCG priming by Ovitrelle 260 IE once daily for 8 weeks followed by a standard IVF/ICSI cycle in the fixed GnRH-antagonist protocol using a daily dose of 300 IU rFSH initiated from cd 2-3 and the GnRH antagonist (Fyremadel 0.25 mg) from stimulation day 5-6 followed by a single blastocyst transfer at day 5.

    Subject analysis set title
    Control cycle
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All trial participants

    Subject analysis set title
    Study cycle
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    All study participants

    Primary: FORT

    		 Close Top of page
    End point title
    		 FORT
    End point description
    FORT, defined as the number of pre-ovulatory follicles (>16 mm) on hCG trigger day divided by the number of antral follicles (2-10 mm) at baseline.
    End point type
    Primary
    End point timeframe
    At the end of trial
    End point values
    		 Control cycle Study cycle
    Number of subjects analysed
    20 [1]
    20
    Units: Rate
        arithmetic mean (standard deviation)
    0.4 ( 0.4 )
    0.4 ( 0.2 )
    Notes
    [1] - All subjects in the trial
    Statistical analysis title
    		 Paired T-test
    Statistical analysis description
    Paired T-test for the difference in mean between FORT in the Control and Study cycle.
    Comparison groups
    Control cycle v Study cycle
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    P-value
    		 = 0.8
    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

    		 Close Top of page
    Adverse events information [1]
    Timeframe for reporting adverse events
    Until trial completion date.
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    25.1
    Reporting groups
    Reporting group title
    All participants
    Reporting group description
    		 -

    Serious adverse events
    		 All participants
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
         number of deaths (all causes)
    0
         number of deaths resulting from adverse events
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 All participants
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 20 (0.00%)
    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: None of the study participants experienced any serious adverse events in the trial.

    More information

    		 Close Top of page

    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.

    European Medicines Agency © 1995-Sat Apr 27 01:35:10 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA