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    Clinical Trial Results:
    Conventional ovarian stimulation vs. stimulation with single injection of Corifollitropin alfa in oocyte donors. Randomized clinical trial. Tail Studio

    Summary
    EudraCT number
    		 2019-001343-44
    Trial protocol
    		 ES  
    Global end of trial date
    08 May 2021

    Results information
    Results version number
    		 v1(current)
    This version publication date
    27 Aug 2022
    First version publication date
    27 Aug 2022
    Other versions
    Summary report(s)
    		 2019-001343-44

    Trial information

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    Trial identification
    Sponsor protocol code
    IB-0319-002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT03939403
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Instituto Bernabeu
    Sponsor organisation address
    Av. Albufereta 31, Alicante, Spain, 03016
    Public contact
    Anna Pitas, Instituto Bernabeu, 34 965154000, apitas@institutobernabeu.com
    Scientific contact
    Anna Pitas, Instituto Bernabeu, 34 965154000, apitas@institutobernabeu.com
    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
    16 Feb 2022
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    22 Mar 2021
    Global end of trial reached?
    Yes
    Global end of trial date
    08 May 2021
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To study the efficiency of the use of a single injection of CFA for ovarian stimulation, initiating administration late and without further contribution of FSH activity after the 7th day of stimulation compared to conventional EOC using CFA (administration of the drug 5 days after cesar hormonal contraceptive and supplementation with FSH daily administration from the 8th day of stimulation).
    Protection of trial subjects
    Measures as per usual clinical practice.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    03 Jun 2019
    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
    Spain: 180
    Worldwide total number of subjects
    180
    EEA total number of subjects
    180
    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)
    180
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment among the oocyte donors at our clinic.

    Pre-assignment
    Screening details
    		 Completion of the screening criteria, normal ultrasound scan and normal hormonal analysis results.

    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
    Arm description
    		 The used treatment is identical in both arms. The difference between the groups is the moment of beginning of the stimulation as well as the later administration of more FSH activity: The control group receives the treatment on the 5th day after the cessation of hormonal contraceptive use and also receives additional FSH.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    ELONVA
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    SINGLE SUBCUTANEOUS INJECTION, 250 mcg ofcorifolitropine alfa

    Arm title
    		 study group
    Arm description
    		 The used treatment is identical in both arms. The difference between the groups is the moment of beginning of the stimulation as well as the later administration of more FSH activity: The intervention group receives the treatment on the 7th day after the cessation of hormonal contraceptive use and does not receive additional FSH.
    Arm type
    		 Experimental

    Investigational medicinal product name
    ELONVA
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Injection
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    SINGLE SUBCUTANEOUS INJECTION, 250 mcg ofcorifolitropine alfa

    Number of subjects in period 1
    		control group study group
    Started
    90
    90
    Completed
    81
    68
    Not completed
    9
    22
         Physician decision
    9
    11
         Covid
    -
    3
         Lost to follow-up
    -
    8

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    control group
    Reporting group description
    		 The used treatment is identical in both arms. The difference between the groups is the moment of beginning of the stimulation as well as the later administration of more FSH activity: The control group receives the treatment on the 5th day after the cessation of hormonal contraceptive use and also receives additional FSH.

    Reporting group title
    study group
    Reporting group description
    		 The used treatment is identical in both arms. The difference between the groups is the moment of beginning of the stimulation as well as the later administration of more FSH activity: The intervention group receives the treatment on the 7th day after the cessation of hormonal contraceptive use and does not receive additional FSH.

    Reporting group values
    		 control group study group Total
    Number of subjects
    		 90 90 180
    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)
    		 24.52 ± 6.26 24.52 ± 5.69 -
    Gender categorical
    Units: Subjects
        Female
    		 90 90 180
        Male
    		 0 0 0
    Subject analysis sets

    Subject analysis set title
    Tail
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All oocyte donors included in the study were healthy women 18 - 32 years, with body mass index between 18 and 29 kg/m2, an antral follicle count (AFC) > 12, both ovaries present, with regular menstrual cycles and recruited according to the clinical and legal requirements of the Spanish Act for Assisted Human Reproduction: Reproductive Act (RD 9/2014) which includes: a psychological interview, gynecological examination and a rigorous screening for infectious diseases and genetic abnormalities. Donors signed the corresponding informed consent form during enrollment.

    Subject analysis sets values
    		 Tail
    Number of subjects
    149
    Age categorical
    Units: Subjects
        In utero
        Preterm newborn infants (gestational age < 37 wks)
        Newborns (0-27 days)
        Infants and toddlers (28 days-23 months)
        Children (2-11 years)
        Adolescents (12-17 years)
        Adults (18-64 years)
        From 65-84 years
        85 years and over
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    24.52 ± 5.97
    Gender categorical
    Units: Subjects
        Female
    180
        Male
    0

    End points

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    End points reporting groups
    Reporting group title
    control group
    Reporting group description
    		 The used treatment is identical in both arms. The difference between the groups is the moment of beginning of the stimulation as well as the later administration of more FSH activity: The control group receives the treatment on the 5th day after the cessation of hormonal contraceptive use and also receives additional FSH.

    Reporting group title
    study group
    Reporting group description
    		 The used treatment is identical in both arms. The difference between the groups is the moment of beginning of the stimulation as well as the later administration of more FSH activity: The intervention group receives the treatment on the 7th day after the cessation of hormonal contraceptive use and does not receive additional FSH.

    Subject analysis set title
    Tail
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All oocyte donors included in the study were healthy women 18 - 32 years, with body mass index between 18 and 29 kg/m2, an antral follicle count (AFC) > 12, both ovaries present, with regular menstrual cycles and recruited according to the clinical and legal requirements of the Spanish Act for Assisted Human Reproduction: Reproductive Act (RD 9/2014) which includes: a psychological interview, gynecological examination and a rigorous screening for infectious diseases and genetic abnormalities. Donors signed the corresponding informed consent form during enrollment.

    Primary: number of MII oocytes retrieved

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    End point title
    		 number of MII oocytes retrieved
    End point description
    End point type
    Primary
    End point timeframe
    This variable is assesed at the end of the patients' treatments, on the egg retrieval day.
    End point values
    		 control group study group
    Number of subjects analysed
    81
    68
    Units: oocyte
    13
    9
    Attachments
    		 MII oocyte number
    Statistical analysis title
    		 Wilcoxon rank sum test
    Statistical analysis description
    For the univariate statistical analysis of qualitative variables, the Chi - square test or Fisher's exact test will be used. For evaluation of normal distributions, the Shapiro – Wilk’s test was performed. Depending on whether the variable has a normal distribution, the comparison between means was carried out using Student’s t test or Wilcoxon rank sum test. Values of p < 0.05 will be considered statistically significant.
    Comparison groups
    control group v study group
    Number of subjects included in analysis
    149
    Analysis specification
    Post-hoc
    Analysis type
    		 non-inferiority
    P-value
    		 < 0.05
    Method
    		 Wilcoxon (Mann-Whitney)
    Parameter type
    		 Mean difference (final values)
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    between the start of the trial and the last visit of the last patient.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 no specific dictiona
    Dictionary version
    1
    Frequency threshold for reporting non-serious adverse events: 0.05%
    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: Only approved medication was used in the trial. This medication is used frequently in ovarian stimulation protocols and it is well tolerated by the patients.

    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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