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    Clinical Trial Results:
    Scheduling of GnRH antagonist FIV-ICSI cycles with estrogen or contraceptive oral pills in previous luteal phase. Comparison of results against no treatment.

    Summary
    EudraCT number
    		 2014-001809-40
    Trial protocol
    		 ES  
    Global end of trial date
    23 Jul 2018

    Results information
    Results version number
    		 v1(current)
    This version publication date
    01 Jan 2025
    First version publication date
    01 Jan 2025
    Other versions
    Summary report(s)
    		 Final results

    Trial information

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    Trial identification
    Sponsor protocol code
    MER001
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    IDIPAZ
    Sponsor organisation address
    Paseo castellana 261, MADRID, Spain,
    Public contact
    Sara Fernández Prada, Sara Fernández Prada Servicio de Reproducción Humana del Hospital la Paz, +34 606823685,
    Scientific contact
    Sara Fernández Prada, Sara Fernández Prada Servicio de Reproducción Humana del Hospital la Paz, 0034 606823685,
    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 Feb 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    23 Jul 2018
    Global end of trial reached?
    Yes
    Global end of trial date
    23 Jul 2018
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    Comparing gestational outcomes like pregnancy rate, clinical pregnancy rate, miscarriage rate or live birth rate between patients pretreated with estrogen pills, contraceptive pills and no pretreated .
    Protection of trial subjects
    NA
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    11 Nov 2015
    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: 106
    Worldwide total number of subjects
    106
    EEA total number of subjects
    106
    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)
    106
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 This is a prospective longitudinal interventional study in 3 cohorts in which we will compare patients undergoing IVF-ICSI treatment in protocol with compare patients undergoing IVF-ICSI treatment in protocol with antagonists who meet the inclusion and exclusion

    Pre-assignment
    Screening details
    		 patients randomized into three groups, group 1 pretreated with estradiol valerate, group 2 pretreated with oral contraceptives, group 3, no hormonal treatment in previous luteal phase

    Period 1
    Period 1 title
    period 1 (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 arm 1
    Arm description
    		 preconceptive treatment
    Arm type
    		 Active comparator

    Investigational medicinal product name
    levonorgestrel
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    oral contraceptive treatment arm (levonorgestrel 150 mcg/ ethinylestradiol 0.3 mcg) will start treatment on the 1st-2nd day of menstruation of the previous cycle for at least 12 days, with 5 days of washout thereafter, after which controlled ovarian stimulation will be initiated.

    Arm title
    		 arm 2
    Arm description
    		 oestradiol valerate
    Arm type
    		 Active comparator

    Investigational medicinal product name
    oestradiol valerate
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    treatment arm will start treatment 3 days before their expected period with a dose of 2 mg/12 hours until the day before the start of ovarian stimulation, which will begin between the 2nd-8th day of the cycle.

    Arm title
    		 arm 3
    Arm description
    		 no preatreatment
    Arm type
    		 No intervention

    Investigational medicinal product name
    No investigational medicinal product assigned in this arm
    Number of subjects in period 1
    		arm 1 arm 2 arm 3
    Started
    39
    32
    35
    Completed
    34
    25
    27
    Not completed
    5
    7
    8
         medication incompatibilities
    -
    -
    5
         Pregnancy
    -
    1
    1
         poor adherence
    2
    4
    -
         Lost to follow-up
    -
    1
    2
         patient decision
    3
    1
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    period 1
    Reporting group description
    		 -

    Reporting group values
    		 period 1 Total
    Number of subjects
    		 106 106
    Age categorical
    18-40 years
    Units: Subjects
        18-40
    		 0
    Age continuous
    18-40 years
    Units: years
        median (full range (min-max))
    		 35.35 (28 to 40) -
    Gender categorical
    Units: Subjects
        Female
    		 106 106
        Male
    		 0 0

    End points

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    End points reporting groups
    Reporting group title
    arm 1
    Reporting group description
    		 preconceptive treatment

    Reporting group title
    arm 2
    Reporting group description
    		 oestradiol valerate

    Reporting group title
    arm 3
    Reporting group description
    		 no preatreatment

    Primary: EVALUATE GESTATIONAL OUTCOMES

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    End point title
    		 EVALUATE GESTATIONAL OUTCOMES
    End point description
    To evaluate the gestational outcomes (clinical gestation rate, miscarriage and live birth) obtained in patients with a normo-responder profile, undergoing IVF-ICSI treatment in an antagonist protocol with pre-treatment in previous luteal phase (oestradiol valerate or combined oral contraceptives) versus the outcomes observed in patients without previous pre-treatment.
    End point type
    Primary
    End point timeframe
    during the study period
    End point values
    		 arm 1 arm 2 arm 3
    Number of subjects analysed
    34
    25
    27
    Units: %
    34
    25
    27
    Statistical analysis title
    		 Mean exposure time
    Comparison groups
    arm 3 v arm 1 v arm 2
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.078
    Method
    		 SD
    Parameter type
    		 standard deviation
    Confidence interval
    Statistical analysis title
    		 Mean exposure time
    Comparison groups
    arm 2 v arm 1 v arm 3
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.941
    Method
    		 SD
    Confidence interval
    Statistical analysis title
    		 no pretreatment
    Comparison groups
    arm 1 v arm 2 v arm 3
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    		 other [1]
    P-value
    		 = 0 [2]
    Method
    		 SD
    Confidence interval
    Notes
    [1] - NO AVAILABLE
    [2] - NOT AVAILABLE

    Secondary: To evaluate the number of ovarian follicles observed ultrasonographically at the end of the stimulation, the number of oocytes obtained, the oocyte maturity rate and the number of embryos evolved in the different study groups.

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    End point title
    		 To evaluate the number of ovarian follicles observed ultrasonographically at the end of the stimulation, the number of oocytes obtained, the oocyte maturity rate and the number of embryos evolved in the different study groups.
    End point description
    End point type
    Secondary
    End point timeframe
    during the hole study
    End point values
    		 arm 1 arm 2 arm 3
    Number of subjects analysed
    34
    25
    27
    Units: number
    34
    25
    27
    Statistical analysis title
    		 number of follicles SD
    Statistical analysis description
    NUMBER OF FOLLICLES > 16 mm on the day of the ovulatory trigger.
    Comparison groups
    arm 1 v arm 2 v arm 3
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.564
    Method
    		 SD
    Confidence interval

    Secondary: To evaluate the possible association of the exposure time to the different pretreatments with the reproductive results.

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    End point title
    		 To evaluate the possible association of the exposure time to the different pretreatments with the reproductive results.
    End point description
    End point type
    Secondary
    End point timeframe
    during the hole study
    End point values
    		 arm 1 arm 2 arm 3
    Number of subjects analysed
    34
    25
    27
    Units: days
    34
    25
    27
    Statistical analysis title
    		 GROUP PRETREATED WITH CONTRACEPTIVES
    Comparison groups
    arm 1 v arm 2
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.941
    Method
    		 SD
    Confidence interval
    Statistical analysis title
    		 GROUP PRETREATED WITH OESTROGENS
    Comparison groups
    arm 2 v arm 1
    Number of subjects included in analysis
    59
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.078
    Method
    		 SD
    Confidence interval

    Secondary: To assess the cancellation rate due to insufficient response or absence of viable embryos observed in the different study groups.

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    End point title
    		 To assess the cancellation rate due to insufficient response or absence of viable embryos observed in the different study groups.
    End point description
    End point type
    Secondary
    End point timeframe
    during the hole study
    End point values
    		 arm 1 arm 2 arm 3
    Number of subjects analysed
    34
    25
    27
    Units: %
    34
    25
    27
    Statistical analysis title
    		 cycle cancellation rate
    Comparison groups
    arm 1 v arm 2 v arm 3
    Number of subjects included in analysis
    86
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority
    P-value
    		 = 0.307
    Method
    		 SD
    Confidence interval

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    during the hole study
    Adverse event reporting additional description
    No clinically relevant alterations were found in phisical examination or vital signs. No side effects were reported. No adverse events were detected in the patients included in the study. There were no deaths, other serious adverse events or other significant adverse events during the study.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    20
    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: NO adverse events found

    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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