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    Clinical Trial Results:
    PROSPECTIVE AND RANDOMIZED STUDY FOR ASSESSMENT OF CONTROLLED OVARIAN STIMULATION WITH ALFA Corifollitropin IN PATIENTS WITH OVARIAN RESPONSE EXPECTED OR POOR IN VITRO FERTILIZATION CYCLE.

    Summary
    EudraCT number
    		 2013-002027-42
    Trial protocol
    		 ES  
    Global end of trial date
    24 Apr 2019

    Results information
    Results version number
    		 v1(current)
    This version publication date
    13 Feb 2022
    First version publication date
    13 Feb 2022
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    POR-ELONVA
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Instituto de Investigación Sanitaria La Fe de Valencia
    Sponsor organisation address
    Avenida Fernando Abril Martorell, Torre 106 A 7planta, 46026 València, , Valencia, Spain,
    Public contact
    UREC, INSTITUTO DE INVESTIGACION SANITARIA LA FE, 34 961246611, investigacion_clinica@iislafe.es
    Scientific contact
    UREC, INSTITUTO DE INVESTIGACION SANITARIA LA FE, 34 961246611, investigacion_clinica@iislafe.es
    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
    03 Apr 2019
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    03 Apr 2019
    Global end of trial reached?
    Yes
    Global end of trial date
    24 Apr 2019
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To investigate the efficiency of OVARTICA STIMULATION CONTROLLED by alpha Corifollitropin, in patients with expected or poor ovarian response undergoing IVF / ICSI.
    Protection of trial subjects
    The reference study was conducted in Spain under the legal framework of Royal Decree 1090/2015. It has been performed in accordance with the Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects, adopted by the General Assembly of the World Medical Association (1996). In addition, the study has been conducted in accordance with the protocol, good clinical practice (GCP) in accordance with the guidelines of the international conference on harmonization (ICH) and regulatory requirements for participating institutions. An appropriately performed informed consent has been used, in compliance with GCP according to ICH guidelines and approved by the CEIm of the Hospital Universitario y Politécnico La Fe. Prior to inclusion of subjects in the study, a copy of the CEIm-approved informed consent has been reviewed with the prospective participant, signed and dated. The investigator has provided a copy of each subject's signed informed consent form and has retained a copy in the subject's study file.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    01 Jul 2013
    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: 234
    Worldwide total number of subjects
    234
    EEA total number of subjects
    234
    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)
    234
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 The recruitment ended on 07 SEPTEMBRE 2016. A number of 234 patients were included, 221 patients completed all the study proceadures and 13 patients were excluded.

    Pre-assignment
    Screening details
    		 Patients ≥ 18 years of age, who have previously signed consent to participate. patients affected by subsidiary infertility who present one of the following factors: 1. history of surgical or medical treatment as a risk factor of POR. 2. poor ovarian response in response to EOC, 3 A poor ovarian response is expected due to abnormal ovarian reserve

    Pre-assignment period milestones
    Number of subjects started
    		 437 [1]
    Number of subjects completed
    		 234

    Pre-assignment subject non-completion reasons
    Reason: Number of subjects
    		 selection errors: 203
    Notes
    [1] - The number of subjects reported to have started the pre-assignment period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
    Justification: In the pre-assigned period, 437 patients were selected, of which 203 were unsuccessful, therefore, the number of patients who did continue in the clinical trial was 234
    Period 1
    Period 1 title
    Overall Trial (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Double blind
    Roles blinded
    		 Subject, Investigator
    Blinding implementation details
    The randomization will be carried out by the Pharmacy Service of the Hospital U. yP. of the Hospital U.yP. La Fe Hospital through the web page www.randomization.com . A randomization list will be generated. The block randomization method will be used in the 2 treatment arms and the treatment allocation sequence will be blinded to the investigator.

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Arm 1
    Arm description
    		 ELONVA® (CFA) + MENOPUR® HMG
    Arm type
    		 Experimental

    Investigational medicinal product name
    ELONVA®.
    Investigational medicinal product code
    CFA
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    250µg/24h from the day a follicle > 14mm is observed.

    Investigational medicinal product name
    MENOPUR®
    Investigational medicinal product code
    HMG
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    Dose: 300 IU/24h, if needed from the 8th day of EOC, until the hCG day.

    Investigational medicinal product name
    ORGALUTRAN®
    Investigational medicinal product code
    Ganirelix
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    250µg/24h from the day a follicle > 14mm is observed.

    Investigational medicinal product name
    OVITREL LE®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    6500 UI, single dose, when follicles > 17 mm are observed.

    Investigational medicinal product name
    UTROGESTAN®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Vaginal use
    Dosage and administration details
    400mg/24, from embryo transfer until the day of b hCG.

    Arm title
    		 Arm 2
    Arm description
    		 MENOPUR® HMG
    Arm type
    		 Experimental

    Investigational medicinal product name
    MENOPUR®
    Investigational medicinal product code
    HMG
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    300 IU/24h from the 2nd day of the cycle, during the whole stimulation.

    Investigational medicinal product name
    ORGALUTRAN®
    Investigational medicinal product code
    Ganirelix
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    250µg/24h from the day a follicle > 14mm is observed.

    Investigational medicinal product name
    OVITREL LE®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Solution for injection/infusion
    Routes of administration
    Subcutaneous use
    Dosage and administration details
    6500 UI, single dose, when follicles > 17 mm are observed.

    Investigational medicinal product name
    UTROGESTAN®
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, soft
    Routes of administration
    Vaginal use
    Dosage and administration details
    400mg/24, from embryo transfer until the day of b hCG.

    Number of subjects in period 1
    		Arm 1 Arm 2
    Started
    117
    117
    Completed
    112
    109
    Not completed
    5
    8
         Physician decision
    5
    8

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Arm 1
    Reporting group description
    		 ELONVA® (CFA) + MENOPUR® HMG

    Reporting group title
    Arm 2
    Reporting group description
    		 MENOPUR® HMG

    Reporting group values
    		 Arm 1 Arm 2 Total
    Number of subjects
    		 117 117 234
    Age categorical
    Units: Subjects
        >18
    		 112 109 221
        Not recording
    		 5 8 13
    Gender categorical
    Taking into account the equivalence and safety profile of CFA corifollitropin alfa, the active ingredient of ELONVA ®), a systematic review and meta-analysis and a Cochrane review conclude that, appears to be an alternative to daily rFSH injections in normoresponders undergoing ovarian stimulation in IVF/ICSI treatment cycles. but more is needed research to determine if long-acting FSH is safe and effective for use in low and high responder women
    Units: Subjects
        Female
    		 117 117 234

    End points

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    End points reporting groups
    Reporting group title
    Arm 1
    Reporting group description
    		 ELONVA® (CFA) + MENOPUR® HMG

    Reporting group title
    Arm 2
    Reporting group description
    		 MENOPUR® HMG

    Primary: % Ongoing pregnancy rate

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    End point title
    		 % Ongoing pregnancy rate
    End point description
    End point type
    Primary
    End point timeframe
    20-24 weeks
    End point values
    		 Arm 1 Arm 2
    Number of subjects analysed
    112
    109
    Units: mean
    arithmetic mean (standard deviation)
        started cycle
    15.2 ( 0.33 )
    20.2 ( 0.33 )
        ocytes retrieval
    15.7 ( 0.29 )
    21.4 ( 0.29 )
        embryo transfer
    22.4 ( 0.30 )
    29.7 ( 0.30 )
    Statistical analysis title
    		 Ongoing pregnancy and LBR
    Comparison groups
    Arm 1 v Arm 2
    Number of subjects included in analysis
    221
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [1]
    P-value
    		 < 0.05
    Method
    		 Chi-squared
    Parameter type
    		 Median difference (final values)
    Point estimate
    -5
    Confidence interval
         level
    		 95%
         sides
    2-sided
         lower limit
    		 -15.1
         upper limit
    		 5
    Variability estimate
    Standard deviation
    Dispersion value
    0.33
    Notes
    [1] - The primary outcome was ongoing pregnancy rate (20-24 weeks). Additionally, due to the long and slow process of recruiting patients, we have also been able to obtain the current birth rate.

    Secondary: Stimulation characteristic

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    End point title
    		 Stimulation characteristic
    End point description
    End point type
    Secondary
    End point timeframe
    cycle otucome
    End point values
    		 Arm 1 Arm 2
    Number of subjects analysed
    112
    109
    Units: mean
    arithmetic mean (standard deviation)
        Cancelled cycles before OR, n(%)
    4 ( 3.6 )
    6 ( 5.5 )
        Duration of COS (days)
    10.4 ( 1.99 )
    9.9 ( 2.07 )
        Cycles with COS > 7 days, n (%)
    105 ( 93.8 )
    100 ( 91.7 )
        Dose hp-hMG (IU) form 8º Day COS
    1070.8 ( 546.13 )
    899.3 ( 600.43 )
        E2 Day hCG (pg/ml)
    1320 ( 634.20 )
    1611 ( 765.4 )
        P day hCG (ng/ml)
    1 ( 0.51 )
    0.8 ( 0.44 )
        Endometrial thickness day hCG (mm)
    9.9 ( 1.7 )
    9.9 ( 1.65 )
        Total follicles day hCG
    8.2 ( 3.60 )
    8.5 ( 3.63 )
    Statistical analysis title
    		 Cycle outcomes
    Comparison groups
    Arm 1 v Arm 2
    Number of subjects included in analysis
    221
    Analysis specification
    Pre-specified
    Analysis type
    		 non-inferiority [2]
    P-value
    		 < 0.05
    Method
    		 Fisher exact
    Parameter type
    		 Median difference (final values)
    Confidence interval
    Notes
    [2] - There were differences in the mean duration of the days of stimulation, hp-hMG doses from the 8th day of the COS, E2 levels and progesterone levels on the day of hCG, between the study groups. No significant differences were observed in other efficacy endpoints measures.

    Secondary: Results of the cycle and laboratory

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    End point title
    		 Results of the cycle and laboratory
    End point description
    End point type
    Secondary
    End point timeframe
    Serum hCG 15 days after follicular puncture and demonstration of the presence of intrauterine gestational sac with heartbeat, by transvaginal ultrasound, 15 days after positive determination of β hCG.
    End point values
    		 Arm 1 Arm 2
    Number of subjects analysed
    112
    109
    Units: number
        Cycles with OR, n (%)
    108
    103
        Nº of aspirated follicles
    6
    6
        Nº of oocytes retrieved
    4
    5
        Nº of mature oocyte (MII)
    3
    4
        Fertilization rate
    65
    63
        Nº of embryos on D +2/3
    2
    2
        Nº of embryos transferred
    2
    2
        Top quality embryos transferred
    1
    1
        cycles with ET n (%)
    76
    74
        Ciclyes with vitrified embryos n(%)
    9
    18
    No statistical analyses for this end point

    Secondary: Pregnancy outcome

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    End point title
    		 Pregnancy outcome
    End point description
    End point type
    Secondary
    End point timeframe
    Pregnancy outcomes
    End point values
    		 Arm 1 Arm 2
    Number of subjects analysed
    112
    109
    Units: Number
        Biochemical pregnancy, n
    23
    27
        Clinical pregnancy, n
    21
    26
        Ongoing pregnancy and liver Birth, n
    17
    22
        Miscarriage m (%)
    6
    5
    No statistical analyses for this end point

    Secondary: Cumulatie pregnancy

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    End point title
    		 Cumulatie pregnancy
    End point description
    End point type
    Secondary
    End point timeframe
    gestation > 20 week.
    End point values
    		 Arm 1 Arm 2
    Number of subjects analysed
    112
    109
    Units: Percentage
        Ongoing pregnancy and LBR/ cycle, %
    15
    24
        Ongoing pregnancy and LBR/ OR %
    16
    22
        Onoing pregnancy and LBR/ ET %
    21
    23
        Miscarriage rate, n(%)
    7
    30
    No statistical analyses for this end point

    Adverse events

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    Adverse events information [1]
    Timeframe for reporting adverse events
    All events that meet the definition of an AE and occur within the period from the time the patient signs the informed consent form until 28 days after the end of treatment should be recorded.
    Assessment type
    		 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: No ectopic gestations and no adverse secondary effects to ovarian stimulation were observed in any of those in either study group.

    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

    Online references
    http://www.ncbi.nlm.nih.gov/pubmed/30428403
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