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    Summary
    EudraCT Number:2022-003177-32
    Sponsor's Protocol Code Number:IBMR31
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2022-10-07
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSpain - AEMPS
    A.2EudraCT number2022-003177-32
    A.3Full title of the trial
    Continuous ovarian stimulation in DUOSTIM cycles.
    Estimulación ovárica continua en ciclos DUOSTIM.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Continuous double ovarian stimulation.
    Estimulación ovárica doble continua.
    A.4.1Sponsor's protocol code numberIBMR31
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorInstituto Bernabeu
    B.1.3.4CountrySpain
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportInstituto Bernabeu
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstituto Bernabeu
    B.5.2Functional name of contact pointResearch Project Coordinator
    B.5.3 Address:
    B.5.3.1Street AddressAv. Albufereta 31
    B.5.3.2Town/ cityAlicante
    B.5.3.3Post code03016
    B.5.3.4CountrySpain
    B.5.4Telephone number0034965154000
    B.5.5Fax number0034965151328
    B.5.6E-mailresearch@institutobernabeu.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Elonva
    D.2.1.1.2Name of the Marketing Authorisation holderN.V. Organon
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Patients with predictive indicators of low ovarian response and who undergo double ovarian stimulation (DUOSTIM).
    Pacientes con indicadores predictivos de baja respuesta ovárica y que realizan estimulación ovárica doble (DUOSTIM).
    E.1.1.1Medical condition in easily understood language
    Low ovarian response during the IVF treatment.
    Baja respuesta ovárica durante el tratamiento de FIV.
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the oocyte recovery rate after continuous use of corifolitropin alfa in DUOSTIM cycles (double consecutive ovarian stimulation: follicular and luteal phase in the same cycle).
    Valorar la tasa de recuperación ovocitaria tras el empleo continuo de corifolitropina alfa en ciclos DUOSTIM (doble estimulación ovárica consecutiva: fase folicular y lútea en un mismo ciclo).
    E.2.2Secondary objectives of the trial
    To evaluate: the rate of metaphase II oocytes, the duration of the ovarian stimulation and the fertilization rate.
    Evaluar: la tasa de ovocitos en estadio de metafase II, la duración de estimulación y la tasa de fecundación.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients with indication of DUOSTIM protocol. Maximum age 43 years (up to one day before turning 44 years old) at the beginning of the stimulation process. Ability to participate and to comply with the study protocol. To have given written consent.
    Pacientes con indicación de protocolo DUOSTIM. Edad máxima 43 años (hasta un día antes de cumplir 44 años) al inicio del proceso de estimulación. Capacidad para participar y cumplir con el protocolo del estudio. Haber dado su consentimiento por escrito.
    E.4Principal exclusion criteria
    Finding of ovarian pathology at the time of initiation of stimulation: e.g. ovarian cysts. Concurrent participation in another study.
    Hallazgo de patología ovárica en el momento de inicio de estimulación: e.g. quistes ováricos. Participación concurrente en otro estudio.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint of the efficacy results in this exploratory study will be the total number of oocytes obtained.
    La variable principal de evaluación de los resultados sobre eficacia en este estudio exploratorio será el número total de ovocitos obtenidos.
    E.5.1.1Timepoint(s) of evaluation of this end point
    Egg collection of the second ovarian stimulation in the DUOSTIM protocol.
    Recogida de óvulos de la segunda estimulación ovárica en el protocolo DUOSTIM.
    E.5.2Secondary end point(s)
    1. Total number of metaphase II oocyte. 2. Duration of stimulation (days). 3. Fertilization rate. 4. Total number of injectables received.
    1. Número total de ovocito metafase II. 2. Duración de la estimulación (días). 3. Tasa de fecundación. 4. Número total de inyectables recibidos.
    E.5.2.1Timepoint(s) of evaluation of this end point
    1, 2, 4: Egg collection of the second ovarian stimulation in the DUOSTIM protocol. 3: One day after the egg collection of the second ovarian stimulation in the DUOSTIM protocol.
    1, 2, 4: Recogida de óvulos de la segunda estimulación ovárica en el protocolo DUOSTIM. 3: Un día después de la recogida de óvulos de la segunda estimulación ovárica en el protocolo DUOSTIM.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety No
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Datos históricos de estimulación DUOSTIM "convencional" (con empleo de inyecciones diarias).
    Historical data of "conventional" DUOSTIM stimulation (using daily injections).
    E.8.2.4Number of treatment arms in the trial2
    E.8.3 The trial involves single site in the Member State concerned Yes
    E.8.4 The trial involves multiple sites in the Member State concerned No
    E.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    End of the trial considered the day when the last patient undergoes her second egg collection in the DUOSTIM protocol.
    El final del ensayo se considera el día en que la última paciente se sometA a la segunda recogida ovocitaria en el protocolo DUOSTIM.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years0
    E.8.9.1In the Member State concerned months6
    E.8.9.1In the Member State concerned days0
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 15
    F.1.3Elderly (>=65 years) No
    F.1.3.1Number of subjects for this age range: 0
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male No
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations No
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception No
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state15
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    The patient will be provided with the most suitable care after finishing the trial.
    El paciente recibirá los cuidados más adecuados tras finalizar el ensayo.
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2022-11-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-10-03
    P. End of Trial
    P.End of Trial StatusOngoing
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