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    Summary
    EudraCT Number:2019-001342-18
    Sponsor's Protocol Code Number:IB-0319-001
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2019-04-30
    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 number2019-001342-18
    A.3Full title of the trial
    CONVENTIONAL STIMULATION IN FOLICULAR PHASE VS. STIMULATION IN LUTEA PHASE IN PATIENTS WITH SUBOPTIMA RESPONSE. RANDOMIZED CLINICAL TRIAL. SUBLUTEAL STUDY
    ESTIMULACIÓN CONVENCIONAL EN FASE FOLICULAR VS. ESTIMULACIÓN EN FASE LUTEA EN PACIENTES CON RESPUESTA SUBOPTIMA. ENSAYO CLÍNICO RANDOMIZADO. ESTUDIO SUBLUTEAL
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of the number of oocytes obtained by performing ovarian stimulation at the time of the menstrual cycle that is usually done with performing it at a later stage of the cycle in patients who have previously had a poor response
    Comparación del número de ovocitos obtenidos realizando la estimulación ovárica en el momento del ciclo menstrual que suele hacerse habitualmente con realizarla en un momento más avanzado del ciclo en pacientes que ha tenido previamente una respuesta pobre
    A.3.2Name or abbreviated title of the trial where available
    ESTUDIO SUBLUTEAL
    A.4.1Sponsor's protocol code numberIB-0319-001
    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.4.1Name of organisation providing supportMSD España
    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 pointAnna Pitas
    B.5.3 Address:
    B.5.3.1Street AddressAvda. Albufereta, 31
    B.5.3.2Town/ cityAlicante
    B.5.3.3Post code03016
    B.5.3.4CountrySpain
    B.5.6E-mailapitas@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 holderMerck Sharp Dohme Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNCORIFOLLITROPIN ALFA
    D.3.9.1CAS number 195962-23-3
    D.3.9.2Current sponsor codeOrg 36286
    D.3.9.4EV Substance CodeSUB01455MIG
    D.3.10 Strength
    D.3.10.1Concentration unit µg microgram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    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 No
    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
    Suboptimal response of ovarian stimulation
    Respuesta suboptima de la Estimulación ovárica
    E.1.1.1Medical condition in easily understood language
    Number of oocytes
    Número de ovocitos
    E.1.1.2Therapeutic area Body processes [G] - Reproductive physiologi cal processes [G08]
    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
    Study the difference in the number of oocytes obtained by performing ovarian stimulation in the follicular phase vs. Luteal phase in a population of patients with a suboptimal prior response.
    Estudiar la diferencia en el número de ovocitos obtenidos realizando la estimulación ovárica en fase folicular vs. fase lútea en una población de pacientes con respuesta previa subóptima.
    E.2.2Secondary objectives of the trial
    • To evaluate if there are differences between both groups in terms of duration of stimulation
    • To Study of the differences between both groups regarding the consumption of gonadotropins and the cost of treatment
    • To Evaluate if there are differences between both groups in the cancellation rate of the stimulation cycle
    • To Evaluate if there are differences between both groups regarding the metaphase stage oocyte rate II
    • To Evaluate if there are differences between both groups in the rate of survival in the thawing and rate of fertilization after microinjection.
    • Evaluar si hay diferencias entre ambos grupos en cuanto a duración de la estimulación
    • Estudio de las diferencias entre ambos grupos en cuanto al consumo de gonadotropinas y coste del tratamiento
    • Evaluar si hay diferencias entre ambos grupos en la tasa de cancelación del ciclo de estimulación
    • Evaluar si hay diferencias entre ambos grupos respecto a la tasa de ovocitos en estadio de metafase II
    • Evaluar si hay diferencias entre ambos grupos en la tasa de supervivencia en la descongelación y tasa de fertilización tras microinyección.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    338/5000
    1. Less than 10 oocytes in a conventional pre-controlled ovarian stimulation protocol
    2. Age <41 years
    3. BMI between 18 and 32 kg / m2
    4. Regular menstrual cycles between 21 and 35 days.
    5. Indication of in vitro fertilization
    6. Indication to start the stimulation with 150mcg of corifolitropin alfa
    7. Presence of both ovaries
    1. Menos de 10 ovocitos en un protocolo controlado previo de estimulación ovárica convencional
    2. Edad < 41 años
    3. IMC entre 18 y 32 kg/m2
    4. Ciclos menstruales regulares entre 21 y 35 días.
    5. Indicación de fertilización in vitro
    6. Indicación de iniciar la estimulación con 150mcg de corifolitropina alfa
    7. Presencia de ambos ovarios
    8. Capacidad para participar y cumplir con el protocolo del estudio
    9. Haber dado su consentimiento por escrito
    E.4Principal exclusion criteria
    1. Presence of follicles larger than 10 mm in the randomization visit
    2. Endometriosis III / IV
    3. Bologna criteria: patients with less than 4 oocytes in a previous ovarian stimulation and poor ovarian reserve parameters
    4. Concurrent participation in another study
    1. Presencia de folículos mayores de 10 mm en la visita de randomización
    2. Endometriosis III/IV
    3. Criterios Bologna: pacientes con menos de 4 ovocitos en una estimulación ovárica previa y parámetros de reserva ovárica pobre
    4. Participación concurrente en otro estudio
    E.5 End points
    E.5.1Primary end point(s)
    Number of cumulo oocyte complexes obtained
    Número de complejos cumulo ovocitos obtenidos
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of the menstrual cycle
    Al final del ciclo menstrual
    E.5.2Secondary end point(s)
    • Number of metaphase II stage oocytes obtained Duration of stimulation (days)
    • Cancellation fee
    • Fertilization rate
    • Dosage of medication used
    • Cost of oocyte treatment obtained
    • Número de ovocitos en estadio de metafase II obtenidos Duración de la estimulación (días)
    • Tasa de cancelación
    • Tasa de fertilización
    • Dosis de medicación utilizada
    • Coste del tratamiento por ovocito obtenido
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of the menstrual cycle
    Al final del ciclo menstrual
    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 No
    E.6.4Safety No
    E.6.5Efficacy No
    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 Yes
    E.6.13.1Other scope of the trial description
    The efficacy of the treatment administered at the usual time of clinical practice will be compared with the efficacy of administering it at another time.
    Se comparará la eficacia del tratamiento administrado en el momento habitual de la práctica clínica con la eficacia de administrarlo en otro momento
    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 Yes
    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 Yes
    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
    Administración en fase folicular (convencional) comparado con la administración en fase lútea
    Administration in follicular phase (conventional) compared to administration in luteal phase
    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
    LVSL
    LVSL
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months7
    E.8.9.1In the Member State concerned days
    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: 41
    F.1.3Elderly (>=65 years) No
    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 Yes
    F.3.3.1Women of childbearing potential not using contraception Yes
    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 state41
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 41
    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)
    None
    Ninguno
    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 Decision2019-08-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-06-26
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2022-04-02
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