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    Summary
    EudraCT Number:2022-002678-10
    Sponsor's Protocol Code Number:GF22002
    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:2023-01-16
    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 number2022-002678-10
    A.3Full title of the trial
    Protocol with progestin-primed ovarian stimulation (PPOS) starting on day 5 versus protocol with progestin-primed ovarian stimulation (PPOS) in a conventional regimen from the start of the ovarian stimulation in oocyte donors.
    Protocolo con Progestin-primed Ovarian Stimulation (PPOS) en pauta fija en día 5 de estimulación versus Protocolo con Progestin-primed Ovarian Stimulation (PPOS) en pauta convencional desde inicio de estimulación en donantes de óvulos.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Comparison of two ovarian stimulation protocols in egg donors with one progestin as an ovulation inhibitor, one using the progestin starting on day 5 of the ovarian stimulation and the other one starting since the beginin of the ovarian stimulation.
    Comparación de dos protocolos de estimulación ovárica en donantes de óvulos con un progestágeno como inhibidor de la ovulación, uno con progestágeno a partir del día 5 de la estimulación ovárica y otro desde el inicio de la estimulación ovárica.
    A.3.2Name or abbreviated title of the trial where available
    PPOS start on day 5 versus conventional PPOS for the ovarian stimulation in oocyte donors.
    PPOS de inicio en día 5 versus PPOS convencional para estimulación ovárica en donantes de ovocitos
    A.4.1Sponsor's protocol code numberGF22002
    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 SponsorGinefiv
    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 supportGinefiv
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGinefiv
    B.5.2Functional name of contact pointInformación de ensayos clínicos
    B.5.3 Address:
    B.5.3.1Street AddressJose Silva 18
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28043
    B.5.3.4CountrySpain
    B.5.4Telephone number+34900908988
    B.5.6E-mailresearch@ginefiv.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.2.1.2Country 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.3.1Product nameacetato de medroxiprogesterona
    D.3.4Pharmaceutical form Pastille
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNmedroxiprogesterona
    D.3.9.2Current sponsor codemedroxiprogesterona
    D.3.9.3Other descriptive nameMedroxyprogesterone acetate
    D.3.9.4EV Substance CodeSUB03114MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    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
    Number of MII oocytes obtained in both groups
    Numero de ovocitos en MII obtenidos en ambos grupos
    E.1.1.1Medical condition in easily understood language
    Number of mature eggs obtained after the ovarian stimulation and egg retrieval in both grups of egg donors
    Número de óvulos maduros obtenidos tras la estimulación ovárica y extracción de óvulos en ambos grupos de donantes 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
    To study whether there is a difference in the number of MII oocytes obtained in both groups. The control group using progestin since the start of ovarian stimulation comparing it with the study group using progestin since day 5 of the ovarian stimulation in cycles of oocyte donors.
    Estudiar si existe diferencia en el número de ovocitos MII obtenidos en ambos grupos. El grupo control usando progestina desde el inicio de la estimulación ovárica comparándolo con el grupo de estudio usando progestina desde el día 5 de la estimulación ovárica en ciclos de donantes de ovocitos.
    E.2.2Secondary objectives of the trial
    • Assess whether there are differences between the two groups in terms of the duration of stimulation
    • Study of the differences between both groups regarding the consumption of total gonadotropins.
    • Assess whether there are differences between both groups in the rate of survival after egg thawing and in the rate of fertilization after microinjection.
    • Assess whether there are differences between both groups in terms of Lh levels on the day of triggering.
    • Assess if there are differences between both groups in terms of cancellation rate
    • Assess if there are differences between both groups regarding the rate of triggering failure
    •Evaluar si hay diferencias entre ambos grupos en cuanto a la duración de la estimulación
    •Estudio de las diferencias entre ambos grupos en cuanto al consumo de gonadotropinas totales.
    •Evaluar si hay diferencias entre ambos grupos en la tasa de supervivencia en la descongelación y en la tasa de fertilización tras microinyección.
    •Evaluar si hay diferencias entre ambos grupos en cuanto a los niveles de Lh en el día del triggering
    •Evaluar si hay diferencias entre ambos grupos en cuanto a la tasa de cancelación
    •Evaluar si hay diferencias entre ambos grupos en cuanto a la tasa de fallo de triggering (punción blanca)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Age between 18-35 years
    BMI between 18 and 32 kg/m2
    Ability to participate and adequately comply with the study protocol
    Signed medical consent form.
    Edad entre 18-35 años
    IMC entre 18 y 32 kg/m2
    Capacidad para participar y cumplir con el protocolo del estudio
    Haber dado su consentimiento por escrito
    E.4Principal exclusion criteria
    Donors with total antral follicle count of less than 10 (between both ovaries).
    Concurrent participation in another study.
    Donantes con recuento de folículos antrales menor a 10 entre ambos ovarios .
    Participación concurrente en otro estudio.
    E.5 End points
    E.5.1Primary end point(s)
    The number of MII oocytes obtained in both groups.
    El número de ovocitos MII obtenido en ambos grupos.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The day of the egg retrieval
    El día de la punción ovárica
    E.5.2Secondary end point(s)
    Total stimulation days
    Total dose of medication used
    Oocyte fertilization rate
    Cancellation rate
    Días de estimulación totales
    Dosis de medicacion utilizada en total
    Tasa de fertilizacion ovocitaria
    Tasa de cancelación
    E.5.2.1Timepoint(s) of evaluation of this end point
    The day after the egg retrieval
    El día despues de la punción ovarica
    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 Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response Yes
    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 No
    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 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 No
    E.8.2.4Number of treatment arms in the trial128
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    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
    LVLS
    La ultima visita medica del ultimo paciente
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months6
    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: 128
    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 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 state128
    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 Decision2023-03-07
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-08-02
    P. End of Trial
    P.End of Trial StatusOngoing
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