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    The EU Clinical Trials Register currently displays   43876   clinical trials with a EudraCT protocol, of which   7294   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2017-002341-30
    Sponsor's Protocol Code Number:1705-VLC-030-JG
    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:2017-06-27
    Trial results View 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 number2017-002341-30
    A.3Full title of the trial
    Usefulness of medroxyprogesterone acetate in the follicular phase for ovarian donors to prevent premature luteinization
    Utilidad del acetato de medroxiprogesterona en fase folicular en donantes de óvulos para la prevención de la luteinización precoz
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Usefulness of medroxyprogesterone acetate in the follicular phase for ovarian donors which are undergoing controlled ovarian stimulation (COS)
    Utilidad del acetato de medroxiprogesterona en fase folicular en donantes de óvulos sometidas a estimulación ovárica
    A.3.2Name or abbreviated title of the trial where available
    Prevent premature luteinization
    Prevención de luteinización precoz
    A.4.1Sponsor's protocol code number1705-VLC-030-JG
    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 VALENCIANO DE INFERTILIDAD (IVI)
    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 VALENCIANO DE INFERTILIDAD (IVI)
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationINSTITUTO VALENCIANO DE INFERTILIDAD (IVI)
    B.5.2Functional name of contact pointJuan Giles
    B.5.3 Address:
    B.5.3.1Street AddressPlaza Polícia Local,3
    B.5.3.2Town/ cityValencia
    B.5.3.3Post code46015
    B.5.3.4CountrySpain
    B.5.4Telephone number+34963050900
    B.5.5Fax number+34963050999
    B.5.6E-mailjuan.giles@ivi.es
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleComparator
    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 ORGALUTRAN
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Sharp & Dohme Limited
    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 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 INNGANIRELIX
    D.3.9.3Other descriptive nameGANIRELIX
    D.3.9.4EV Substance CodeSUB07883MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.25
    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.IMP: 2
    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 PROGEVERA
    D.2.1.1.2Name of the Marketing Authorisation holderPFIZER, S.L
    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 Tablet
    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 INNMEDROXYPROGESTERONE ACETATE
    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
    prevent premature luteinitation
    evitar luteinización precoz
    E.1.1.1Medical condition in easily understood language
    premature luteinization
    evitar luteinización precoz
    E.1.1.2Therapeutic area Body processes [G] - Reproductive physiologi cal processes [G08]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10072070
    E.1.2Term Oocyte donor
    E.1.2System Organ Class 10041244 - Social circumstances
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To compare the number of oocytes and metaphase II oocytes (MII) from donors that have received ovarian stimulation with FSHr and in which it has been used to an antagonist of GnRH vs AMP for prevent early luteinization.
    Comparar el número de ovocitos y ovocitos metafase II (MII) procedentes de donantes que han recibido estimulación ovárica con FSHr y en las que se ha empleado para evitar luteinización precoz antagonista de la GnRH vs AMP.
    E.2.2Secondary objectives of the trial
    To compare Clinical results in donor:
    • Incidence of early luteinization.
    • OHSS (Ovarian hyperstimulation syndrome) incidence.
    • Days of stimulation and dose of gonadotropins administered
    • Comparison of side effects between both protocols in donors
    • Analysis of serum hormone profile: estradiol, progesterone and LH
    - Cost of each protocol
    - Convenient employment for donors (Evaluate the degree of satisfaction of donors according to the protocol used)
    Comparar los resultados clínicos en donantes:
    • Incidencia de luteinización precoz.
    • Incidencia SHO.
    • Días de estimulación y dosis de gonadotropinas administrada
    • Comparación efectos secundarios entre ambos protocolos en donantes
    • Análisis del perfil hormonal sérico: estradiol, progesterona y LH
    - Coste de cada protocolo
    - Comodidad de empleo para las donantes (Evaluar el grado de satisfacción de las donantes en función del protocolo utilizado)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Female subjects between 18-35 years old
    - No personal or family history of interest
    - Sign Informed Consent
    - From the medical point of view:
    Body mass index between 18-28 kg / m2
    Uterus and normal ovaries, without organic pathology
    Non-polycystic ovaries
    Count of antral follicles> 12 in the sum of the two ovaries
    Normal karyotype
    Negative screening for infectious diseases (Hepatitis B Virus, Hepatitis C Virus, Human Immunodeficiency Virus and Syphilis)
    General Analytic with hemogram, hemostasis and biochemistry with parameters within normality.
    - Mujer entre 18-35 años de edad
    - Sin antecedentes personales ni familiares de interés
    - Que firmen el Consentimiento Informado
    - Desde el punto de vista médico:
    o Índice de masa corporal entre 18-28 kg/m2
    o Útero y ovarios normales, sin patología orgánica
    o No ovarios de aspecto poliquístico
    o Recuento de folículos antrales superior a 12 en la suma de los dos ovarios
    o Cariotipo normal
    o Negativo el screening de enfermedades infecciosas (Virus Hepatitis B, Virus Hepatitis C, Virus de Inmunodeficiencia Humana y Sífilis)
    o Analítica general con hemograma, hemostasia y bioquímica con parámetros dentro de la normalidad.
    E.4Principal exclusion criteria
    - Simultaneous participation in another clinical study
    - Participation in another clinical study 2 months before inclusion in the present study that could affect the objectives of the study
    - Any systemic or metabolic disorder that contraindicates the use of gonadotrophins.
    - History of thrombophlebitis and thromboembolic phenomena and HT
    - Known hypersensitivity to AMP or its excipients
    - Any motive that implies exclusion from the oocyte donation program
    - Suspect or evidence of mammary malignancy or hormone-dependent genitalia
    - Known infection with human immunodeficiency virus, active virus of hepatitis B or C.
    - Participación simultánea en otro estudio clínico
    - Participación en otro estudio clínico 2 meses antes de la inclusión en el presente estudio que pudiera afectar a los objetivos del mismo
    - Cualquier trastorno sistémico o metabólico que contraindique el uso de gonadotrofinas.
    - Antecedentes de tromboflebitis y fenómenos tromboembólicos e HTA
    - Hipersensibilidad conocida al AMP o sus excipientes
    - Cualquier motivo que implique exclusión del programa de donación de ovocitos
    - Sospecha o evidencia de malignidad mamaria o de los órganos genitales hormono -dependientes
    - Infección conocida con virus de inmunodeficiencia humana, virus activo de la hepatitis B o C.
    E.5 End points
    E.5.1Primary end point(s)
    Number of oocytes Metaphase II and mature oocyte rate
    Número de ovocitos Metafase II y tasa de ovocito maduro
    E.5.1.1Timepoint(s) of evaluation of this end point
    Before embryo-transfer
    Antes del transfer de embriones
    E.5.2Secondary end point(s)
    • Incidence of early luteinization
    • SHO incidence
    • Area under the curve of serum estradiol during ovarian stimulation
    • Area under the serum progesterone curve during ovarian stimulation
    • Area under the serum LH curve during ovarian stimulation
    • Concentration of P4 in follicular fluid
    • Estradiol concentration in follicular fluid
    Concentration of FSH in follicular fluid
    • Concentration of LH in follicular fluid
    • Cost of each protocol
    • Convenience of employment for donors
    • Incidencia de luteinización precoz
    • Incidencia SHO
    • Area bajo la curva de Estradiol sérico durante la estimulación ovárica
    • Area bajo la curva de progesterona sérica durante la estimulación ovárica
    • Area bajo la curva de LH sérica durante la estimulación ovárica
    • Concentración de P4 en líquido folicular
    • Concentración de Estradiol en líquido folicular
    • Concentración de FSH en líquido folicular
    • Concentración de LH en líquido folicular
    • Coste de cada protocolo
    • Comodidad de empleo para las donantes
    E.5.2.1Timepoint(s) of evaluation of this end point
    During the ovarian stimulation
    Durante la estimulación ovárica
    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 Yes
    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 Yes
    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) Yes
    E.7.4Therapeutic use (Phase IV) No
    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 Yes
    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) Yes
    E.8.2.2Placebo No
    E.8.2.3Other No
    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
    LVLS
    ULTIMA VISITA 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 months14
    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: 318
    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 state318
    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 Decision2017-09-11
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-09-05
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2019-06-25
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