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    Summary
    EudraCT Number:2009-017854-11
    Sponsor's Protocol Code Number:FIBHGM-ECNC004-2010(FEBRES-09)
    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:2010-04-20
    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 number2009-017854-11
    A.3Full title of the trial
    Efecto de la dosis de FSH recombinante en el resultado de la estimulación ovárica para fecundación in vitro en pacientes con baja reserva ovárica. Estudio aleatorizado y abierto de no inferioridad.(Version 3.0 que incluye la MR01).
    A.4.1Sponsor's protocol code numberFIBHGM-ECNC004-2010(FEBRES-09)
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorFundación para la Investigación Biomédica del Hospital Gregorio Marañón
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisation
    B.5.2Functional name of contact point
    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 PUREGON 900 UI/1,08 ml solución inyectable
    D.2.1.1.2Name of the Marketing Authorisation holderORGANON, N.V.
    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 Information not present in EudraCT
    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 INNFOLITROPINA BETA
    D.3.9.3Other descriptive nameFOLLITROPIN BETA
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number900
    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) Information not present in EudraCT
    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 Information not present in EudraCT
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
    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 Information not present in EudraCT
    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 Yes
    D.3.11.13.1Other medicinal product typeMedicamento de origen recombinante
    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
    Hiperestimulación ovárica controlada para inducir el desarrollo de folículos múltiples en
    programas de reproducción asistida
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9
    E.1.2Level LLT
    E.1.2Classification code 10021572
    E.1.2Term In vitro fertilization
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 9
    E.1.2Level LLT
    E.1.2Classification code 10021926
    E.1.2Term Infertility
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Evaluar la no inferioridad del resultado de la estimulación del desarrollo folicular múltiple para fecundación in vitro en pacientes con dosis de 225 UI/día de FSHr respecto a dosis de 450 UI/día, en pacientes con reserva funcional ovárica disminuida, y en términos de número de ovocitos totales y maduros obtenidos, y de número de ovocitos fecundados, y considerando como límite de no inferioridad de la diferencia de medias dos ovocitos.
    E.2.2Secondary objectives of the trial
    Evaluar exploratoriamente la no inferioridad del porcentaje de gestación obtenido en el grupo de tratamiento con menor dosis respecto al grupo tratado con dosis más alta, y de otras variables de eficacia (número medio de embriones evolutivos totales y de alta calidad, de embriones transferidos y congelados, porcentaje de gestación por ciclo iniciado, por punción y por transferencia embrionaria, porcentaje de cancelación por baja respuesta, duración de la estimulación, dosis total de FSH, estradiol al final de la estimulación) y seguridad (porcentaje de gestación múltiple, porcentaje de cancelación por riesgo de síndrome de hiperestimulación ovárica, porcentaje de incidencia de síndrome de hiperestimulación ovárica, porcentaje de aborto, porcentaje de reacciones adversas).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    : Edad inferior a 40 años, diagnóstico de sospecha de baja reserva ovárica, establecido por la presencia de al menos uno de los siguientes criterios: a) nivel de FSH basal (tercer día del ciclo) igual o superior a 9 UI/L, b) recuento basal total de folículos antrales inferior a seis, inexistencia de antecedente de tratamiento previo con FIV, indicación de FIV o microinyección espermática, ausencia de contraindicaciones para el tratamiento con FIV o microinyección espermática, ausencia de contraindicaciones para el tratamiento con los fármacos incluidos en el protocolo y en los términos establecidos por éste, y consentimiento informado.
    E.4Principal exclusion criteria
    Edad superior a 40 años, antecedente de tratamiento previo con FIV, nivel de FSH basal (tercer día del ciclo) inferior a 10 UI/L, recuento basal total de folículos antrales igual o superior a seis, factor masculino extremo (Indicación de microinyección espermática con espermatozoides testiculares o epididimarios), contraindicaciones para el tratamiento con FIV o microinyección espermática, contraindicaciones para el tratamiento con los fármacos incluidos en el protocolo y en los términos establecidos por éste, y negativa a firmar el consentimiento informado.
    E.5 End points
    E.5.1Primary end point(s)
    Variables independientes (poblacionales): Edad, duración de la esterilidad, causas de la esterilidad, técnica de fecundación, día de transferencia, dificultad para la transferencia.
    Variables dependientes (de respuesta): Variables de eficacia: Principales: número de ovocitos totales y en metafase II, número de ovocitos fecundados (cigotos totales y bipronucleares). Secundarias: Duración de la estimulación ovárica, consumo de gonadotropinas, estradiol sérico en día de administración de HCGr, número folículos > 17 mm y > 15 mm, espesor endometrial en día de administración de HCGr, porcentaje de embriones evolutivos en segundo y tercer día de cultivo, número de embriones de calidad óptima y no óptima, número de embriones transferidos y criopreservados, porcentaje de implantación por ciclo iniciado y por ciclo con transferencia, positividad de la prueba bioquímica de gestación, número de sacos gestacionales, y porcentaje de cancelación por respuesta insuficiente. Variables de seguridad y tolerabilidad: Porcentaje de gestación múltiple, porcentaje de cancelación por riesgo de síndrome de hiperestimulación ovárica, porcentaje de incidencia de síndrome de hiperestimulación ovárica, porcentaje de aborto, porcentaje de reacciones adversas locales.
    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 Yes
    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 Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    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) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Medicamento de investigación a distinta dosis
    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 Information not present in EudraCT
    E.8.7Trial has a data monitoring committee Yes
    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
    Final del periodo de observación del último sujeto incluido, en los términos establecidos en el protocolo.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    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 state108
    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 Decision2010-06-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2010-05-16
    P. End of Trial
    P.End of Trial StatusOngoing
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