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    Summary
    EudraCT Number:2015-003779-31
    Sponsor's Protocol Code Number:BER-FSH-2015-01
    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:2015-10-30
    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 number2015-003779-31
    A.3Full title of the trial
    Prospective, Randomized Open Trial to Evaluate the Efficacy of Highly Purified Urinary FSH (Fostipur®, IBSA) versus Recombinant FSH (Bemfola® Finox) in Oocyte Donors Undergoing Controlled Ovarian Stimulation Based on Receptor N680S FSH Gene Polymorphism
    Estudio Prospectivo y Randomizado para Evaluar la Eficiencia de la FSH Recombinante (Bemfola® Finox) Comparada con la FSH de Origen Urinario (Fostipur®, IBSA) en Donantes de Ovocitos que Realizan una Estimulación Ovarica Controlada en Funcion del Polimorfismo N680S en el Gen del Receptor de la FSH
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Prospective, Randomized Open Trial to Evaluate the Efficacy of Highly Purified Urinary FSH (Fostipur®, IBSA) versus Recombinant FSH (Bemfola® Finox) in Oocyte Donors Undergoing Controlled Ovarian Stimulation Based on Receptor N680S FSH Gene Polymorphism
    Estudio Prospectivo y Randomizado para Evaluar la Eficiencia de la FSH Recombinante (Bemfola® Finox) Comparada con la FSH de Origen Urinario (Fostipur®, IBSA) en Donantes de Ovocitos que Realizan una Estimulación Ovarica Controlada en Funcion del Polimorfismo N680S en el Gen del Receptor de la FSH
    A.3.2Name or abbreviated title of the trial where available
    Genodon Trial
    Estudio Genodon
    A.4.1Sponsor's protocol code numberBER-FSH-2015-01
    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 organisationCROSSDATA
    B.5.2Functional name of contact pointMONTSE VIDAL
    B.5.3 Address:
    B.5.3.1Street AddressENRIC GRANADOS, 145
    B.5.3.2Town/ cityBARCELONA
    B.5.3.3Post code08008
    B.5.3.4CountrySpain
    B.5.4Telephone number0034663825890
    B.5.5Fax number0034931930364
    B.5.6E-mailmontsevidal@crossdata.es
    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 Fostipur 75 UI, polvo y disolvente para solución inyectable
    D.2.1.1.2Name of the Marketing Authorisation holderAngelini Farmacéutica, S.A.
    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 Powder and solvent for solution for 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 INNFOLLICLE-STIMULATING HORMONE
    D.3.9.1CAS number 9002-68-0
    D.3.9.3Other descriptive nameFOLLICLE-STIMULATING HORMONE
    D.3.9.4EV Substance CodeSUB25237
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number75
    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.IMP: 2
    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 Bemfola 225 UI/0,375 ml solución inyectable en pluma precargada
    D.2.1.1.2Name of the Marketing Authorisation holderFINOX Biotech AG
    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 in pre-filled pen
    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 INNFollitropin alfa
    D.3.9.2Current sponsor codeG03GA05
    D.3.9.3Other descriptive nameRECOMBINANT HUMAN FOLLICLE STIMULATING HORMONE
    D.3.9.4EV Substance CodeSUB20677
    D.3.10 Strength
    D.3.10.1Concentration unit IU international unit(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number225
    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.IMP: 3
    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 Fostipur 150 UI, polvo y disolvente para solución inyectable
    D.2.1.1.2Name of the Marketing Authorisation holderAngelini Farmacéutica, S.A.
    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 Powder and solvent for solution for 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 INNFOLLICLE-STIMULATING HORMONE
    D.3.9.1CAS number 9002-68-0
    D.3.9.3Other descriptive nameFOLLICLE-STIMULATING HORMONE
    D.3.9.4EV Substance CodeSUB25237
    D.3.10 Strength
    D.3.10.1Concentration unit IU/ml international unit(s)/millilitre
    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
    Ovarian stimulation for oocyte donation.
    Estimulación ovárica para donación de ovocitos
    E.1.1.1Medical condition in easily understood language
    Ovarian stimulation for oocyte donation.
    Estimulación ovárica para donación de ovocitos
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.1
    E.1.2Level LLT
    E.1.2Classification code 10021940
    E.1.2Term Infertility, female, of unspecified origin
    E.1.2System Organ Class 100000004872
    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 whether the effective use of urinary or recombinant FSH can be influenced by genotype of receptor N680S FSH Gene Polymorphism
    Estudiar si la eficacia en la utilización de FSH recombinante o Urinaria puede verse influenciada por el genotipo del polimorfismo N680S del gen del receptor de la FSH
    E.2.2Secondary objectives of the trial
    Study the differences in stimulation intensity using recombinant and urinary FSH.
    Study treatment cost by genotype FSH receptor and gonadotropin used (urinary versus recombinant)
    Study cost by oocyte obtained by genotype FSH receptor and gonadotropin used (urinary versus recombinant)
    Estudiar la diferencias en la intensidad de la estimulación con el uso de FSH recombinante y urinaria.
    Estudio de coste por tratamiento en función del genotipo del receptor de la FSH y de la gonadotropina utilizada (urinaria versus recombinante)
    Estudio de coste por ovocito obtenido en función del genotipo del receptor de la FSH y de la gonadotropina utilizada (urinaria versus recombinante)
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Be considered apt to get into the oocyte donation program of Instituto Bernabeu
    Age between 18 and 30 years
    Body Mass Index over 18 and under 28
    Antral follicle count greater than 9 and less than 25 (adding both ovaries)
    Patients starting ovarian stimulation with 225 IU of FSH
    Presence of both ovaries
    Ability to participate and comply with the study protocol
    Signing the written consent form
    Ser considerada apta para entrar en el programa de donación de ovocitos del Instituto Bernabeu
    Edad entre 18 y 30 años
    Indice de Masa Corproal mayor de 18 y menor de 28
    Recuento de folículos antrales mayor de 9 y menor de 25 (sumando ambos ovarios)
    Pacientes que inicien estimulación ovárica con 225 UI de FSH
    Presencia de ambos ovarios
    Capacidad para participar y cumplir con el protocolo del estudio
    Haber dado su consentimiento por escrito
    E.4Principal exclusion criteria
    Not suitable for inclusion in the oocyte donation program of Institute Bernabeu.
    Concurrent participation in another study
    No apta para ser incluida en el programa de donación de ovocitos del instituto Bernabeu.
    Participación concurrente en otro estudio
    E.5 End points
    E.5.1Primary end point(s)
    Number of cumulus-oocyte complexes obtained
    Numero de complejos cumulo-ovocito (CCO) obtenidos
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of ovarian stimulation, post-puncture
    Final de la estimulación ovárica, post-punción
    E.5.2Secondary end point(s)
    Number of metaphase II (MII) oocytes
    Number of useful oocytes (inseminated or microinjected)
    Duration of stimulation (days)
    FSH units obtained by oocyte
    FSH cost by oocyte obtained
    Fertilization rate
    Numero de ovocitos en estadio MII
    Numero de ovocitos útiles (inseminados o microinyectados)
    Duración de la estimulación (días)
    Unidades de FSH por ovocito obtenido
    Coste en FSH por ovocito obtenido
    Tasa de fertilización
    E.5.2.1Timepoint(s) of evaluation of this end point
    All (except the fertilization rate) at the end of ovarian stimulation, post-puncture
    Fertilization rate at 18 hours post-insemination
    Todos (excepto la tasa de fertilización) al final de la estimulación ovárica, post-punción
    Tasa de fertilización a las 18 horas post-inseminación
    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 Yes
    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) 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 No
    E.8.1.3Single blind Yes
    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) 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
    Última visita del último sujeto
    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: 180
    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 state180
    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)
    No treatment
    Ningún tratamiento
    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 Decision2015-12-04
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-09-30
    P. End of Trial
    P.End of Trial StatusOngoing
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