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    Summary
    EudraCT Number:2013-002482-19
    Sponsor's Protocol Code Number:13EU/FSH01
    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:2013-11-25
    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 number2013-002482-19
    A.3Full title of the trial
    Randomised clinical trial comparing highly purified FSH formulation (Fostimon®) and recombinant FSH (Gonal-F®) in GnRH-antagonist controlled ovarian hyperstimulation cycles.
    Ensayo clínico aleatorizado para comparar una formulación de FSH altamente purificada (Fostimon®) con una FSH recombinante (Gonal F®) en ciclos de hiperestimulación ovárica controlada con antagonistas de la GnRH
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A comparison of two types of follicle stimulating hormone (FSH) formulations during fertility treatment.
    Comparación de dos tipos de formulaciones de hormonas foliculostimulantes (FSH) durante el tratamiento de fertilidad
    A.3.2Name or abbreviated title of the trial where available
    IBSA Study 13EU/FSH01
    Estudio IBSA 13EU/FSH01
    A.4.1Sponsor's protocol code number13EU/FSH01
    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 SponsorIBSA Institut Biochimique S.A.
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportIBSA Institut Biochimique S.A.
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationLB Research srl
    B.5.2Functional name of contact pointClinical Operations Department
    B.5.3 Address:
    B.5.3.1Street AddressVia Lombardia, 81
    B.5.3.2Town/ cityCantù
    B.5.3.3Post code22063
    B.5.3.4CountryItaly
    B.5.4Telephone number0039031734908
    B.5.5Fax number00390317372218
    B.5.6E-maillaura.rinaldi@lbresearch.it
    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 kit 75 UI
    D.2.1.1.2Name of the Marketing Authorisation holderAngelini Spain
    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 nameFostipur
    D.3.4Pharmaceutical form Powder and solvent for solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    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 Yes
    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 Gonal-F
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Serono
    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 nameGonal-F
    D.3.4Pharmaceutical form Powder and solvent for solution for injection in pre-filled syringe
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    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.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
    female infertility
    INFERTILIDAD FEMENINA
    E.1.1.1Medical condition in easily understood language
    women submitted to assisted reproductive technology (ART) requiring ovaries stimulation
    Mujeres sometidas a técnicas de reproducción asistida que requieren estimulación ovárica
    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 14.1
    E.1.2Level LLT
    E.1.2Classification code 10016398
    E.1.2Term Female infertility
    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
    The purpose of the non-inferiority study is to evaluate the clinical efficacy and the safety of two different subcutaneous FSH preparations (Fostimon®, IBSA Institut Biochimique SA versus Gonal-F®) for controlled ovarian hyperstimulation in a GnRH-antagonist cycle
    El objetivo de este estudio de no inferioridad es determinar la eficacia clínica y la seguridad de dos preparados distintos de FSH para administración subcutánea (Fostimon® y Gonal-F®) en la hiperestimulación ovárica con antagonistas de la GnRH.
    E.2.2Secondary objectives of the trial
    1) Ovarian stimulation
    2) Oocyte quality
    3) Embryo quality
    4) Final result
    1) Estimulación ovárica
    2) Calidad del oocito
    3) Calidad del embrion
    4) Resultado final
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    -Able and willing to sign the Patient Consent Form and adhere to the study visitation schedule;
    -> =18 and <39 years old;
    -BMI: > =18 and < =28 kg/m2;
    -Less than 3 previously completed IVF cycles (i.e. completed cycle = egg recovery);
    -Basal FSH <10 IU/L and E2 <80 pg/ml (~290 pmol/l);
    -TSH < 2.5 mIU/L
    ->10 antral follicles 2-10 mm in size for both ovaries combined (measured day 2-4 of menstrual cycle)
    -AMH > 1 ng/ml (7.15 pmol/l) and < 4 ng/ml (28.6 pmol/l)
    -Presence and adequate visualisation of both ovaries;
    -Within 12 months of the beginning of the study, uterine cavity consistent with expected normal function as assessed through transvaginal ultrasound, hysterosalpingogram, sonohysterogram or hysteroscopic examination.
    Podrán participar mujeres sometidas a estimulación ovárica para la FIV que presenten las características siguientes:
    - capacidad y voluntad de firmar el documento de consentimiento informado y de ceñirse al calendario de visitas;
    - edad >= 18 y < 39 años;
    - IMC >= 18 y <= 28 kg/m2;
    - haberse sometido a menos de 3 ciclos de FIV completos (es decir, con punción ovárica);
    - niveles basales de FSH < 10 UI/l y E2 < 80 pg/ml (~290 pmol/l);
    - TSH < 2,5 mUI/l;
    - > 10 folículos antrales de 2-10 mm contando ambos ovarios (determinación entre los días 2.º y 4.º del ciclo menstrual);
    - AMH > 1 ng/ml (7,15 pmol/l) y < 4 ng/ml (28,6 pmol/l);
    - presencia y visualización satisfactoria de ambos ovarios;
    - cavidad uterina compatible con la función normal según un estudio por ecografía transvaginal, histerosalpingografía, histeroecografía o histeroscopia en los 12 meses previos al inicio del ensayo.
    E.4Principal exclusion criteria
    -Age <18 and > =39 years;
    -Primary ovarian failure or women known as poor responders (according to the Bologna criteria1);
    -PCO & PCOS (according to Rotterdam criteria2);
    -Severe OHSS in a previous COH cycle;
    -Uterine malformation that may impair the possibility to get pregnant;
    -Ovarian cysts >10 mm;
    -Hydrosalpinx that have not been surgically removed or ligated;
    -Endometriosis stage 3 or 4;
    -Oocyte donation;
    -Severe male factor
    -Patients affected by pathologies associated with any contraindication of being pregnant;
    -History of recurrent miscarriage (i.e. more than 3 previous miscarriages);
    -Hypersensitivity to the study medication;
    -Abnormal bleeding of undetermined origin;
    -Uncontrolled thyroid or adrenal dysfunction;
    -Neoplasias;
    -Severe impairment of renal and/or hepatic function;
    -use of concomitant medications that might interfere with study evaluations (e.g. non-study hormonal medications, prostaglandin inhibitors, psychotropic agents).
    - Edad < 18 ó >= 39 años;
    - insuficiencia ovárica primaria o mala respuesta documentada
    (según los criterios de Bolonia1);
    - poliquistosis ovárica o síndrome del ovario poliquístico
    (según los criterios de Rotterdam2);
    - antecedentes de SHO severo en un ciclo anterior de hiperestimulación;
    - malformación uterina que menoscabe la posibilidad de concebir;
    - quistes ováricos > 10 mm;
    - hidrosalpinge sin ligar ni eliminar quirúrgicamente;
    - endometriosis en estadio 3 ó 4;
    - donación de ovocitos;
    - esterilidad masculina importante;
    - patologías asociadas con contraindicaciones del embarazo;
    - antecedentes de abortos de repetición (más de 3 abortos);
    - hipersensibilidad a los fármacos en estudio;
    - hemorragias de origen incierto;
    - disfunción tiroidea o suprarrenal sin controlar;
    - neoplasias;
    - afectación grave de la función renal o hepática;
    - administración simultánea de medicamentos que vayan a interferir con las evaluaciones del ensayo (p. ej., otros medicamentos hormonales, inhibidores de la prostaglandina, psicofármacos, etc.).
    E.5 End points
    E.5.1Primary end point(s)
    Clinical pregnancy rate, per stimulated cycle, per oocyte retrieval and per embryo transfer. A clinical pregnancy is defined as a pregnancy showing ultrasound embryonic heart activity at 8 weeks of gestation.
    Tasa de embarazos clínicos, por ciclo de estimulación, por recuperación de ovocitos y por transferencia de embriones. Por embarazo clínico se entiende aquél en el cual se observa mediante ecografía la actividad cardíaca del embrión a la 8.ª semana de gestación.
    E.5.1.1Timepoint(s) of evaluation of this end point
    week 8 of pregnancy
    semana 8 de embarazo
    E.5.2Secondary end point(s)
    1) Ovarian stimulation
    ? Mean FSH dose (daily and total);
    ? Number of days of FSH stimulation;
    ? Number of follicles >16 mm on the day of hCG injection;
    ? Progesterone and 17 beta-estradiol levels on the day of hCG triggering;
    ? Cancellation rate with reasons.
    2) Oocyte quality
    ? Total number of oocytes retrieved;
    ? Mean number of mature oocytes (grade III-metaphase II) and ratio MII/Total oocytes retrieved;
    ? Mean number of immature oocytes and ration Immature/total oocytes retrieved;
    ? Mean number inseminated/injected oocytes;
    ? Fertilization rate: defined as the number of 2PN (or already cleaved) embryos on Day 1 divided by the total number of injected/ inseminated oocytes;
    ? Cleavage rate: defined as the number of cleaved embryos on culture day 2 divided by the total number of injected/inseminated oocytes.
    3) Embryo quality
    ? Total number of embryos obtained, plus number transferred and frozen;
    ? Embryo quality: assessment of blastomeres number and embryo morphology parameters: degree of fragmentation and cell division aspect.
    4) Final result
    ? Positive beta-hCG test per oocyte retrieval and per embryo transfer;
    ? Implantation rate, defined as the ratio of the number of implanted embryos (presence of gestational sac assessed by ultrasound) and the number of transferred embryos.
    Estimulación ovárica
    ? Dosis media de FSH (diaria y total).
    ? Número de días de estimulación con FSH.
    ? Número de folículos > 16 mm el día de la inyección de hCG.
    ? Niveles de progesterona y 17?-estradiol el día de la inducción con hCG.
    ? Tasa de cancelaciones y motivos.

    Calidad de los ovocitos
    ? Número total de ovocitos obtenidos.
    ? Número medio de ovocitos maduros (grado III, metafase II) y proporción de ovocitos en metafase II sobre el total obtenido.
    ? Número medio de ovocitos inmaduros y proporción de inmaduros sobre el total obtenido.
    ? Número de ovocitos obtenidos por unidades del fármaco administradas.
    ? Número medio de ovocitos inseminados/inyectados.
    ? Tasa de fecundación.
    ? Tasa de segmentación.

    Calidad de los embriones
    ? Número total de embriones obtenidos, más número de embriones transferidos y congelados.
    ? Calidad de los embriones.

    Resultado final
    ? Positivos en la prueba de la ?-hCG por recuperación de ovocitos y por transferencia de embriones.
    ? Tasa de implantación, definida como la proporción de embriones implantados (observación de saco gestacional en la ecografía) sobre el número de transferidos.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Ovarian stimulation: Visit 4 (induction of ovulation)
    Oocite quality: Visit 5 (oocyte collection) and V6 (embryo transfer)
    Embryo quality: Visit 6 (embryo transfer)
    Final result: visit 7 (pregnancy test) and Visit 8 (pregnancy confirmation and TVUS)
    Estimulación ovárica: visita 4 (inducción de la ovulación)
    Calidad del oocito: Visita 5 ( recogida de los oocitos) y visita 6 (transferencia de embriones)
    Calidad del embrión: visita 6 (transferencia de embriones).
    Resultado final: Visita 7 (test de embarazo) y Visita 8 (confirmación de la gestación mediante ecografia transvaginal)
    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 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 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 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 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 concerned4
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA12
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    Italy
    Spain
    Switzerland
    Turkey
    United Kingdom
    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 último sujeto
    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
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days0
    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: 720
    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 state160
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 480
    F.4.2.2In the whole clinical trial 720
    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
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2014-01-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2013-12-17
    P. End of Trial
    P.End of Trial StatusCompleted
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