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    Summary
    EudraCT Number:2014-005099-27
    Sponsor's Protocol Code Number:IIBSP-FOS-2014-67
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2015-03-27
    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 number2014-005099-27
    A.3Full title of the trial
    randomized, single blind, prospective clinical study to compare hFSH-HP (Fostipur) and hMG-HP (Menopur) in patients with polycystic ovary ander a FIV/ICSI cicle.
    Estudio clínico prospectivo, randomizado y de ciego simple comparando hFSH-HP (Fostipur) y hMG-HP (Menopur) en pacientes con ovario poliquístico y sometidas a un ciclo de FIV/ICSI.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    randomized, single blind, prospective clinical study to compare hFSH-HP (Fostipur) and hMG-HP (Menopur) in patients with polycystic ovary ander a FIV/ICSI cicle
    Estudio clínico prospectivo, randomizado y de ciego simple comparando hFSH-HP (Fostipur) y hMG-HP (Menopur) en pacientes con ovario poliquístico y sometidas a un ciclo de FIV/ICSI.
    A.4.1Sponsor's protocol code numberIIBSP-FOS-2014-67
    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 SponsorInstitut de Recerca de l?Hospital de la Santa Creu i Sant Pau ? IIB Sant Pau
    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 supportAngelini Farmacéutica.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitut de Recerca de l?Hospital de la Santa Creu i Sant Pau ? IIB Sant Pau
    B.5.2Functional name of contact pointUCICEC Coordinator
    B.5.3 Address:
    B.5.3.1Street AddressSant Antoni Mª Claret
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08025
    B.5.3.4CountrySpain
    B.5.4Telephone number+3493 553 78 69
    B.5.5Fax number+3493 553 78 12
    B.5.6E-mailcdelgadoe@santpau.cat
    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
    D.2.1.1.2Name of the Marketing Authorisation holderAlgelini Farmacéutica
    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 solution 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 INNUROFOLLITROPIN
    D.3.9.1CAS number 97048-13-0
    D.3.9.3Other descriptive nameUROFOLLITROPIN
    D.3.9.4EV Substance CodeSUB05053MIG
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number75 to 150
    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 Menopur
    D.2.1.1.2Name of the Marketing Authorisation holderFerring, S.A.U.
    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 solution 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 INNHUMAN CHORIONIC GONADOTROPIN
    D.3.9.3Other descriptive nameHUMAN CHORIONIC GONADOTROPIN
    D.3.9.4EV Substance CodeSUB01277MIG
    D.3.10 Strength
    D.3.10.1Concentration unit U unit(s)
    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.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
    women with polycystic ovary under a cicle of FIV/ICSI.
    Mujeres con ovarios poliquísticos que se someten a un tratamiento de FIV/ICSI.
    E.1.1.1Medical condition in easily understood language
    women with polycystic ovary under a cicle of FIV/ICSI.
    Mujeres con ovarios poliquísticos que se someten a un tratamiento de FIV/ICSI.
    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 evaluate efficacy meassure as quantity of mature oocytes respect to the total oocytes using hFSH-HP vs. hMG-HP in patients with polycystic under a FIV/ICSI cicle.
    El objetivo principal de este estudio es el de evaluar la efectividad medida como la cantidad de ovocitos maduros en MII respecto al total de ovocitos recuperados con el uso de un medicamento con FSH (hFSH-HP) comparado con un fármaco con FSH y LH (hMG-HP), en pacientes que presentan ovarios poliquísticos y sometidas a un ciclo de FIV/ICSI.
    E.2.2Secondary objectives of the trial
    To compare both products regarding
    stimulation days
    total dose
    number of follicles with 16 mm diameter
    number of follicles with 13-15 mm diameter
    number of ovocytes after OPU
    number and quality of embryo
    fertilization rate
    embryo implantantion rate
    gestation rate by started cicle/punction and transference
    rate of living newborn
    abort rate
    cancelation rate

    To evaluate safety
    Comparar si existen diferencias significativas entre ambos medicamentos, en relación a los siguientes parámetros:
    Días de estimulación
    Dosis total de gonadotropinas administrada
    Número de folículos de diámetro 16 mm
    Número de folículos de diámetro 13-15 mm
    Número de ovocitos recuperados el día de la OPU
    Número de embriones y calidad de los embriones
    Tasa de fertilización
    Tasa de implantación por embrión transferido
    Tasa de gestación por ciclo iniciado / por punción / por transferencia
    Tasa de recién nacido vivo
    Tasa de aborto
    Tasa de cancelación (ciclos que no llegan a punción)
    Tasa de cancelación y con criopreservación de embriones

    Evaluar la seguridad de hFSH-HP versus hMG-HP en pacientes con ovario poliquístico, y sometidas a un tratamiento FIV/ICSI, medido a través de la tasa de OHSS moderada/grave.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Female age between 18 and 38 years (inclusive)
    2. Women with a BMI under 30 kg / m2
    3. Diagnosis of PCOS or polycystic ovary syndrome (according to criteria of Rotterdam)
    4. Women who want pregnancy
    5. basal basal FSH levels under or equal 10 IU / l
    6. Infertility justify treatment with FIV / ICSI-ET
    7. To be included in a protocol with GnRH antagonist
    8. Presence of both ovaries and uterus able to support embryo implantation and pregnancy
    9. Absence of pregnancy before starting ovarian stimulation
    10. Having given written consent
    1. Edad de la mujer entre 18 años y 38 años (ambos inclusive)
    2. Mujeres con un IMC por debajo de 30 Kg/m2
    3. Diagnóstico de ovario poliquístico o de síndrome de ovario poliquístico (según criterios de Rotterdam)
    4. Mujer que desea el embarazo
    5. Niveles basales de FSH basal ? 10 UI/l
    6. Infertilidad que justifique el tratamiento con FIV/ICSI-TE
    7. Estar incluida en un protocolo con antagonista de la GnRH
    8. Presencia de ambos ovarios y útero capaz de soportar la implantación del embrión y el embarazo
    9. Ausencia de embarazo antes de iniciar la estimulación ovárica
    10. Haber dado su consentimiento por escrito
    E.4Principal exclusion criteria
    1. severe male factor not allowing an FIV / ICSI with ejaculated sample
    2. Patients with low ovarian reserve
    3. important endocrine-metabolic systemic diseases affecting pituitary, thyroid, adrenals, pancreas, liver or kidney
    4. HIV seropositivity
    5. to have frozen embryos from previous cycles of assisted reproduction
    6. undiagnosed vaginal haemorrhage
    7. Poor response in previous cycles of FIV with standard stimulation protocols
    8. Pregnancy, lactation or contraindication to get pregnant
    9. Malformations of the sexual organs incompatible with pregnancy
    10. History of allergy to gonadotrophin preparations or its excipients
    11. Alcohol, drugs or psychotropic addiction
    12. Concurrent participation in another study
    13. Previous history of severe hyperstimulation syndrome
    14. Concomitant medication that may interfere with the study medication: different hormonal treatments used in the study, other thyroid hormones, antipsychotics, anxiolytics, hypnotics, sedatives, chronic treatment with inhibitors of prostaglandin
    1. Factor masculino severo que no permita realizar una FIV/ICSI con muestra de eyaculado
    2. Pacientes con baja reserva ovárica
    3. Enfermedades sistémicas importantes, endócrino-metabólicas que afecten hipófisis, tiroides, suprarrenales, páncreas, hígado o riñón
    4. Seropositividad VIH
    5. Tener embriones congelados de ciclos anteriores de reproducción asistida
    6. Hemorragias vaginales no diagnosticada
    7. Malas respuesta en ciclos previos de FIV con protocolos de estimulación estándar
    8. Embarazo, lactancia o contraindicación para quedar embarazada
    9. Malformaciones de los órganos sexuales incompatibles con el embarazo
    10. Alergia conocida a los preparados de gonadotropinas o sus excipientes
    11. Dependencia actual de alcohol, drogas o psicofármacos
    12. Participación concurrente en otro estudio
    13. Historia previa de Síndrome de hiperestimulación grave
    14. Medicación concomitante que pueda interferir con la medicación en estudio: tratamientos hormonales distintos de los utilizados en el estudio, excepto hormonas tiroideas, antipsicóticos, ansiolíticos, hipnóticos, sedantes, tratamiento crónico con inhibidores de prostaglandinas
    E.5 End points
    E.5.1Primary end point(s)
    quantity of mature oocytes respect to the total oocytes
    Cantidad de ovocitos maduros comparado con ovocitos totales
    E.5.1.1Timepoint(s) of evaluation of this end point
    30 days
    30 dias
    E.5.2Secondary end point(s)
    stimulation days
    total dose
    number of follicles with 16 mm diameter
    number of follicles with 13-15 mm diameter
    number of ovocytes after OPU
    number and quality of embryo
    fertilization rate
    embryo implantantion rate
    gestation rate by started cicle/punction and transference
    rate of living newborn
    abort rate
    cancelation rate
    Días de estimulación
    Dosis total de gonadotropinas administrada
    Número de folículos de diámetro 16 mm
    Número de folículos de diámetro 13-15 mm
    Número de ovocitos recuperados el día de la OPU
    Número de embriones y calidad de los embriones
    Tasa de fertilización
    Tasa de implantación por embrión transferido
    Tasa de gestación por ciclo iniciado / por punción / por transferencia
    Tasa de recién nacido vivo
    Tasa de aborto
    Tasa de cancelación (ciclos que no llegan a punción)
    Tasa de cancelación y con criopreservación de embriones
    E.5.2.1Timepoint(s) of evaluation of this end point
    30 days
    30 days
    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 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
    Serios adverse event that under physician criteria is not indicated to continue treatment
    absence of ovaric response (less than 3 follicle with diametre higher or equal to 18 mm)
    Reacción adversa grave o que a juicio de los médicos no resulte compatible con la continuación de la exposición.
    Respuesta ovárica insuficiente, que se define como ausencia de al menos 3 folículos con diámetro mayor o igual a 18 mm
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months
    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: 164
    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 state164
    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)
    not applicable
    no aplica
    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 Decision2015-05-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-04-15
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2016-02-15
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