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    Summary
    EudraCT Number:2016-004114-99
    Sponsor's Protocol Code Number:FERTIRES-2016
    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:2016-12-27
    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 number2016-004114-99
    A.3Full title of the trial
    USE OF P.N680S POLYMORPHISM TO CHOOSE THE EXOGEN FSH DOSE IN CONTROLLED OVARIAN HYPERSTIMULATION: A PROSPECTIVE TRIAL
    USO DEL POLIMORFISMO p. N680S PARA ELEGIR LA DOSIS DE FSH EXÓGENA EN LA ESTIMULACIÓN OVÁRICA CONTROLADA: UN ENSAYO PROSPECTIVO
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    USE OF A GENETIC TEST RESULTS IN ORDER TO HELP PHYSICIANS TO CHOOSE THE DOSE OF EXOGEN FSH IN CONTROLLED OVARIAN HYPESTIMULATION
    USO DE LOS RESULTADOS DE UN TEST GENÉTICO PARA AYUDAR AL FACULTATIVO A ESCOGER LAS DOSIS DE FSH EXÓGENA EN LA ESTIMULACIÓN OVÁRICA CONTROLADA
    A.4.1Sponsor's protocol code numberFERTIRES-2016
    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 SponsorAB-BIOTICS
    B.1.3.4CountrySpain
    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 supportAB-BIOTICS
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationAB-BIOTICS
    B.5.2Functional name of contact pointClinical Trials Information
    B.5.3 Address:
    B.5.3.1Street AddressESADECREAPOLIS, Av. de la Torre Blanca, 57 - Of. 3B06
    B.5.3.2Town/ citySant Cugat del Vallès
    B.5.3.3Post code08172
    B.5.3.4CountrySpain
    B.5.4Telephone number34935946024
    B.5.6E-mailsalavert@ab-biotics.com
    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 No
    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 nameFERTYPHARM TEST
    D.3.4Pharmaceutical form Anticoagulant and preservative solution for blood
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIn vitro use (Noncurrent)
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNFERTYPHARM TEST
    D.3.9.3Other descriptive nameFERTYPHARM TEST
    D.3.10 Strength
    D.3.10.1Concentration unit h hour
    D.3.10.2Concentration typeup to
    D.3.10.3Concentration number1
    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 Yes
    D.3.11.13.1Other medicinal product typeFERTYPHARM TEST is a gentic test, it is not an IMP. It has been considered a clinical trial since the test results can modify doctor's intention to treat but not because it was an IMP
    D.8 Information on Placebo
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboAnticoagulant and preservative solution for blood
    D.8.4Route of administration of the placeboIn vitro use (Noncurrent)
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Infertility
    Infertilidad
    E.1.1.1Medical condition in easily understood language
    Infertility
    Infertilidad
    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
    The main objective of this study is to test the efficacy of a pharmacogenetics-driven approach, based on the information provided by the genetic polymorphism rs6166 in gene FSHR, to establish the doses of exogenous FSH (eFSH) in the COH protocols.
    El objetivo principal de este estudio es probar la eficacia de un enfoque de farmacogenética basada en la información proporcionada por el polimorfismo genético en FSHR gen - rs6166 , para establecer las dosis de FSH exógena (eFSH) en los protocolos de COH.
    E.2.2Secondary objectives of the trial
    • Describe the frequency of the analyzed polymorphisms in the population included in the pre-treatment visit
    • Evaluate the discrepancies and similarities between the eFSH dosage recommendations according to the routine clinical measures and the genotype of the patient.
    • Study the association of the patient’s genotype with the quality of the response to the COH.
    • Study the association of the patient’s genotype with the IVF overall outcome (i.e. pregnancies and live births)
    • Evaluate the utility of using the pharmacogenetic information to select the eFSH dose, as perceived by the researchers.
    • Genotype other genetic markers that have been previously associated with response to COH .
    • Describir la frecuencia de los polimorfismos analizados en la población incluida en la visita de pre-tratamiento
    • Evaluar las discrepancias y similitudes entre las recomendaciones de dosificación eFSH de acuerdo con las medidas clínicas de rutina y el genotipo del paciente.
    • Estudiar la asociación del genotipo del paciente con la calidad de la respuesta a la HOC.
    • Estudiar la asociación del genotipo del paciente con el resultado general de la fecundación in vitro (es decir, los embarazos y nacimientos vivos)
    • Evaluar la utilidad de usar la información farmacogenética para seleccionar la dosis eFSH, según la percepción de los investigadores.
    • Genotipo de otros marcadores genéticos que han sido previamente asociados con la respuesta a la HOC.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Normally ovulating infertile women, aged up to 38 years old
    • With BMI 18-28
    • FSH values < 10 mUI/mL
    • AMH values > 0.7 ng/mL
    • Undergoing ovarian stimulation with exogenous gonadotropins in fresh IVF procedures (the protocol type indicated should be defined as short, combined (FSH and LH) with GnRH antagonists )
    • Infertility cause: male infertility, tubal damage, and combinations of the aforementioned
    • Who has at least one COH cycle without BLcG positive and in which a standard protocol stimulation was used with combined Gonadotropins
    • Mujeres infértiles que estén ovulando normalmente, hasta la edad de 38 años
    • Con el IMC 18-28
    • Los valores de FSH <10 mUI / ml
    • Los valores de AMH> 0,7 ng / ml
    • sometidas a estimulación ovárica con gonadotropinas exógenas en los procedimientos de FIV frescos (el tipo de protocolo indicado se debería definir como corto, combinado (FSH y LH) con antagonistas de GnRH)
    • causas infertilidad: la infertilidad masculina, daño en las trompas, y combinaciones de lo anterior
    • ¿Quién tiene al menos un ciclo de COH sin BLcG positivo y en el que se utilizó un protocolo estándar de estimulación con gonadotropinas combinadas
    E.4Principal exclusion criteria
    • Patients who do not give their written informed consent to participate in the study
    • Patients who refuse to collect a blood sample, necessary for the obtaining of their genetic profile
    • Patients with an infertility cause other than tubal damage or male infertility (patients with pathological conditions potentially affecting their ovarian response, such premature ovarian failure, as endometriosis (at any stage) and polycystic ovarian syndrome)
    • Los pacientes que no den su consentimiento informado por escrito para participar en el estudio
    • Los pacientes que se niegan a recoger una muestra de sangre, necesaria para la obtención de su perfil genético
    • Los pacientes con una causa infertilidad excepción de los daños de trompas o la infertilidad masculina (pacientes que presentan patologías que puedan afectar a su respuesta ovárica, como insuficiencia ovárica prematura, como la endometriosis (en cualquier etapa) y el síndrome de ovario poliquístico)
    E.5 End points
    E.5.1Primary end point(s)
    To assess the efficacy of the pharmacogenetic-driven approach in the selection of the eFSH dose during the COH, the main variable will be the number of follicles on the rHCG application day.
    Para evaluar la eficacia del enfoque farmacogenético guiado en la selección de la dosis de FSH durante la COH, la variable principal será el número de folículos en el día de aplicación HCG.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The end of the study is defined as the last visit to the last recruited patient.
    El final del estudio se define como la última visita al último paciente reclutado.
    E.5.2Secondary end point(s)
    • Frequency of polymorphisms, through genetic analysis results
    • COH quality, number of follicles > 17mm on the rHCG application day, number of mature retrieved oocytes, number of embryos and embryos quality in agreement of ASEBIR (Asociación para el Estudio de la Biología de la Reproducción) criteria [35]
    • IVF overall outcome, by measuring the implantation and pregnancy rates, and number of live births. Confirmation of pregnancy will be performed by measuring serum HCG (hormone chorionic gonadotropin) at least 15 days after embryo transfer (ET) and also the fetal heartbeat 6 weeks after ET.
    • Predictive algorithm.
    • La frecuencia de polimorfismos, a través de los resultados de análisis genéticos
    • La calidad del COH, número de folículos> 17 mm en el día de la aplicación rhCG, número de ovocitos recuperados maduros, número de embriones y embriones de calidad de acuerdo de ASEBIR (Asociación para el Estudio de la Biología de la Reproducción) criterios [35]
    • FIV resultado global, mediante la medición de la implantación y las tasas de embarazo, y el número de nacidos vivos. La confirmación del embarazo se realizará mediante la medición de HCG en suero (hormona gonadotropina coriónica) por lo menos 15 días después de la transferencia de embriones (TE) y también el latido del corazón fetal 6 semanas después de la TE.
    • El algoritmo predictivo.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The end of the study is defined as the last visit to the last recruited patient.
    El final del estudio se define como la última visita al último paciente reclutado.
    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 No
    E.6.10Pharmacogenetic Yes
    E.6.11Pharmacogenomic Yes
    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 No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other Yes
    E.8.1.7.1Other trial design description
    EVALUACIÓN DE LA HIPÓTESIS
    HYPOTHESIS TESTING
    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
    prueba de hipótesis en 2 alternativas:eficacia de la farmacogenética vs enfoque no farmacogenético
    hypothesis testing in 2 alternatives: the efficacy of PGx vs non-PGx approach.
    E.8.2.4Number of treatment arms in the trial1
    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
    The end of the study is defined as the last visit to the last recruited patient.
    El final del estudio se define como la última visita al último paciente reclutado.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months3
    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 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: 40
    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 state40
    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 Decision2017-05-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-03-13
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2018-09-03
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