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    Summary
    EudraCT Number:2015-002521-19
    Sponsor's Protocol Code Number:FSH_IMEN
    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:2015-08-12
    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 number2015-002521-19
    A.3Full title of the trial
    "Pilot study on the effect of FSH treatment in epigenetic characteristics of sperm in infertile patients with severe oligozoospermia"
    ?Estudio piloto acerca del efecto del tratamiento con FSH en las características epigenéticas de los espermatozoides en pacientes infértiles con oligozoospermia severa?
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Study on the effect of FSH treatment in epigenetic sperm in infertile patients
    Estudio acerca del efecto del tratamiento con FSH en la epigenetica de los espermatozoides en pacientes infértiles.
    A.4.1Sponsor's protocol code numberFSH_IMEN
    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 de Investigación Sanitaria La Fe
    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 DE INVESTIGACION SANITARIA LA FE
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationINSTITUTO DE INVESTIGACION SANITARIA LA FE
    B.5.2Functional name of contact pointUREC
    B.5.3 Address:
    B.5.3.1Street AddressAV. FERNANDO ABRIL MARTORELL 106
    B.5.3.2Town/ cityVALENCIA
    B.5.3.3Post code46026
    B.5.3.4CountrySpain
    B.5.4Telephone number34961246611
    B.5.5Fax number34961246620
    B.5.6E-mailINVESTIGACION_CLINICA@IISLAFE.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 FSH_IMEN
    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.3.1Product nameBRAVELLE
    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 INND06269
    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 typeequal
    D.3.10.3Concentration number150
    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 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
    Male infertility
    Infertilidad Masculina
    E.1.1.1Medical condition in easily understood language
    Male infertility
    Infertilidad Masculina
    E.1.1.2Therapeutic area Diseases [C] - Male diseases of the urinary and reproductive systems [C12]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 18.0
    E.1.2Level LLT
    E.1.2Classification code 10017399
    E.1.2Term FSH
    E.1.2System Organ Class 100000004848
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Determine genomic imprinting (epigenetic modification) in a number of infertile male patients with alteration in their semen (oligozoospermia) against a group of fertile men, assessing the effect on these changes by administering FSH in the group with infertility
    Determinar la impronta genómica (modificación epigenética) en una serie de pacientes varones infértiles con alteración en su espermiograma (oligozoospermia) frente a un grupo de varones fértiles, valorando el efecto sobre estas modificaciones al administrar FSH en el grupo con infertilidad.
    E.2.2Secondary objectives of the trial
    -Evaluate the main characteristics of semen of infertile patients before and
    after treatment with FSH.
    - Assess the modifications of the hormones involved in training
    sperm of infertile patients before and after treatment.
    - Analyze the outcome of assisted reproduction treatment in those patients
    which they were administered FSH
    - Valorar las principales características del espermiograma de pacientes infértiles antes y
    después del tratamiento con FSH.
    - Valorar las modificaciones de las hormonas involucradas en la formación de
    espermatozoides de aquellos pacientes con infertilidad antes y después del tratamiento.
    - Analizar el resultado de los tratamientos de reproducción asistida en aquellos pacientes a los
    que se les ha administrado FSH.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Age 30-40 years
    2. Total sperm concentration (concentration / mL million
    x volume in ml) from 1-10 million (oligozoospermia) at least 2
    Semen obtained with a period of sexual abstinence 2-4
    days and at least a separation between 7 days.
    3. Caucasian.
    4. Inability of the couple to achieve a pregnancy after one year of
    sex without using any birth control.
    5. 2-12 FSH IU / mL.
    6. Total Testosterone greater than 300 ng / mL and bioavailable testosterone,
    calculated from albumin, Sex Hormone Binding Globuling -
    SHBG- greater than 145 ng / dL
    1. Edad entre 30-40 años
    2. Concentración total de espermatozoides (concentración en millones/mL
    x volumen en mL) entre 1-10 millones (oligozoospermia) en al menos 2
    espermiogramas obtenidos con un periodo de abstiencia sexual de 2-4
    días y al menos una separación entre ambos de 7 días.
    3. Raza caucásica.
    4. Incapacidad de la pareja para conseguir un embarazo tras un año de
    relaciones sexuales sin utilización de ningún método anticonceptivo.
    5. FSH 2-12 UI/mL.
    6. Testosterona total mayor de 300 ng/mL y testosterona biodisponible,
    calculada a partir de la albúmina, Sexual Hormone Binding Globuling ?
    SHBG-, mayor de 145 ng/dL
    E.4Principal exclusion criteria
    1. Age between 30-40 years.
    2. Caucasian.
    3. Concentration and sperm motility above percentile
    50 according to the parameters of the fifth edition of the Organization
    World Health Organization (WHO) in at least two semen in the
    least 2 semen obtained with a period of abstinence
    sexual 2-4 days and at least a separation between 7 days.
    4. increased seminal volume of 1 ml.
    5. Estradiol less than 50 pg / mL
    6. FSH less than 4.5 IU / L.
    7. Total Testosterone greater than 300 ng / dL and bioavailable testosterone
    greater than 145 ng / dL.
    8. Have not been vasectomized.
    9. Have been parents in the past five years.
    1. Edad entre 30-40 años.
    2. Raza caucásica.
    3. Concentración y motilidad de espermatozoides por encima del percentil
    50 según los parámetros de la quinta edición de la Organización
    Mundial de la Salud (OMS) en al menos dos espermiogramas en al
    menos 2 espermiogramas obtenidos con un periodo de abstiencia
    sexual de 2-4 días y al menos una separación entre ambos de 7 días.
    4. Volumen seminal mayor de 1 mL.
    5. Estradiol menor de 50 pg/mL
    6. FSH menor de 4.5 IU/L.
    7. Testosterone total mayor de 300 ng/dL y testosterone biodisponible
    mayor de 145 ng/dL.
    8. No hayan sido vasectomizados.
    9. Hayan sido padres en los últimos cinco años.
    E.5 End points
    E.5.1Primary end point(s)
    Changes in methylation of sperm DNA or epigenetic changes detectable after treatment.
    Cambios en la metilación del DNA del espermatozoide o Cambios epigenéticos detectables tras de tratamiento
    E.5.1.1Timepoint(s) of evaluation of this end point
    After 12 weeks
    Después de 12 semanas
    E.5.2Secondary end point(s)
    - Clinical pregnancy rate defined as the identification of at least one sack
    gestational fetal heartbeat on transvaginal ultrasound in week 6-7 after
    transfer embrión.-
     - FSH, LH, testosterone, bioavailable testosterone after treatment.
    - Count, concentration and mobility of sperm ejaculated after
    the treatmen
    - Tasa de embarazo clínico definida como la identificación de al menos un saco
    gestacional con latido fetal en la ecografía transvaginal en la semana 6-7 tras la
    transferencia del embrión.-
    - FSH, LH, testosterona y testosterona biodisponible tras el tratamiento.
    - Recuento, concentración y movilidad de los espermatozoides del eyaculado tras
    el tratamiento
    E.5.2.1Timepoint(s) of evaluation of this end point
    After treatment.
    Después del tratamiento.
    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 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 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) Yes
    E.7.4Therapeutic use (Phase IV) No
    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
    CONTROLADO COMPARADO CON EL GRUPO DE VOLUNTARIOS SANOS
    CONTROLLED COMPARED WITH HEALTHY VOLUNTEERS GROUP
    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
    GRUPO DE VOLUNTARIOS SANOS SIN TRATAMIENTO
    HEALTHY VOLUNTEERS GROUP WITHOUT TREATMENT
    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
    LVLS
    LVLS
    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 months7
    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: 45
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female No
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    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 state45
    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
    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 Decision2015-10-19
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2015-08-05
    P. End of Trial
    P.End of Trial StatusOngoing
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