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    Summary
    EudraCT Number:2014-003986-11
    Sponsor's Protocol Code Number:1401-MAD-004-IO
    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:2015-04-27
    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 number2014-003986-11
    A.3Full title of the trial
    Prospective, double-blinded, randomized clinical trial to evaluate the potential benefitial effect of resveratrol for preventing the ovarian hyperstimulation syndrome.
    Ensayo clínico randomizado contra placebo, prospectivo, unicéntrico, doble-ciego para evaluar el efecto del resveratrol como tratamiento preventivo del síndrome de hiperestimulación ovárica
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The role of resveratrol for preventing the ovarian hyperstimulation syndrome
    Resveratrol como tratamiento preventivo del Síndrome de Hiperestimulación Ovárica
    A.3.2Name or abbreviated title of the trial where available
    The role of resveratrol for preventing the ovarian hyperstimulation syndrome
    Resveratrol como tratamiento preventivo del Síndrome de Hiperestimulación Ovárica
    A.4.1Sponsor's protocol code number1401-MAD-004-IO
    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 SponsorIVI Madrid
    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 supportIVI Madrid
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationIVI Madrid
    B.5.2Functional name of contact pointIsrael Ortega
    B.5.3 Address:
    B.5.3.1Street AddressAvenida del Talgo, 68
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28023
    B.5.3.4CountrySpain
    B.5.4Telephone number0034911802900
    B.5.5Fax number0034911802910
    B.5.6E-mailIsrael.Ortega@ivi.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 Resveratrol
    D.2.1.1.2Name of the Marketing Authorisation holderSoria Natural
    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 nameResveratrol
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    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 Yes
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    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 placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Resveratrol may prevent the incidence of ovarian hyperstimulation syndrome by reducing the expression of VEGF and estradiol, improving the haemoconcentration and ascitis Re
    Resveratrol puede prevenir la aparición de un síndrome de hiperestimulación ovárica mediante la reducción en la expresión de VEGF y estradiol, mejorando la hemoconcentración y el incremento de volumen de líquido ascítico típico de este cuadro clínico.
    E.1.1.1Medical condition in easily understood language
    Resveratrol may prevent the incidence of ovarian hyperstimulation syndrome
    Resveratrol puede prevenir la aparición de un síndrome de hiperestimulación ovárica.
    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
    Evaluate the effect of resveratrol on VEGF levels
    Evaluar el efecto del resveratrol en los niveles de VEGF
    E.2.2Secondary objectives of the trial
    Evaluate the effect of resveratrol on haemoconcentration, estradiol levels and ascitis
    Evaluar el efecto del resveratrol en la hemoconcentración, niveles de estradiol y en volumen de líquido ascítico.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Egg donors who meet the following criteria:

    1. Number of follicles (>12 mm) > o = 21 in the last scan previous ovum pick-up.
    2. Number of retrieved oocytes > o =21.
    Donantes de ovocitos que deben cumplan los siguientes dos criterios:

     - Número de folículos (> 12 mm) > o = 21 en la ecografía del día de la inducción de la ovulación
    - Número de ovocitos recuperados > o = 21.
    E.4Principal exclusion criteria
    Exclusión criteria for egg donation: >35 years, polycystic ovary syndrome, endometriosis, severe systematic pathology, positive serologies for BHV, CHV o HIV, or altered karyotype.
    Los criterios de exclusión para donación de ovocitos: >35 años, SOP, endometriosis, patología sistémica grave, serologías positivas para VHB, VHC o VIH, cariotipo alterado
    E.5 End points
    E.5.1Primary end point(s)
    Levels of VEGF
    Niveles séricos de VEGF
    E.5.1.1Timepoint(s) of evaluation of this end point
    3, 6 and 9 days after ovulation triggering with GnRH agonist
    A los 3, 6 y 9 días tras la inducción de la ovulación con análogo de la GnRH
    E.5.2Secondary end point(s)
    Haemococentration, estradiol levels, levels of ascitic fluid, laboratory parameters
    Hemoconcentración, Niveles de estradiol, Volumen de líquido ascítico, Determinaciones bioquímicas
    E.5.2.1Timepoint(s) of evaluation of this end point
    3, 6 and 9 days after ovulation triggering with GnRH agonist
    A los 3, 6 y 9 días tras la inducción de la ovulación con análogo de la GnRH
    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 No
    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 No
    E.8.1.4Double blind Yes
    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) No
    E.8.2.2Placebo Yes
    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 sujeto
    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 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: 70
    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 state70
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 70
    F.4.2.2In the whole clinical trial 70
    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 Decision2016-10-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2016-05-09
    P. End of Trial
    P.End of Trial StatusCompleted
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