Flag of the European Union EU Clinical Trials Register Help

Clinical trials

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   43871   clinical trials with a EudraCT protocol, of which   7290   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     

    < Back to search results

    Print Download

    Summary
    EudraCT Number:2020-001069-35
    Sponsor's Protocol Code Number:IIBSP-EDA-2020-18
    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:2021-07-08
    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 number2020-001069-35
    A.3Full title of the trial
    Impact of Exercise and Mediterranean diet vs Aspirin on live-birth rate and cardiovascular programming in In Vitro Fertilization (MEDITATE-IVF): a Randomized Study.
    Impacto del Ejercicio y Dieta Mediterránea vs Aspirina en la tasa de nacidos vivos y el programado cardiovascular en Fecundación in Vitro (MEDITATE-IVF): ensayo aleatorizado.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Impact of Exercise and Mediterranean diet vs Aspirin on live-birth rate and cardiovascular programming in In Vitro Fertilization (MEDITATE-IVF)
    Impacto del Ejercicio y Dieta Mediterránea vs Aspirina en la tasa de nacidos vivos y el programado cardiovascular en Fecundación in Vitro (MEDITATE-IVF)
    A.3.2Name or abbreviated title of the trial where available
    MEDITATE-IVF
    MEDITATE-IVF
    A.4.1Sponsor's protocol code numberIIBSP-EDA-2020-18
    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 supportInstituto de Salud Carlos III, Acción Estratégica en Salud, Proyectos de Investigación en Salud, PI20/001504
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationInstitut de Recerca H. Santa Creu i Sant Pau.
    B.5.2Functional name of contact pointUICEC Sant Pau
    B.5.3 Address:
    B.5.3.1Street AddressSant Quintí 77-79
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08041
    B.5.3.4CountrySpain
    B.5.4Telephone number+34935537636
    B.5.5Fax number+34935537856
    B.5.6E-mailuicec@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 Tromalyt
    D.2.1.1.2Name of the Marketing Authorisation holderMEDA PHARMA, S.L
    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 nameTromalyt
    D.3.4Pharmaceutical form Capsule
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNACETYLSALICYLIC ACID
    D.3.9.1CAS number 50-78-2
    D.3.9.4EV Substance CodeSUB12730MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(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
    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
    Cumulative live-birth rate.
    Tasa acumulativa de nacidos vivos.
    E.1.1.1Medical condition in easily understood language
    Live-birth rate.
    Tasa o porcentaje de bebés nacidos vivos
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    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 the impact of exercise and Mediterranean diet vs LDA vs no intervention 6 months previous to ICF, on cumulative live-birth rate.
    Evaluar el impacto del ejercicio físico y dieta mediterránea vs LDA vs no intervención 6 meses previo a la ICF en la tasa acumulativa de nacidos vivos.
    E.2.2Secondary objectives of the trial
    -To evaluate basal CV risk parameters in women awaiting IVF procedures. -To evaluate CV risk parameters in women awaiting IVF procedures 6 months after pre-conception interventions. -To evaluate placental function biomarkers in the 1st and 3rd trimester of all study groups. -To evaluate maternal cardiac function parameters upon inclusion, previous to IVF, at 1st and 3rd trimester of pregnancy and compare between study groups. -To evaluate foetal cardiac function parameters at 3rd trimester of pregnancy and compare between study groups. -To describe the incidence of adverse perinatal outcomes, both maternal and foetal, in the study groups.
    -Evaluar los parámetros basales de riesgo cardiovascular en mujeres esperando procedimientos IVF. - Evaluar los parámetros basales de riesgo cardiovascular en mujeres esperando procedimientos IVF 6 meses después de intervenciones pre-conceptivas. -Evaluar biomarcadores de función placentaria en el primer y tercer trimestre en todos los grupos de estudio. -Evaluar los parámetros de función cardíaca materna des de la inclusión, previo a la IVF, al primer trimestre y tercer trimestre de embarazo y comparar entre grupos de estudio. -Describir la incidencia de resultados perinatales adversos (tanto maternos como fetales) en todos los grupos de estudio.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    Patients with primary infertility justifying IVF treatment, who wish to become pregnant, aged between 18 and ˂38 years, candidates for single embryo transfer in day 5, who give written consent when invited to participate in the study protocol.
    Pacientes con infertilidad primaria que justifique el tratamiento IVF, las cuales busquen quedarse embarazadas y tengan entre 18 y ˂38 años. Candidatas para transferencia de un solo embrión en día 5 y que den su consentimiento informado para participar en el protocolo de estudio.
    E.4Principal exclusion criteria
    Low ovarian reserve (defined as anti-Mullerian hormone ˂1 ng/mL), pregnancy at the moment of inclusion, presence of comorbidities that contraindicate IVF, pregnancy or childbirth, known allergies to any of the interventions to be applied, previous unsuccessful IVF cycles, probability of loss to follow-up, probability of delivery occurring in another hospital or centre.
    Reserva ovárica baja (definida cómo hormona anti Mulleriana a niveles inferiores a 1ng/mL), embarazo al momento de inclusión, presencia de comorbilidades que contraindiquen la IVF, embarazo o haber dado a luz, alergias conocidas a alguno de los procedimientos que se aplicarán, ciclos previos IVF fallidos, probabilidad de pérdida de seguimiento y probabilidad de que el parto ocurra en otro hospital o centro.
    E.5 End points
    E.5.1Primary end point(s)
    Cumulative live-birth rate: defined as the number of deliveries that result in a live born neonate, expressed per 100 embryo transfers.
    Tasa acumulativa de nacidos vivos: definida como el número de partos que resultan en un neonato vivo, expresado por 100 transferencias embrionarias.
    E.5.1.1Timepoint(s) of evaluation of this end point
    When delivery occurs.
    Cuando el parto ocurra.
    E.5.2Secondary end point(s)
    Adverse perinatal outcome: defined as the presence of either of the following: miscarriage, stillbirth, low birth weight, preterm birth, preeclampsia, congenital malformations and/or admission to neonatal ICU. • High risk of PE (preeclampsia) according to first trimester screening: a logistic regression-based predictive model for early and late onset PE will be used, according to a validated algorithm including maternal characteristics, levels of pregnancy-associated plasma protein-A (PAPP-A) and free β-Human chorionic gonadotropin (β-hCG) at 8-12 weeks, and blood pressure and uterine artery Doppler at 11.0-13.6 weeks. Details of this screening method have previously been described and are available for clinical use. • Preeclampsia: categorized according to the guidelines of the Royal College of Obstetricians and Gynaecologists. Briefly, hypertension will be defined as the repeated measurement of systolic blood pressure of ≥140 mm Hg (Korotkoff I) and diastolic blood pressure of ≥90 mm Hg (Korotkoff V). Proteinuria will be defined as the excretion of 300 mg protein or greater per day in the 24-hour urine collection or a repeated dipstick of ≥1+. Pregnancy-induced hypertension (PIH) will be defined as the new onset of hypertension after 20 weeks of gestation, and preeclampsia (PE) will be defined when additional proteinuria was diagnosed according to International Society for the Study of Hypertension in Pregnancy. • Incidence of adverse events and serious adverse events summarized by treatment groups.
    Resultado perinatal adverso: se define como la presencia de alguno de los siguientes: aborto, nacimiento del bebé fallecido, bajo peso al nacer, parto prematuro, preeclampsia, malformaciones congénitas y/o ingreso en la UCI neonatal. • Alto riesgo de PE (preeclampsia) según un screening en el primer trimestre; un modelo predictivo de logística basada en regresión para PE de comienzo temprano y tardío se empleará, acordemente con un algoritmo validado que incluya características maternas, niveles de proteínas plasmáticas A asociadas a embarazo (PAPP-A) y gonadotropina coriónica β humana (β-hCG) libre a las 8-12 semanas además de presión sanguínea y de arteria uterina Doppler a las 11.0-13.6 semanas. Los detalles de este método de screening han sido previamente descritos y están disponibles actualmente para uso clínico. • Preeclampsia: categorizada acordemente a las guías del Real Colegio de Obstetras y Ginecólogos. Brevemente, se define la hipertensión como la medición repetida de presión sanguínea sistólica de ≥140 mm Hg (Korotkoff I) y de presión sanguínea diastólica de ≥90 mm Hg (Korotkoff V). La proteinuria se define como la excreción de 300mg de proteína o superior por día en la colección de orina durante 24 horas o repetidamente en una varilla graduada de ≥1+. La hipertensión inducida por el embarazo (PIH) se define como un nuevo inicio de hipertensión tras 20 semanas de gestación, y la preeclampsia (PE) se define cuando se diagnostica proteinuria de forma adicional según la Sociedad Internacional para el Estudio de la Hipertensión en el embarazo. • Incidencia de eventos adversos y eventos adversos graves agrupados por grupos de tratamiento.
    E.5.2.1Timepoint(s) of evaluation of this end point
    • It will be registered when the adverse outcome happens, if it may. • First pregnancy trimester. • It will be registered when the adverse outcome happens, if it may. • It will be registered when the adverse outcome happens, if it may.
    Se registra cuando el resultado adverso ocurre, en caso de que ocurriera. • Primer trimestre de embarazo. • Se registra cuando el resultado adverso ocurre, en caso de que ocurriera. • Se registra cuando el resultado adverso ocurre, en caso de que ocurriera.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis Yes
    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 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 Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    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) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial3
    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 último paciente
    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: 750
    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 Yes
    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 state750
    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 Decision2021-07-06
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-16
    P. End of Trial
    P.End of Trial StatusOngoing
    For support, Contact us.
    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

    European Medicines Agency © 1995-Sun May 05 18:40:25 CEST 2024 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA