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   44334   clinical trials with a EudraCT protocol, of which   7366   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:2020-000247-32
    Sponsor's Protocol Code Number:MAXINOVO
    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:2020-05-28
    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 number2020-000247-32
    A.3Full title of the trial
    ACTIVATION OF PRIMORDIAL FOLLICULES AMONG WOMEN WITH POOR OVARIAN RESERVE BY USIN GROWTH FACTORS.
    ACTIVACION DE FOLICULOS PRIMORDIALES EN MUJERES CON BAJA RESERVA OVARICA MEDIANTE FACTORES DE CRECIMIENTO.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    ACTIVATION OF PRIMORDIAL FOLLICULES AMONG WOMEN WITH POOR OVARIAN RESERVE BY USIN GROWTH FACTORS.
    ACTIVACION DE FOLICULOS PRIMORDIALES EN MUJERES CON BAJA RESERVA OVARICA MEDIANTE FACTORES DE CRECIMIENTO.
    A.4.1Sponsor's protocol code numberMAXINOVO
    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 SponsorREPRODUCCION BILBAO (GINEGORAMA SL)
    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 supportREPRODUCCION BILBAO (GINEGORAMA SL)
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationREPRODUCCION BILBAO (GINEGORAMA SL)
    B.5.2Functional name of contact pointREPRODUCCION BILBAO
    B.5.3 Address:
    B.5.3.1Street AddressMORGAN 2B
    B.5.3.2Town/ cityBILBAO
    B.5.3.3Post code48014
    B.5.3.4CountrySpain
    B.5.6E-mailgbarrenetxea@reproduccionbilbao.es
    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 Yes
    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 namePLASMA AUTOLOGO
    D.3.2Product code PLASMA AUTOLOGO
    D.3.4Pharmaceutical form
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPVaginal use
    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) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) Yes
    D.3.11.3.1Somatic cell therapy medicinal product Yes
    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 Yes
    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
    The reproductive capacity of women depends on two factors: the number of follicles in the ovaries and the quality of oocytes within those follicles. Premature ovarian failure (POF) and poor ovarian response represent two challenges to ovarian stimulation protocols used in assisted reproduction. Currently, treatment of POF is extremely difficult. Classically, the number of oocytes is predefined at birth with no new gametes to be developed along the life of a woman.
    La capacidad reproductiva de una mujer depende del número d e folículos y de la calidad de los ovocitos dentro de los mismos. El fallo ovárico prematuro representa un reto en los protocolos de estimulación ovárica dentro del contexto de los tratamientos de reproducción asistida. Clásicamente, se ha considerado que una mujer nace con una dotación folicular y ovocitaria predeterminada y que a lo largo de la vida de la misma no se generan nuevos ovocitos.
    E.1.1.1Medical condition in easily understood language
    Autologus platelet-rich plasma (PRP) has been used in many medical conditions, including POP. But, after more than 15 years of clinical use of this therapy, no randomized trials have been designed.
    El tratamiento mediante plasma enriquecido en proteínas se ha utilizado en muy diferentes áreas de la medicina, pero no existen estudios adecuadamente diseñados en los casos de fallo ovárico.
    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
    Increase the number of available oocytes and their quality in patients with low ovarian response after a controlled ovarian stimulation procedure by activating quiescent primary follicles by the action of endogenous growth factors. This will allow to recover more oocytes and of higher quality, as well as reduce the number of stimulations in this type of patients.
    Aumentar el número de ovocitos disponibles y su calidad en pacientes con baja respuesta ovárica tras un procedimiento de estimulación ovárica controlada mediante la activación de folículos primordiales quiescentes por acción de factores de crecimiento endógenos. Esto permitirá recuperar más ovocitos y de mayor calidad, así como reducir el número de estimulaciones en este tipo de pacientes.
    E.2.2Secondary objectives of the trial
    Increase knowledge about the mechanisms of action of growth factors on the initial ovarian reserve of the patient and the activation of quiescent primordial follicles.
    Determine the effect of the dose and concentration of growth factors on the functional ovarian reserve pool.
    Evaluate the effect of growth factors on oocyte quality and subsequently on the embryo in its different stages of development.
    Evaluate the increase in the number of oocytes available in patients treated with growth factors after a new controlled ovarian stimulation procedure.
    Develop a therapeutic tool for patients with low ovarian response with which to reduce the number of cycles of controlled ovarian stimulation during ART.
    Reduce the number of stimulations necessary to achieve a certain number of oocytes.
    Improve oocyte quality and success rates of ART in patients with low ovarian response.
    Incrementar el conocimiento sobre los mecanismos de acción de factores de crecimiento sobre la reserva ovárica inicial de la paciente y la activación de folículos primordiales quiescentes.
    Determinar el efecto de las dosis y concentración de los factores de crecimiento sobre el pool de reserva ovárica funcional.
    Evaluar el efecto de los factores de crecimiento sobre la calidad ovocitaria y sobre el embrión en sus diferentes estadios.
    Evaluar el aumento en el núm. de ovocitos disponibles en las pacientes tratadas con factores de crecimiento tras un nuevo procedimiento de estimulación ovárica controlada.
    Desarrollar una herramienta terapéutica destinada a pacientes con baja respuesta ovárica con la que reducir el núm de ciclos de estimulación ovárica controlada.
    Reducir el núm. de estimulaciones necesario para conseguir un núm. determinado de ovocitos.
    Mejorar calidad de los ovocitos y tasas de éxito de los TRA en pacientes con baja respuesta ovárica.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Women over 18 years of age and under 42 who meet the criteria for low functional ovarian reserve (Poseidon Criteria) programmed to perform successive cycles of oocyte accumulation.
    • Women undergoing ovarian stimulation in order to accumulate oocytes for an assisted reproduction procedure (ICSI cycle with preimplantation genetic screening, PGT-S).
    • Absence of hematological or infectious pathology
    • Absence of medical-surgical contraindications for a follicular puncture of an IVF cycle.
    • Absence of a history of intra-abdominal infectious pathology
    • Absence of endometriosis
    • Agree with the fulfillment of the objectives of the study
    • Mujeres de más de 18 años y menores de 42 que cumplan con los criterios de baja reserva ovárica funcional (Criterios Poseidon) programadas para la realización de ciclos sucesivos de acumulación ovocitaria.
    • Mujeres sometidas a estimulación ovárica con la finalidad de acumular ovocitos de cara a un procedimiento de reproducción asistida (ciclo ICSI con screening genético preimplantacional, PGT-S).
    • Ausencia de patología hematológica o infecciosa
    • Ausencia de contraindicaciones médico-quirúrgicas para una punción folicular de un ciclo FIV.
    • Ausencia de antecedentes de patología infecciosa intra-abdominal
    • Ausencia de endometriosis
    • Estar de acuerdo con el cumplimiento de los objetivos del estudio
    E.4Principal exclusion criteria
    History of intra-abdominal infectious pathology.
    • Absolute or relative contraindication for a follicular puncture.
    • Diagnosis of endometriosis.
    • Antecedentes de patología infecciosa intraabdominal.
    • Contraindicación absoluta o relativa para una punción folicular.
    • Diagnóstico de endometriosis.
    E.5 End points
    E.5.1Primary end point(s)
    Number of ovocits
    Número de ovocitos
    E.5.1.1Timepoint(s) of evaluation of this end point
    Oocytes extraction
    Extracción de los ovocitos
    E.5.2Secondary end point(s)
    Pregnancy rates
    Tasas de embarazo
    E.5.2.1Timepoint(s) of evaluation of this end point
    Once the 12th week of gestation is reached
    Una vez alcanzada la semana 12 de gestación.
    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 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) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open No
    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 No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    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 trial occurs once the 3rd stimulation has been performed on the patients under test.
    El final del ensayo se produce una vez realizada la 3ª estimulación a las pacientes objeto del ensayo.
    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 months6
    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: 60
    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 state60
    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
    G.4 Investigator Network to be involved in the Trial: 1
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-11-03
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-10-21
    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-Fri May 02 06:48:33 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA