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    Summary
    EudraCT Number:2017-002267-18
    Sponsor's Protocol Code Number:APTE
    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:2017-08-21
    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 number2017-002267-18
    A.3Full title of the trial
    EFFICACY AND SAFETY OF THE CONCENTRATE OF AUTOMOTIVE RICH PLASMA IN GROWTH FACTORS IN THE TREATMENT OF THE FINE ENDOMETRY IN PATIENTS SUBMITTED TO TRANSFER OF CRIO-PRESERVED EMBRYOS: CLINICAL TRIAL III.
    EFICACIA Y SEGURIDAD DEL CONCENTRADO DE PLASMA AUTÓLOGO RICO EN FACTORES DE CRECIMIENTO EN EL TRATAMIENTO DEL ENDOMETRIO FINO EN PACIENTES SOMETIDAS A TRANSFERENCIA DE EMBRIONES CRIO-PRESERVADOS: ENSAYO CLÍNICO FASE III.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    EFFICACY AND SAFETY OF THE CONCENTRATE OF AUTOMOTIVE RICH PLASMA IN GROWTH FACTORS IN THE TREATMENT OF THE FINE ENDOMETRY IN PATIENTS SUBMITTED TO TRANSFER OF CRIO-PRESERVED EMBRYOS: CLINICAL TRIAL III.
    EFICACIA Y SEGURIDAD DEL CONCENTRADO DE PLASMA AUTÓLOGO RICO EN FACTORES DE CRECIMIENTO EN EL TRATAMIENTO DEL ENDOMETRIO FINO EN PACIENTES SOMETIDAS A TRANSFERENCIA DE EMBRIONES CRIO-PRESERVADOS: ENSAYO CLÍNICO FASE III.
    A.4.1Sponsor's protocol code numberAPTE
    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 SponsorSara Rafael Fernández
    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 supportSara Rafael Fernández
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationSara Rafael Fernández
    B.5.2Functional name of contact pointSponsor
    B.5.3 Address:
    B.5.3.1Street AddressCalle del Prof Martín Lagos, s/n
    B.5.3.2Town/ cityMadrid
    B.5.3.3Post code28040
    B.5.3.4CountrySpain
    B.5.4Telephone number349130030003776
    B.5.5Fax number349133035153515
    B.5.6E-mailfibucicec.hcsc@salud.madrid.org
    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 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 namePRP (Obtenido por PRGF-Endoret)
    D.3.4Pharmaceutical form Blood fraction modifier
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPVaginal use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNPlatelet Rich Plasma
    D.3.9.3Other descriptive nameAUTOLOGOUS PLASMA
    D.3.9.4EV Substance CodeSUB117286
    D.3.10 Strength
    D.3.10.1Concentration unit ml millilitre(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number0.4
    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) Yes
    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 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
    infertile women
    mujeres infertiles
    E.1.1.1Medical condition in easily understood language
    infertile women
    mujeres infertiles
    E.1.1.2Therapeutic area Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10056204
    E.1.2Term In vitro fertilisation
    E.1.2System Organ Class 10042613 - Surgical and medical procedures
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level LLT
    E.1.2Classification code 10016463
    E.1.2Term Fertility decreased female
    E.1.2System Organ Class 100000024038
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10021928
    E.1.2Term Infertility female
    E.1.2System Organ Class 10038604 - Reproductive system and breast disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10021926
    E.1.2Term Infertility
    E.1.2System Organ Class 10038604 - Reproductive system and breast disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    Determine the percentage of women who achieve an endometrial thickness equal to or greater than 7 mm after administration of PRGF
    Determinar el porcentaje de mujeres que logra alcanzar un grosor endometrial igual o superior a 7 mm tras la administración de PRGF.
    E.2.2Secondary objectives of the trial
    Determine the endometrial thickness after intrauterine administration of autologous platelet concentrate.
    Analyze the incidence of biochemical pregnancy
    Analyze the percentage of women who achieve clinical gestation.
    Evaluate the safety of PRGF administration.
    Determine the number of newborn
    Determine the number of abortions.
    Determine the number of registered ectopic pregnancies.
    Determine the number of women requiring administration of a second dose of PRGF.
    To compare the number of pregnancies among women who received a dose of PRGF compared to those who received two doses
     Determinar el grosor endometrial tras la administración intrauterina de concentrado autólogo de plaquetas.
     Analizar la incidencia de embarazo bioquímico tras transferencia embrionaria en pacientes a las que se administró PRGF.
     Analizar el porcentaje de mujeres que logran gestación clínica.
     Evaluar la seguridad de la administración de PRGF.
     Determinar el número de RN (recién nacido) vivo.
     Determinar el número de abortos.
     Determinar el número de embarazos ectópicos registrados.
     Determinar el número de mujeres que precisan de la administración de una segunda dosis de PRGF.
     Comparar el número de embarazos entre las mujeres que recibieron una dosis de PRP frente a aquellas que recibieron dos dosis
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
     Women who signed informed consent.
     Women who understand the Spanish language.
     Mujeres que firmen consentimiento informado.
     Mujeres que entiendan el idioma castellano.
    E.4Principal exclusion criteria
     Thrombopenia.
     Coagulation problems.
    Congenital or acquired uterine malformations that reduce embryo implantation or term gestation.
    Ovarian tumors.
    Benign uterine tumors require surgical treatment
     Local acute inflammatory diseases
     Patients with malignant tumors requiring chemotherapy.
     Patients with acute or chronic infectious or inflammatory diseases requiring active treatment with drugs that may interfere with implantation and gestation.
     Trombopenia.
     Problemas de coagulación.
     Malformaciones uterinas congénitas o adquiridas que impidan la implantación embrionaria o la gestación a término.
     Tumores ováricos.
     Tumores benignos uterinos que requieran tratamiento quirúrgico.
     Enfermedades inflamatorias agudas locales (por ejemplo Enfermedad Inflamatoria Pélvica).
     Pacientes con tumores malignos que requieran la administración de quimioterapia.
     Pacientes con enfermedades infecciosas o inflamatorias graves agudas o crónicas que requieran tratamiento activo con fármacos que puedan interferir en la implantación y la gestación.
    E.5 End points
    E.5.1Primary end point(s)
    Percentage of women who achieve an endometrial thickness equal to or greater than 7 mm
    Porcentaje de mujeres que logra alcanzar un grosor endometrial igual o superior a 7 mm
    E.5.1.1Timepoint(s) of evaluation of this end point
    3 days after treatment
    3 días tras el tratamiento
    E.5.2Secondary end point(s)
     Thrombopenia.
     Coagulation problems.
    Congenital or acquired uterine malformations that reduce embryo implantation or term gestation.
    Ovarian tumors.
    Benign uterine tumors require surgical treatment
     Local acute inflammatory diseases
     Patients with malignant tumors requiring chemotherapy.
     Patients with acute or chronic infectious or inflammatory diseases requiring active treatment with drugs that may interfere with implantation and gestation.
     Trombopenia.
     Problemas de coagulación.
     Malformaciones uterinas congénitas o adquiridas que impidan la implantación embrionaria o la gestación a término.
     Tumores ováricos.
     Tumores benignos uterinos que requieran tratamiento quirúrgico.
     Enfermedades inflamatorias agudas locales (por ejemplo Enfermedad Inflamatoria Pélvica).
     Pacientes con tumores malignos que requieran la administración de quimioterapia.
     Pacientes con enfermedades infecciosas o inflamatorias graves agudas o crónicas que requieran tratamiento activo con fármacos que puedan interferir en la implantación y la gestación.
    E.5.2.1Timepoint(s) of evaluation of this end point
    3 days after the treatment
    14 days after the treatment
    Labour
    3 dias despues el tratamiento
    14 dias despues el tratamiento
    Parto
    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 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 No
    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 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.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned4
    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
    UPUV
    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 months0
    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: 12
    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 state1
    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 Decision2017-11-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-11-15
    P. End of Trial
    P.End of Trial StatusOngoing
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