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    Summary
    EudraCT Number:2022-000382-41
    Sponsor's Protocol Code Number:PFL2021
    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:2022-03-24
    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 number2022-000382-41
    A.3Full title of the trial
    Protection of the luteal phase by means of progesterone in assisted reproduction procedures. Comparison of different routes of administration and study of predictive parameters of reproductive success.
    Protección de la fase lútea mediante progesterona en procedimientos de reproducción asistida. Comparación de diferentes vías de administración y estudio de parámetros predictivos de éxito reproductivo.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Protection of the luteal phase by means of progesterone in assisted reproduction procedures. Comparison of different routes of administration and study of predictive parameters of reproductive success.
    Protección de la fase lútea mediante progesterona en procedimientos de reproducción asistida. Comparación de diferentes vías de administración y estudio de parámetros predictivos de éxito reproductivo.
    A.4.1Sponsor's protocol code numberPFL2021
    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 SponsorReproducción Bilbao. Ginegorama S.L.
    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 supportReproducción Bilbao. Ginegorama S.L.
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationReproducción Bilbao. Ginegorama S.L.
    B.5.2Functional name of contact pointCoinvestigator
    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.5.4Telephone number0034946 11 12 13
    B.5.6E-mailagarcia@reproduccionbilbao.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 Cyclogest 400 mg
    D.2.1.1.2Name of the Marketing Authorisation holderGedeon Richter Plc.
    D.2.1.2Country which granted the Marketing AuthorisationHungary
    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 nameCyclogest
    D.3.4Pharmaceutical form Vaginal capsule
    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) 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 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 Yes
    D.3.11.13.1Other medicinal product typeSex hormones and modulators of the genital system; Progestogens; Derivatives of (4) pregnene
    D.IMP: 2
    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 Prolutex 25 mg
    D.2.1.1.2Name of the Marketing Authorisation holderProlutex
    D.2.1.2Country which granted the Marketing AuthorisationItaly
    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 nameProlutex
    D.3.4Pharmaceutical form Injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous 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) 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 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
    In this project, we propose the performance of a comparative study of different patterns of gestagenic coverage in in vitro fertilization (IVF) cycles with deferred transfer of genetically selected blastocysts. To do this, in the context of an IVF procedure, a cycle will be carried out with ovarian stimulation, with subsequent oocyte induction and retrieval (as is done routinely and according to protocol).
    Planteamos en el presente proyecto la realización de une estudio comparativo de diferentes pautas de cobertura gestagénica en ciclos de fecundación in vitro (FIV) con transferencia diferida de blastocistos genéticamente seleccionados. Para ello, se procederá, en el contexto de un procedimiento de FIV, a la realización de un ciclo es estimulación ovárica, con posterior inducción y recuperación ovocitaria (tal como se realiza de forma rutinaria y protocolizada).
    E.1.1.1Medical condition in easily understood language
    Performance of a comparative study of different patterns of gestagenic coverage in in vitro fertilization (IVF) cycles with deferred transfer of genetically selected blastocysts.
    Estudio comparativo de diferentes pautas de cobertura gestagénica en ciclos de fecundación in vitro (FIV) con transferencia diferida de blastocistos genéticamente seleccionados.
    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
    To evaluate the efficacy in terms of evolutionary pregnancy of the transfer of genetically selected embryos based on the different gestagenic preparation protocols described.
    Evaluar la eficacia en términos de embarazo evolutivo de la transferencia de embriones genéticamente seleccionados en función de los diferentes protocolos de preparación gestagénica descritos.
    E.2.2Secondary objectives of the trial
    1. Assess the relationship between plasma levels of progesterone and endometrial thickness at the time of embryo transfer.
    2. Assess the relationship between plasma levels of progesterone and endometrial pattern at the time of embryo transfer.
    3. Assess the relationship between plasma levels of progesterone and route of administration (subcutaneous vs. Vaginal) on the day of B-HCG determination.
    4. Assess the relationship between plasma levels of progesterone and ongoing pregnancy.
    5. Assess the relationship between different parameters (age, BMI, number of oocytes obtained, number of developed blastocysts, percentage of euploid blastocysts) with evolutionary pregnancy rates.
    6. Establish a hormonal coverage protocol with diagnostic and prognostic criteria for the future of assisted reproduction.
    1. Valorar la relación entre niveles plasmáticos de progesterona y grosor endometrial en el momento de la transferencia embrionaria.
    2. Valorar la relación entre niveles plasmáticos de progesterona y patrón endometrial en el momento de la transferencia embrionaria.
    3. Valorar la relación entre niveles plasmáticos de progesterona y vía de administración (subcutánea vs. Vaginal) el día de la determinación de B-HCG.
    4. Valorar la relación entre niveles plasmáticos de progesterona y embarazo evolutivo.
    5. Valorar la relación entre diferentes parámetros (edad, IMC, número de ovocitos obtenidos, número de blastocistos desarrollados, porcentaje de blastocistos euploides) con las tasas de embarazo evolutivo.
    6. Establecer un protocolo de cobertura hormonal con criterios diagnósticos y pronósticos cara al futuro de la reproducción asistida.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Women over 18 and under 42 years of age scheduled to undergo an in vitro fertilization cycle with deferred transfer of a blastocyst after preimplantation genetic screening (PGT-A).
    • Presence of at least one transferable euploid embryo (embryos classified as possible mosaics are not included).
    • Absence of medical-surgical contraindications for a follicular puncture of an IVF cycle.
    • Absence of uterine fibroids
    • Agree with the fulfillment of the objectives of the study
    • Mujeres de más de 18 años y menores de 42 programadas para la realización de un ciclo de fecundación in vitro con transferencia diferida de un blastocisto tras screening genético preimplantacional (PGT-A).
    • Presencia de, al menos, un embrión euploide transferible (no se incluyen embriones clasificados como posibles mosaicos).
    • Ausencia de contraindicaciones médico‐quirúrgicas para una punción folicular de un ciclo FIV.
    • Ausencia de miomas uterinos
    • Estar de acuerdo con el cumplimiento de los objetivos del estudio
    E.4Principal exclusion criteria
    • Presence of uterine fibroids.
    • Previous history of early pregnancy loss.
    • Previous history of uterine surgery
    • Hypersensitivity or intolerance to the exogenous administration of Estrogens or Progesterone or any of the excipients contained in the medication.
    • Contraindication for the exogenous administration of Estrogens or Progesterone.
    • Presencia de miomas uterinos.
    • Historia previa de pérdidas gestacionales precoces.
    • Historia previa de cirugía uterina
    • Hipersensibilidad o intolerancia a la administración exógena de Estrógenos o Progesterona o cualquiera de los excipientes contenidos en la medicación.
    • Contraindicación para la administración exógena de Estrógenos o Progesterona.
    E.5 End points
    E.5.1Primary end point(s)
    - Date of delivery
    - Fecha del parto
    E.5.1.1Timepoint(s) of evaluation of this end point
    15 months
    15 meses
    E.5.2Secondary end point(s)
    - Gestation weeks
    - Type of delivery
    - Weight of the newborn
    - Sex of the newborn
    - Incidents and possible complications
    - Semanas de gestación
    - Tipo de parto
    - Peso del neonato
    - Sexo del neonato
    - Incidencias y posibles complicaciones
    E.5.2.1Timepoint(s) of evaluation of this end point
    15 months
    15 meses
    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) 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 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
    randomizado prospectivo, controlado comparativo
    randomized prospective, comparative controlled
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo No
    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
    Gestational monitoring is carried out in the center itself until week 12 of the same. As of that week, the patient can be monitored in the same center or in another (both public and private networks).
    El seguimiento gestacional se efectúa en el propio centro hasta la semana 12 del mismo. A partir de esa semana la paciente puede ser controlada en el mismo centro o en otro (tanto de la red pública como privada).
    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 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: 100
    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 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 state100
    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 Decision2022-10-05
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2022-08-22
    P. End of Trial
    P.End of Trial StatusOngoing
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