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    Summary
    EudraCT Number:2021-002467-22
    Sponsor's Protocol Code Number:FSD-PSE-2021-09
    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:2021-06-11
    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 number2021-002467-22
    A.3Full title of the trial
    Dual Trigger vs. GnRH-a Trigger for Elective Fertility Preservation. A randomized controlled trial.
    Doble descarga versus descarga con agonista de la GnRH para preservación de la fertilidad social. Ensayo controlado aleatorizado
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Dual Trigger for Elective Fertility Preservation
    Doble descarga en preservación de fertilidad social
    A.3.2Name or abbreviated title of the trial where available
    DUAL-T trial
    DUAL-T trial
    A.4.1Sponsor's protocol code numberFSD-PSE-2021-09
    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 SponsorFundacion Santiago Dexeus Font
    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 supportFundación Santiago Dexeus Font
    B.4.2CountrySpain
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationFundacion Santiago Dexeus Font
    B.5.2Functional name of contact pointUnidad de Apoyo a la Investigación
    B.5.3 Address:
    B.5.3.1Street AddressGran Via Carles III 71-75
    B.5.3.2Town/ cityBarcelona
    B.5.3.3Post code08028
    B.5.3.4CountrySpain
    B.5.4Telephone number34932274700
    B.5.6E-mailnacrod@dexeus.com
    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 Decapeptyl diario 0,1 mg polvo y disolvente para solución inyectable
    D.2.1.1.2Name of the Marketing Authorisation holderIpsen Pharma Sa
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInjection (Noncurrent)
    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.IMP: 2
    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.2.1.1.1Trade name Decapeptyl diario 0,1 mg polvo y disolvente para solución inyectable
    D.2.1.1.2Name of the Marketing Authorisation holderIpsen Pharma Sa
    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.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPInjection (Noncurrent)
    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.IMP: 3
    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 Ovitrelle 250 microgramos solución inyectable en pluma precargada.
    D.2.1.1.2Name of the Marketing Authorisation holderMerck Europe B.V.
    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.3.4Pharmaceutical form
    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 Yes
    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
    This study is a randomized controlled, superiority trial comparing the number of MII oocytes following final follicle maturation with dual trigger (250 μg rhCG + 0.2mg Triptorelin) or GnRH-a trigger (0.2mg Triptorelin) in women undergoing elective fertility preservation.
    Este estudio es un estudio controlado aleatorizado de superioridad para comparar el número de ovocitos MII tras maduración folicular con doble descarga (250 μg rhCG + 0.2mg Triptorelin) o descarga con GnRH-a (0.2mg Triptorelin) en mujeres que realizan preservación de fertilidad social
    E.1.1.1Medical condition in easily understood language
    To compare the number of mature oocytes (MII) retrieved after dual trigger and GnRH-a trigger in patients undergoing elective fertility preservation in a progestin-primed ovarian stimulation protocol.
    Comparar el número de ovocitos MII recuperados tras doble descarga y descarga simple con GnRH-a en pacientes que siguen preservación social en un protocolo de estimulación ovárica controlada
    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 compare the number of mature oocytes (MII) retrieved after dual trigger and GnRH-a trigger in patients undergoing elective fertility preservation in a progestin-primed ovarian stimulation protocol.
    Comparar el número de ovocitos MII recuperados tras doble descarga y descarga simple con GnRH-a en pacientes que siguen preservación social en un protocolo de estimulación ovárica controlada
    E.2.2Secondary objectives of the trial
    To compare the dual trigger and GnRH-a trigger regarding:
    1. Total number of oocytes retrieved
    2. Endocrine profile on the day after trigger (FSH, LH, Estradiol, progesterone)
    3. Incidence of OHSS
    Comparar la doble descarga y la descarga con GnRH-a en relación a:
    Número total de ovocitos recuperados ,
    perfil endocrinológico el día después de la descarga (FSH, LH, Estradiol, y Progesterona),
    y la indecencia de hiperestimulación ovárica
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • AFC < 20
    • Anti-Mullerian hormone (AMH) ≤ 3ng/ml (AMH result of up to one year will be valid)
    • Age ≤ 40 years
    • BMI > 18 and < 30 kg/m2
    • Willing to participate in the study
    • AFC < 20
    • Anti-Mullerian hormone (AMH) ≤ 3ng/ml (AMH hasta un año antes)
    • Age ≤ 40 years
    • BMI > 18 and < 30 kg/m2
    • Dispuesta a participar en el estudio
    E.4Principal exclusion criteria
    • Medically indicated fertility preservation
    • AFC ≥ 20
    • Polycystic ovarian syndrome (PCOS) according to the Rotterdam criteria
    • FSH ≥ 20
    • History of untreated autoimmune, endocrine or metabolic disorders
    • Contraindication for hormonal treatment
    • Recent history of severe disease requiring regular treatment (clinically significant concurrent medical condition that could compromise subject safety or interfered with the trial assessment).
    • Indicación de preservación de fertilidad médica
    • AFC ≥ 20
    • Síndrome de ovario poliquístico (Roterdam criteria)
    • FSH ≥ 20
    • Historia de enfermedad autoinmune, endocrina o metabólica no controlada
    • Contraindicación de tratamiento hormonal

    • Historia reciente de enfermedad severa que requiere tratamiento crónico que pudiera interferir con la seguridad del paciente o con el desarrollo del ensayo
    E.5 End points
    E.5.1Primary end point(s)
    To compare the number of MII oocytes retrieved after final oocyte maturation with dual trigger and GnRH-a trigger in patients undergoing elective fertility preservation.
    Comparar el número de ovocitos MII recuperados tras doble descarga y descarga simple con GnRH-a en pacientes que siguen preservación social en un protocolo de estimulación ovárica controlada
    E.5.1.1Timepoint(s) of evaluation of this end point
    About 34-36 hours thereafter oocyte pick-up will be performed.
    34-36 horas tras la descarga se realizará la punción folicular
    E.5.2Secondary end point(s)
    1. Total number of oocytes retrieved
    2. Endocrine profile on the day after trigger (FSH, LH, estradiol, progesterone)
    3. Incidence of OHSS
    1. Número total de ovocitos recuperados
    2. Perfil endocrino respecto (FSH, LH, estradiol, progesterona)
    3. Incidencia de hiperestimulación ovárica
    E.5.2.1Timepoint(s) of evaluation of this end point
    Total number of oocytes retrieved:About 34-36 hours thereafter oocyte pick-up will be performed.
    Endocrine profile on the day after trigger
    Incidence of OHSS: Untul 7 days after oocyte pick-up
    Número de Ovocitos recuperados:34-36 horas tras la descarga se realizará la punción folicular
    Perfil endocrino: el día despues de la descarga
    Incidencia de hiperestimulación ovárica. Hasta 7 días tras la punción
    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 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) 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
    LVLS
    LVLS
    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 months19
    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 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 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 Decision2021-07-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-06-30
    P. End of Trial
    P.End of Trial StatusOngoing
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