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    Summary
    EudraCT Number:2019-003645-16
    Sponsor's Protocol Code Number:2019_0012
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2019-10-18
    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 ConcernedFrance - ANSM
    A.2EudraCT number2019-003645-16
    A.3Full title of the trial
    Benefit of the GnRH agonist before frozen embryo transfer in patients with endometriosis and / or adenomyosis: randomized prospective study
    Bénéfice de l’agoniste de la GnRH avant un transfert d’embryon congelé chez les patientes atteintes d’endométriose et/ou adénomyose : étude prospective randomisée
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Benefit of treatment with a GnRH agonist (neurohormone) prior to frozen embryo transfer in patients with endometriosis (endometrial disease) and / or adenomyosis (another form of endometriosis)
    Bénéfice du traitement par un agoniste de la GnRH (neurohormone) avant un transfert d'embryon congelé chez les patientes atteintes d’endométriose (maladie de l'endomètre) et/ou adénomyose (une autre forme d'endométriose)
    A.3.2Name or abbreviated title of the trial where available
    DECATEC
    DECATEC
    A.4.1Sponsor's protocol code number2019_0012
    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 SponsorHopital Foch
    B.1.3.4CountryFrance
    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 supportHopital Foch
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationHopital Foch
    B.5.2Functional name of contact pointDRCI
    B.5.3 Address:
    B.5.3.1Street Address40 rue Worth
    B.5.3.2Town/ citySuresnes
    B.5.3.3Post code92150
    B.5.4Telephone number+330146251175
    B.5.5Fax number+330146252766
    B.5.6E-maildrci-promotion@hopital-foch.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 L.P. 3mg
    D.2.1.1.2Name of the Marketing Authorisation holderIPSEN Pharma
    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 Powder and solvent for suspension for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntramuscular use
    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
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Frozen embryo transfer in patients with endometriosis and/or adenomyosis
    Transfert d’Embryon Congelé chez les patientes atteintes d’endométriose et/ou adénomyose
    E.1.1.1Medical condition in easily understood language
    Frozen embryo transfer in patients with endometriosis (endometrial disease) and / or adenomyosis (other type of endometriosis)
    Transfert d’Embryon Congelé chez les patientes atteintes d’endométriose (maladie de l'endomètre) et/ou adénomyose (autre type de l'endométriose)
    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 assess the impact of long-acting GnRH agonist administration on clinical pregnancy rate
    Evaluer l’impact de l’administration d’agoniste de la GnRH à effet prolongé sur le taux de grossesse clinique
    E.2.2Secondary objectives of the trial
    To evaluate the impact of long-acting GnRH agonist administration on:
    - implantation rate
    - miscarriage rate.
    To measure the side effects inherent to the administration of GnRH agonist
    Evaluer l’impact de l’administration d’agoniste de la GnRH à effet prolongé sur :
    - le taux d’implantation
    - sur le taux de fausse couche
    Mesurer les effets secondaires inhérents à l’administration d’agoniste de la GnRH
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Women aged 18 to 36 years (women ≥18 years to <36 years) with endometriosis and / or adenomyosis
    - Having benefited from IVF / ICSI with freeze all and for whom the TEC of a blastocyst is planned
    - A normal uterine cavity
    - An MRI showing endometriosis and / or adenomyosis during the inclusion visit (MRI performed after patient selection)
    - Having signed a consent form
    - Being affiliated to a Health Insurance Plan.
    Femmes âgées de 18 à 36 ans (Femmes ≥18ans à < 36ans) atteintes d’endométriose et/ou adénomyose
    Ayant bénéficié d’une FIV/ICSI avec freeze all et pour lesquelles le TEC d’un blastocyste est planifié
    Une cavité utérine normale
    Une IRM objectivant l’endométriose et/ou l’adénomyose au cours de la visite d’inclusion (IRM réalisée après sélection des patientes)
    Ayant signée un formulaire de consentement
    Etant affiliée à un régime d’Assurance Maladie.
    E.4Principal exclusion criteria
    - Patient aged <18 years and ≥ 36 years
    - BMI> 35
    - History of implantation failures (≥ 2)
    - Endometrial alterations: synechiae, polyps, myomas, hyperplasia, hematometry
    - known hydrosalpinx uni or bilateral
    - MRI showing no endometriosis or adenomyosis
    - Hypersensitivity to GnRH, GnRH analogues, or any of the excipients of DECAPEPTYL® L.P. 3 mg (see section 6.1 of the SPC in Appendix 2)
    - Known hypersensitivity to estradiol
    - Known hypersensitivity to progesterone
    - Known hypersensitivity to acetylsalicylic acid or other nonsteroidal anti-inflammatory drugs
    - Known hypersensitivity to folic acid
    - Known hypersensitivity to cefixime or an antibiotic in the cephalosporin group
    - Known hypersensitivity to levofloxacin or any other quinolone
    - History of tendinopathies related to the administration of fluoroquinolones
    - Epilepsy
    - Hypersensitivity to contrast agents for MRI
    - Known or suspected breast cancer or history of breast cancer
    - Known or suspected genital tract cancer or history of genital cancer
    - known or suspected estrogen-dependent malignant neoplasms
    - Undiagnosed genital haemorrhage
    - Untreated endometrial hyperplasia
    - History of idiopathic venous thrombo-embolic accident or evolving venous thrombo-embolic event (deep vein thrombosis, pulmonary embolism)
    - Recent or evolving arterial thromboembolic stroke (eg angina, myocardial infarction)
    - Acute liver disease or history of liver disease, until hepatic tests are normalized
    - Severe renal insufficiency
    - Severe, uncontrolled heart failure
    - Evolutionary gastroduodenal ulcer
    - History of asthma caused by the administration of salicylates or substances of similar activity, especially nonsteroidal anti-inflammatory drugs
    - Porphyria
    - GnRH Agonist DECAPEPTYL® L.P. administered within 6 months prior to transfer
    - To be deprived of liberty or under guardianship
    -Pregnancy and breast feeding.
    - Patiente âgée de < 18ans et ≥ 36 ans
    - ICM > 35
    - Antécédent d’échecs d’implantation (≥ 2)
    - Altérations endométriales : synéchies, polypes, myomes, hyperplasie, hématométrie
    - Hydrosalpinx connu uni ou bilatéral
    - IRM ne montrant pas d’endométriose ni adénomyose
    - Hypersensibilité à la GnRH, aux analogues de la GnRH, ou à l’un des excipients de la spécialité DECAPEPTYL® L.P. 3 mg (cf. rubrique 6.1 du RCP en annexe 2)
    - Hypersensibilité connue à l’estradiol
    - Hypersensibilité connue à la progestérone
    - Hypersensibilité connue à l’acide acétylsalicylique ou aux autres anti-inflammatoires non stéroïdiens
    - Hypersensibilité connue à l’acide folique
    - Hypersensibilité connue à la cefixime ou à un antibiotique du groupe des céphalosporines
    - Hypersensibilité connue à la levofloxacine ou à toute autre quinolone
    - Antécédents de tendinopathies liées à l’administration de fluoroquinolones
    - Epilepsie
    - Hypersensibilité aux produits de contraste pour IRM
    - Cancer du sein connu ou suspecté ou antécédents de cancer du sein
    - Cancer de l’appareil génital connu ou suspecté ou antécédents de cancer de l’appareil génital
    - Tumeurs malignes oestrogéno-dépendantes connues ou suspectées
    - Hémorragie génitale non diagnostiquée
    - Hyperplasie endométriale non traitée
    - Antécédent d'accident thrombo-embolique veineux idiopathique ou accident thrombo-embolique veineux en évolution (thrombose veineuse profonde, embolie pulmonaire)
    - Accident thrombo-embolique artériel récent ou en évolution (exemple : angor, infarctus du myocarde)
    - Affection hépatique aiguë ou antécédents d'affection hépatique, jusqu'à normalisation des tests hépatiques
    - Insuffisance rénale sévère
    - Insuffisance cardiaque sévère non contrôlée
    - Ulcère gastro-duodénal évolutif
    - Antécédents d'asthme provoqué par l'administration de salicylés ou de substances d'activité proche, notamment les anti-inflammatoires non stéroïdiens
    - Porphyrie
    - GnRH agoniste DECAPEPTYL® L.P. administré dans les 6 mois qui précèdent le transfert
    - Etre privée de liberté ou sous tutelle
    - Grossesse et allaitement.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the clinical pregnancy rate (with cardiac activity) assessed in both groups at last visit ultrasound
    Le critère d’évaluation principal consiste au taux de grossesse clinique (avec une activité cardiaque) évalué dans les deux groupes lors de l’échographie réalisée à la dernière visite
    E.5.1.1Timepoint(s) of evaluation of this end point
    At study end.
    A la fin de l'étude
    E.5.2Secondary end point(s)
    - Successful implantation rate on the number of patients included
    - Rates of miscarriages on the number of patients included
    - Side effects related to treatment with DECAPEPTYL ® LP, 3 mg (IM)
    - Taux d’implantations réussies sur le nombre de patientes incluses
    - Taux de fausses couches sur le nombre de patientes incluses
    - Effets secondaires liés au traitement par DECAPEPTYL ® LP, 3 mg (IM)
    E.5.2.1Timepoint(s) of evaluation of this end point
    At study end.
    A la fin de l'étude
    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) 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 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) 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
    LPLV
    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 months15
    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: 180
    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 state180
    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
    Na
    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 Decision2020-02-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-01-14
    P. End of Trial
    P.End of Trial StatusOngoing
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