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    Summary
    EudraCT Number:2019-001830-32
    Sponsor's Protocol Code Number:RC31/17/0448
    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:2019-07-12
    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 number2019-001830-32
    A.3Full title of the trial
    Phase III Trial to assess impact of ultra-long versus long down-regulation protocol on IVF/ICSI outcomes in infertile women presenting with adenomyosis.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Impact of ultra-long versus long down-regulation protocol on IVF/ICSI outcomes in adenomyosis.
    A.3.2Name or abbreviated title of the trial where available
    ADENOFIV
    A.4.1Sponsor's protocol code numberRC31/17/0448
    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 SponsorUniversity Hospital Toulouse
    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 supportProgramme Hospitalier de Recherche Clinique National 2017
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity Hospital Toulouse
    B.5.2Functional name of contact pointcaroline Peyrot
    B.5.3 Address:
    B.5.3.1Street AddressDirection de la Recherche et de l'Innovation, 2 rue Viguerie TSA 80035
    B.5.3.2Town/ cityToulouse
    B.5.3.3Post code31059
    B.5.4Telephone number0561778486+33
    B.5.5Fax number0561778411+33
    B.5.6E-mailpeyrot.c@chu-toulouse.fr
    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
    D.2.1.1.2Name of the Marketing Authorisation holderIpsen Pharma, 65 quai Georges-Gorse
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameDecapeptyl
    D.3.4Pharmaceutical form Powder and solvent for solution 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.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 Vivelledot
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Pharma
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameVIVELLEDOT
    D.3.4Pharmaceutical form Transdermal patch
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPTransdermal 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.IMP: 3
    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
    D.2.1.1.2Name of the Marketing Authorisation holderIPSEN Pharma
    D.2.1.2Country which granted the Marketing AuthorisationFrance
    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 nameDecapeptyl
    D.3.4Pharmaceutical form Powder and solvent for solution for 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 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
    Infertilty in women with adenomyosis.
    E.1.1.1Medical condition in easily understood language
    Infertilty in women with adenomyosis.
    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 ultra-long protocol versus long protocol on the live birth rate after first or second IVF/ICSI attempt in infertile women with adenomyosis.
    E.2.2Secondary objectives of the trial
    To compare ultra-long and long protocols efficacy after first or second IVF/ICSI in terms of:
    -uterine volume reduction following pituitary down-regulation
    -low responders rate
    -biochemical pregnancy
    -implantation rate
    -clinical pregnancy
    -clinical pregnancy with fetal heart beat
    -ongoing pregnancy at the end of first trimester
    -first trimester miscarriage

    To assess treatment safety and tolerability in both arms in terms of specific menopause-like symptoms at the end of down-regulation treatment,
    To assess Adverse Events occurrence during down-regulation treatment, during IVF/ICSI attempt, during pregnancy (including ectopic pregnancy occurrence) and at delivery (maternal and perinatal complications for mother and child until 6 weeks post-partum).
    To assess placental malposition occurrence (defined as the presence of placenta previa or accreta diagnosed on third trimester US examination or at time of delivery).
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1) suspected adenomyosis on high quality TV US or focal or diffuse adenomyosis defined as a thickening of the JZ to more than 12mm on previous MRI (<6 months)
    2) infertility of any cause requiring IVF or ICSI
    3) infertility period of at least 1 year except for women with history of deep infiltrating endometriosis or bilateral salpingectomy
    4) age >18 and < 40 years
    5) complete fertility workup comprising for women hormone serum measurement (AMH, estradiol, FSH, LH), high quality transvaginal ultrasound and, when applicable, hysterosalpingography, diagnostic laparoscopy or hysteroscopy
    6) first or second IVF or ICSI attempt
    7) absence of severe premature ovarian insufficiency defined by antral follicle count < 8 and AMH < 1ng/ml
    8) meet the criteria from the French law to be included in an assisted reproductive technique program
    9) informed written consent for both women and men
    10) social security cover for both women and men
    E.4Principal exclusion criteria
    1) absence of adenomyosis (defined as a thickening of the JZ to more than 12mm) on pelvic MRI
    2) other potential causes of implantation failure: leiomyoma, endometrial polyp, not removed hydrosalpinx, malformed uterus (unicornis, bicornis, septate, duplex), antiphospholipid syndrome
    3) medical contraindication to study treatments (GnRH agonist and add-back therapy)
    4)history of previous prolonged GnRH agonist treatment (> 3 months) within 6 months prior study treatment start
    5) women taking prohibited concomitant treatments and not able to stop them for the study period
    6) medical contraindication to assisted reproductive technique and/or pregnancy including: uncontrolled type I and II diabetes; undiagnosed liver disease or dysfunction; renal insufficiency; history of deep venous thrombosis, pulmonary embolism or cerebrovascular accident; uncontrolled hypertension; known symptomatic heart disease; history of or suspected cervical carcinoma, endometrial carcinoma, ovarian carcinoma or breast carcinoma; undiagnosed vaginal bleeding; genetic abnormalities
    7) positive plasma viral load for HIV, HCV or HBV for one (or both) in the couple during the year before inclusion
    8) participation in another research study including an exclusion period which has not expired at the time of screening
    9) patients subject to a judicial safeguard order, guardianship or trusteeship.
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy endpoint is a live birth after first or second IVF/ICSI attempt defined as delivery of one or more live-born infant.
    E.5.1.1Timepoint(s) of evaluation of this end point
    From 22 weeks of gestation
    E.5.2Secondary end point(s)
    Secondary efficacy endpoints include:
    -Uterine volume reduction between Ultra sound measurements: at baseline and at time of ovarian stimulation onset
    -Occurrence of poor responders defined as women with <3 matures follicles or serum estradiol <500
    -Biochemical pregnancy defined as serum ßhCG ≥ 100 IU/l
    -Implantation rate defined as the ratio ”number of gestational sacs/number of transferred embryos” on transvaginal ultrasound
    -Clinical pregnancy defined as the presence of one or more gestational sacs on transvaginal ultrasound
    -Clinical pregnancy with fetal heart beat defined as the presence of at least one fetus with heart beat on transvaginal ultrasound
    -Ongoing pregnancy defined as a live pregnancy on first trimester ultrasound examination
    -First trimester miscarriage occurrence defined as a pregnancy loss before 12 weeks of gestation among patients with a clinical pregnancy

    Secondary safety endpoints include:
    -Occurrence of menopause-like symptoms using the Menopause Rating Scale
    -Occurrence of ovarian hyperstimulation syndrome (OHS)
    -Occurrence of pregnancy and post-partum complications
    -Occurrence of neonatal complications
    -Occurrence of any other adverse Event
    E.5.2.1Timepoint(s) of evaluation of this end point
    -Uterine volume reduction:at baseline and at time of ovarian stimulation onset
    -Occurrence of poor responders:at the time of ovulation triggering
    -Biochemical pregnancy:14 days following follicular aspiration
    -Implantation rate and clinical pregnancy:5 weeks after follicular aspiration
    -Clinical pregnancy with fetal heart beat:7 weeks after embryo transfer
    -Ongoing pregnancy:at 12 weeks of gestation
    -First trimester miscarriage occurrence:before 12 weeks of gestation
    -Occurrence of menopause-like symptoms:at the end of the GnRH agonist treatment
    -Occurrence of ovarian hyperstimulation syndrome
    -Occurrence of pregnancy, neonatal and post-partum complications: until 6 weeks post-partum
    -Occurrence of any other Adverse Event: during the entire study period
    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 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 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 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 concerned14
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years4
    E.8.9.1In the Member State concerned months3
    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: 674
    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 state674
    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
    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 Decision2019-12-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2019-11-18
    P. End of Trial
    P.End of Trial StatusOngoing
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