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    Summary
    EudraCT Number:2018-003106-29
    Sponsor's Protocol Code Number:RANDOS
    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:2018-09-25
    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 number2018-003106-29
    A.3Full title of the trial
    Feasibility and efficacy of a new ovarian stimulation regimen with RANDom start, use of corifollitropin alpha and progestin protocol for Oocyte donorS
    Faisabilité et efficacité d’un protocole de stimulation ovarienne à début ultra flexible et ultra simplifié pour les donneuses d’ovocytes (random-start et protocole avec blocage par progestatifs en phase folliculaire)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Ovarian stimulation protocol with ultra flexible and ultra simplified start for oocyte donors
    Protocole de stimulation ovarienne à début ultra flexible et ultra simplifié pour les donneuses d’ovocytes
    A.3.2Name or abbreviated title of the trial where available
    RANDOS
    A.4.1Sponsor's protocol code numberRANDOS
    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 SponsorCHI Créteil
    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 supportMSD Laboratory
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationCHI Créteil
    B.5.2Functional name of contact pointClinical Research Center
    B.5.3 Address:
    B.5.3.1Street Address40 avenue de Verdun
    B.5.3.2Town/ cityCréteil
    B.5.3.3Post code94000
    B.5.3.4CountryFrance
    B.5.4Telephone number15702261233
    B.5.5Fax number14517515633
    B.5.6E-mailm.brussieux.chic@gmail.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 DESOGESTREL
    D.2.1.1.2Name of the Marketing Authorisation holderMYLAN
    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 nameDESOGESTREL
    D.3.4Pharmaceutical form Coated tablet
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPOral 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
    infertility
    Infertilité
    E.1.1.1Medical condition in easily understood language
    Assisted Reproductive Techniques (ART)
    Aide médicale à la procréation
    E.1.1.2Therapeutic area Body processes [G] - Reproductive physiologi cal processes [G08]
    MedDRA Classification
    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
    The main objective of the study is to compare the number of oocytes punctured after a progestogen-induced ovarian stimulation protocol, random start, depending on the phase of the cycle on the day of the beginning of ovarian stimulation.
    L'objectif principal de l'étude est de comparer le nombre d'ovocytes ponctionnés après un protocole de stimulation ovarienne avec blocage progestatif, à départ aléatoire, en fonction de la phase du cycle le jour du début de la stimulation ovarienne.
    E.2.2Secondary objectives of the trial
    - Show the effectiveness of LH peak blockade by oral progesterone administration
    - To show the effectiveness of LH peak blockade by the administration of oral progesterone irrespective of the phase of the menstrual cycle on the day of stimulation initiation
    - To describe the evolution of the hormonal parameters of the patients under treatment by Desogestrel (LH, progesterone, Estradiolemia)
    - To evaluate the differences of the stimulation parameters (duration, doses, number of injections ..) according to the groups of randomization [in connection with the main objective]
    - Montrer l’efficacité du blocage du pic de LH par l’administration de progestérone per os
    - Montrer l’efficacité du blocage du pic de LH par l’administration de progestérone per os quelle que soit la phase du cycle menstruel le jour du démarrage de la stimulation
    - Décrire l’évolution des paramètres hormonaux des patientes sous traitement par Désogestrel (LH, progestérone, Estradiolémie)
    - Evaluer les différences des paramètres de stimulation (durée, doses, nombre d’injections..) selon les groupes de randomisation [en lien avec l’objectif principal]
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    - Donor of oocytes having spontaneous and regular menstrual cycles, and having taken no hormonal treatment (in particular contraceptive) during the cycle preceding the donation.
    - Patient with normal ovarian reserve with antral follicle count> 8,
    - BMI between 18 and 32
    - Regular natural menstrual cycles, and absence of hormonal treatment during the cycle preceding the donation cycle
    - Major patient
    - Affiliation to social security
    - Donneuse d'ovocytes ayant des cycles menstruels spontanés et réguliers, et n’ayant pris aucun traitement hormonal (en particuliers contraceptif) durant le cycle précédant le don.
    - Patiente ayant une réserve ovarienne normale avec un compte de follicules antraux > 8,
    - IMC entre 18 et 32
    - Cycles menstruels naturels réguliers, et absence de traitement hormonal durant le cycle précédant le cycle de don
    - Patiente majeure
    - Affiliation à la sécurité sociale
    E.4Principal exclusion criteria
    - Stage 3-4 endometriosis
    - ovarian cyst> 30 mm,
    - Polycystic ovary syndrome
    - Patient under tutorship or curatorship
    - Endométriose stade 3-4
    - Kyste de l'ovaire > 30 mm,
    - Syndrome des ovaires polykystiques
    - Patient sous tutelle ou curatelle
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint is the number of oocytes punctured after ovarian stimulation as described above, regardless of the phase of the menstrual cycle at the time of injection of corifollitropin alpha.
    Le critère de jugement principal est le nombre d'ovocytes ponctionnés après une stimulation ovarienne telle que décrite ci-dessus, quelle que soit la phase du cycle menstruel au moment de l’injection de la corifollitropin alpha.
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the day of oocytes retrieval
    Le jour de la récupération des ovocytes
    E.5.2Secondary end point(s)
    - the number of mature oocytes,
    - The occurrence of a premature LH surge, and its frequency
    - The occurrence of moderate or severe ovarian hyperstimulation syndrome
    - The number of injections needed,
    - The number of r-FSH units required for ovarian stimulation,
    - The number of days of stimulation.
    - Le nombre d'ovocytes matures,
    - La survenue d’un pic prématuré de LH, et sa fréquence
    - La survenue d’un syndrome d'hyperstimulation ovarienne modérée ou sévère
    - Le nombre d'injections nécessaires,
    - Le nombre d'unités de r-FSH nécessaires à la stimulation ovarienne,
    - Le nombre de jours de stimulation.
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the day of oocytes retrieval
    Le jour de la récupération des ovocytes
    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) 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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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
    random-start
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    random-start
    E.8.2.4Number of treatment arms in the trial5
    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 concerned5
    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
    LVLP
    Dernière visite du dernier sujet
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years2
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years2
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial 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: 110
    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 No
    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 state110
    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
    aucun
    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 Decision2019-01-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2017-12-07
    P. End of Trial
    P.End of Trial StatusOngoing
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