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    Summary
    EudraCT Number:2021-001399-40
    Sponsor's Protocol Code Number:RECHMPL20_0092
    National Competent Authority:France - ANSM
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2021-04-06
    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 number2021-001399-40
    A.3Full title of the trial
    Amlodipine interest in HRT (Hormone Replacement Therapy) cycle for frozen embryo transfer in the uterine pulsatility indices correction: double-blind randomized controlled trial
    Intérêt de l’amlodipine en cycle THS (Traitement Hormonal Substitutif) pour transfert d'embryon congelé dans la correction des indices de pulsatilité utérine: essai randomisé contrôlé en double aveugle
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Amlodipine interest on uterine pulsatility index for patients with Hormone Replacement Therapy for frozen embryo transfer .
    Intérêt de l’amlodipine sur les indices de pulsatilité utérine pour transfert d'embryon congelé avec Traitement Hormonal Substitutif
    A.3.2Name or abbreviated title of the trial where available
    AmlodIP
    AmlodIP
    A.4.1Sponsor's protocol code numberRECHMPL20_0092
    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 of Montpellier
    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 supportUNIVERSITY HOSPITAL of Montpellier
    B.4.2CountryFrance
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationUniversity hospital of Montpellier
    B.5.2Functional name of contact pointANNE CADENE
    B.5.3 Address:
    B.5.3.1Street Address39 avenue charles flahault, pavillon 32
    B.5.3.2Town/ cityMONTPELLIER
    B.5.3.3Post code34090
    B.5.3.4CountryFrance
    B.5.4Telephone number+330467330814
    B.5.5Fax number+3304339172
    B.5.6E-maila-cadene@chu-montpellier.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 AMLODIPINE
    D.2.1.1.2Name of the Marketing Authorisation holderARROW GENERIQUES
    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.3.4Pharmaceutical form Capsule
    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 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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    uterine arteries pulsalility index for patients awaiting frozen embryo transfer
    pulsalité des artères utérines chez les patientes avec un transfert d'embryon congelé
    E.1.1.1Medical condition in easily understood language
    uterine arteries blood pressure
    pression arterielle uterine
    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
    The main objective of our study is to assess the impact of a calcium channel blocker, amlodipine orally, versus placebo, on the measurement of uterine PIs in patients with a measurement of uterine PIs greater than 3, during hormone replacement therapy (HRT) for frozen embryo transfer (TEC) at the blastocyst stage (J5).
    L'objectif principal de notre étude est d’évaluer l’impact d'un inhibiteur calcique, l'amlodipine per os, versus placebo, sur la mesure des IP utérins chez des patientes ayant une mesure des IP utérins supérieure à 3, au cours d'un traitement hormonal substitutif (THS) pour transfert d'embryon congelé (TEC) au stade de blastocyste (J5).
    E.2.2Secondary objectives of the trial
    compare the success in terms of clinical pregnancy, miscarriage and live birth in the two groups and
    to assess the tolerance of amlodipine in normo-tense patients.
    de comparer le succès en termes de grossesse clinique, de fausse couche et de naissance vivante dans les deux groupes ; d'évaluer la tolérance de l’amlodipine chez des patientes normo-tendues.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Female patient ,
    • Patient scheduled for a blastocyst-type frozen embryo transfer (vitrification on D5) on cycle with hormone replacement therapy.
    • Measurement of the two uterine PIs greater than 3 (>) during the first monitoring at Dm (corresponding to D13-D16 of the cycle).
    • 18 years (≤) age (≤) 38 years.
    • BMI ≤ 30 kg / m2.
    • Carrying out a transfer test qualified as easy (passage of the cervix with a flexible or rigid catheter, without anesthesia or Pozzi forceps).
    • Collection and signature of free and informed consent.
    • Affiliation or beneficiary of a health insurance plan.
    • Sujet de sexe féminin,
    • Patiente programmée pour un transfert d’embryon congelé de type blastocyste (vitrification à J5) sur cycle avec traitement hormonal substitutif.
    • Mesure des deux IP utérins supérieure à 3 (>) lors du premier monitorage à Jm (correspondant à J13-J16 du cycle).
    • 18 ans (≤) âge (≤) 38 ans.
    • IMC ≤ 30 kg/m2.
    • Réalisation d’un test de transfert qualifié de facile (passage du col avec un cathéter souple ou rigide, sans anesthésie ni pince de Pozzi).
    • Recueil et signature du consentement libre et éclairé.
    • Affiliation ou bénéficiaire d’un régime d’assurance maladie.
    E.4Principal exclusion criteria
    • The patient actively smokes tobacco (at least one cigarette per day at the time of inclusion in the study).
    • The patient is receiving oocytes.
    • A preimplantation diagnosis is planned for this patient.
    • The patient has stage 3 or 4 endometriosis, or adenomyosis.
    • The patient has a contraindication to the use of amlodipine (recent myocardial infarction of less than one month, severe angina pectoris, severe hepatic impairment, taking ciclosporin, low blood pressure, hypersensitivity to amlodipine, dihydropyridine derivatives).
    • Concomitant intake of CYP3A4 inhibitors or enzyme inducers
    • The patient is already being treated for high blood pressure.
    • The patient has a recruited ovarian follicle (> 12mm) during the first monitoring (the most conservative case).
    • The patient is participating in another interventional study on the human person.
    • The patient is in an exclusion period determined by a previous study.
    • The patient has already participated in this study.
    • The patient is under the protection of justice, under guardianship or curatorship.
    • It is impossible to give the patient informed information.
    • It turns out to be impossible to carry out monitoring with an experienced sonographer.
    • Lactating patient according to article L1121-5 of the CSP
    • Patient protected or unable to give consent according to article L1121-8 of the Public Health Code (CSP).
    • Vulnerable person according to article L1121-6 of the CSP.
    La patiente consomme du tabac de façon active (au moins une cigarette par jour au moment de l'inclusion dans l'étude).
    • La patiente est receveuse d’ovocytes.
    • Un diagnostic préimplantatoire est prévu pour cette patiente.
    • La patiente présente une endométriose de stade 3 ou 4, ou une adénomyose.
    • La patiente présente une contre-indication à l'utilisation de l’amlodipine (infarctus du myocarde récent de moins d'un mois, angine de poitrine grave, insuffisance hépatique sévère, prise de ciclosporine, hypotension artérielle, hypersensibilité à l'amlodipine, aux dérivés de la dihydropyridine).
    • Prise concomitante d’inhibiteurs ou d’inducteurs enzymatiques du CYP3A4
    • La patiente est déjà traitée pour une hypertension artérielle.
    • La patiente a un follicule ovarien recruté (>12mm) lors du premier monitorage (cas le plus conservateur).
    • La patiente participe à une autre étude interventionnelle portant sur la personne humaine.
    • La patiente est en période d’exclusion déterminée par une étude précédente.
    • La patiente a déjà participé à cette étude.
    • La patiente est sous sauvegarde de justice, sous tutelle ou sous curatelle.
    • Il s’avère impossible de donner à la patiente des informations éclairées.
    • Il s’avère impossible de réaliser un monitorage avec un échographiste expérimenté.
    • Patiente allaitante selon l’article L1121-5 du CSP
    • Patiente protégée ou dans l’incapacité de donner son consentement selon l’article L1121-8 du Code de la Santé Public (CSP).
    • Personne vulnérable selon l’article L1121-6 du CSP.
    E.5 End points
    E.5.1Primary end point(s)
    the primary end point is the number of patients with two Pulsality index measurements (at Day m + 7 (corresponding to D20-23 of the cycle)) lower than 3 out of the number of patients having performed doppler ultrasound. This rate will be compared in the placebo group and in the amlodipine group. the measurements will be made by doppler echography
    le critère d'évaluation principal est le nombre de patients avec deux mesures d'indice de pulsalité (au jour m + 7 (correspondant à J20-23 du cycle)) inférieur à 3 sur le nombre de patients ayant effectué une échographie Doppler. Ce taux sera comparé dans le groupe placebo et dans le groupe amlodipine. les mesures seront effectuées par échographie doppler
    E.5.1.1Timepoint(s) of evaluation of this end point
    after the administration of amlodipine for 7 days
    aprés 7 jours d'administration d'amlodipine
    E.5.2Secondary end point(s)
    To meet the secondary objectives, the judgment criteria evaluated in the two groups are the ratios:
    - number of clinical pregnancies / number of transfers
    Clinical pregnancy is defined as a pregnancy diagnosed on ultrasound with at least one gestational sac. Neither an ectopic pregnancy nor an indeterminate localization pregnancy is considered to be clinical pregnancy.
    - number of miscarriages / number of transfers
    Miscarriage is defined as the loss of a clinical intrauterine pregnancy before 20 weeks of amenorrhea, confirmed by an ultrasound.
    - number of live births / number of transfers
    Live birth is defined as the birth after 20 weeks of at least one child born alive. The birth of twins or more is counted as a live birth.
    Pour répondre aux objectifs secondaires, les critères de jugements évalués dans les deux groupes sont les ratios :
    - nombre de grossesses cliniques/ nombre de transferts
    La grossesse clinique se définit comme une grossesse diagnostiquée à l'échographie avec au moins un sac gestationnel. N'est pas considérée comme grossesse clinique ni la grossesse extra-utérine, ni la grossesse de localisation indéterminée.
    - nombre de fausses couches/ nombre de transferts
    La fausse couche se définit comme la perte d'une grossesse intra-utérine clinique avant 20 semaines d'aménorrhée, confirmée par une échographie.
    - nombre de naissances vivantes/ nombre de transferts
    La naissance vivante se définit par la naissance après 20 semaines d'au moins un enfant né vivant. La naissance de jumeaux ou plus est décompté comme une naissance vivante.
    E.5.2.1Timepoint(s) of evaluation of this end point
    6 to 8 weeks after embryo transfer for the clinical pregnancy .
    20 weeks of amenorrhea for miscarriage
    6 à 8 semaines après le transfert d'embryons pour la grossesse clinique.
    20 semaines d'aménorrhée pour fausse couche
    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 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) 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 Yes
    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 Yes
    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 concerned2
    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 years3
    E.8.9.1In the Member State concerned months10
    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: 70
    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 Yes
    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 state70
    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 Decision2021-06-02
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2021-05-11
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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