uterine arteries pulsalility index for patients awaiting frozen embryo transfer
Conditions
Interventions
Trade Name: AMLODIPINE
Pharmaceutical Form: Capsule
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Sponsors
University hospital of Montpellier
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 70 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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). ;Secondary Objective: 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.;Primary 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 ;Timepoint(s) of evaluation of this end point: after the administration of amlodipine for 7 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary 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.;Timepoint(s) of evaluation of this end point: 6 to 8 weeks after embryo transfer for the clinical pregnancy . 20 weeks of amenorrhea for miscarriage | — |
Countries
France
Contacts
Public ContactANNE CADENE
University hospital of Montpellier
Outcome results
None listed