Benefit of Amlodipine in HRT Cycle for Frozen Embryo Transfer in the Correction of Uterine Pulsatility Index

• Status: Not yet recruiting
• Trial end date: 2024-10-30
• Target enrollment: 0
• Participant gender: Female

Summary

Embryo implantation depends on two main factors: embryo grading quality and endometrial receptivity.Numerous tools have been suggested to evaluate these two factors. Measurement of the pulsatility index (PI) of the uterine arteries is associated with extremely low chances of pregnancy when it is high, especially higher than 3.

A pilot study of women with premature ovarian failure with uterine PIs greater than 3 showed the efficiency of nifedipine in uterine vascularization. This calcium channel blocker, used sublingually in this study, significantly lowered uterine PI in nearly half an hour.

We are therefore interested in exploring this accessible, non-invasive and inexpensive tool, in the evaluation of endometrial receptivity before an embryo transfer.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University Hospital, Montpellier
• Treatments: Amlodipine

Criteria

Inclusion Criteria:

• Female subject

• 18 years (≤) age (≤) 38 years

• Patient scheduled for a blastocyst frozen transfer (vitrification on Day 5) on HRT cycle (hormone replacement therapy)

• Measurement of the two uterine PI (pulsatility index) greater than 3 (> 3) at the first monitoring Dm (corresponding to Day 13-Day 16 of the cycle)

• BMI ≤ 30 kg / m2

• Carrying out a transfer test qualified as easy (passage through the cervix of a flexible or rigid catheter, without anesthesia or Pozzi forceps)

• Collection and signature of free and informed consent

• Subject affiliated to or beneficiary of a health insurance plan

Exclusion Criteria:

• Active smoker patient (at least one cigarette a day at the enrollment in the study)

• Oocyte recipient patient

• A pre-implantation genetic screening (PGS) is planned for the patient

• Patient with stage 3 or 4 endometriosis, or adenomyosis

• Contraindication to the use of amlodipine (recent myocardial infarction less than one month old, severe angina pectoris, severe hepatic insufficiency, treatment with ciclosporin, hypotension, hypersensitivity to amlodipine, dihydropyridine derivatives)

• Concomitant use of inhibitors or enzyme inducers of CYP3A4

• Patient already being treated for high blood pressure

• Patient with an ovarian follicle recruitmant (> 12mm) during the first monitoring (the most conservative case)

• Patient participating in another human intervention study

• Patient in the exclusion period determined by a previous study

• Patient has already participated in this study

• Patient under legal protection, guardianship or curatorship

• Impossibility to give the patient clarifying information

• Impossibility to perform monitoring by an experienced sonographer

• Breastfeeding 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