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

NCT04954196 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2023-03-13

No results posted yet for this study

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 at least one of the 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.

Conditions

  • Frozen Embryo Transfer

Interventions

DRUG

Amlodipine 5mg

HRT administration: On Day 1 of the cycle, HRT is planned in accordance with the department's standard practice. * The frozen embryo transfer will be performed 6 days after progesterone initiation. * The HRT will be maintained until the pregnancy test is performed: If the test is positive,HRT will be continued for up to 12 weeks of amenorrhea at the same doses and then gradually stopped. If the test is negative,HRT will be stopped gradually Amlodipine administration: On the day of the first monitoring Dm (corresponding to D13 D16 of the cycle), a single per os dose of amlodipine 5 mg is taken at night, neither the patient nor the investigator knows what drug is the patient getting. Monitoring is systematically performed the next morning.The treatment will be maintained until the pregnancy test is performed then if the test is positive, the treatment will be maintained for a total duration of 7 weeks.

DRUG

Placebo

HRT administration: On Day 1 of the cycle, HRT is planned in accordance with the department's standard practice. * The frozen embryo transfer will be performed 6 days after progesterone initiation. * The HRT will be maintained until the pregnancy test is performed: If the test is positive, HRT will be continued for up to 12 weeks of amenorrhea at the same doses and then gradually stopped. If the test is negative, HRT will be stopped gradually Placebo administration:On the day of the first monitoring Dm (corresponding to D13-D16 of the cycle), a single per os dose of placebo (Microcrystalline cellulose) is taken at night, neither the patient nor the investigator knows what drug is the patient getting. Monitoring is systematically performed the next morning.. The treatment will be maintained until the pregnancy test is performed, then if the test is positive, the treatment will be maintained for a total duration of 7 weeks.

Sponsors & Collaborators

  • University Hospital, Montpellier

    lead OTHER

Principal Investigators

  • Noémie RANISAVLJEVIC, MD · Arnaud de Villeneuve University Hospital, Montpellier

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
38 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-08
Primary Completion
2023-10-08
Completion
2024-09-08

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04954196 on ClinicalTrials.gov