Actively Recruiting

Phase Not Applicable
FEMALE
ID06177613

Advantages of Early Intrauterine Transfer of "Blank" Culture Medium Prior to 1st or 2nd Transfer of Thawed Embryo(s). Randomized, Single-blind, Multicenter Controlled Trial.

Led by Centre Hospitalier Universitaire de Nīmes · Updated on 2025-02-20

1154

Participants Needed

7

Research Sites

39 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to improve pregnancy success rates in women undergoing frozen embryo transfers (FET) after in vitro fertilization (IVF). It evaluates whether placing a "blank" culture medium into the uterus a few days before the embryo transfer can enhance immune tolerance and support embryo implantation. The study compares this approach to a sham transfer procedure without the culture medium, focusing on women who have experienced previous embryo transfer failures. Participants are randomly assigned to one of two groups: the experimental group receives a small amount of warmed embryo culture medium injected into the uterine cavity two to three days before the frozen embryo transfer, while the control group undergoes a sham transfer with an empty catheter during the same timeframe. The study is single-blind and involves multiple centers. During the trial, researchers will monitor pregnancy outcomes, including early pregnancy occurrence, biochemical and clinical pregnancy rates at various time points, early miscarriage rates, and live birth rates. They will also assess cost-effectiveness between the two care strategies. Participant involvement includes consent, membership in a health insurance plan, and follow-up evaluations up to and beyond the pregnancy period, with the primary outcome measured at 12 weeks of amenorrhea.

CONDITIONS

Brief Title

Advantages of Early Intrauterine Transfer of "Blank" Culture Medium Prior to 1st or 2nd Transfer of Thawed Embryo(s).

Who Can Participate

FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Having had a first "fresh" or frozen embryo transfer followed by pregnancy failure
  • Frozen embryos must be at least at the 3-day (D3) stage
  • The patient must have given free and informed consent and signed the consent form
  • The patient must be a member or beneficiary of a health insurance plan
Not Eligible

You will not qualify if you...

  • Participating in an interventional study or within an exclusion period from a previous study
  • Under safeguard of justice or state guardianship

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Single procedure occurring 2 to 3 days before embryo transfer

Participants receive either an early intrauterine transfer of blank culture medium or a sham transfer two to three days before the first or second transfer of thawed embryos.

1 visit (in-person)

Follow-up

Duration - Up to 9 months until giving birth

Participants are monitored for pregnancy outcomes including biochemical, clinical, and live birth rates.

Visits at Day 14, 6 weeks, 12 weeks of amenorrhea, and upon giving birth

Trial Site Locations

Total: 7 locations

1

Hôpital Antoine Béclère

Clamart, France

Not Yet Recruiting

2

Centre Hospitalier Alpes Léman

Contamine-sur-Arve, France

Not Yet Recruiting

3

CHU Arnaud de Villeneuve

Montpellier, France

Not Yet Recruiting

4

Clinique Saint Roch

Montpellier, France

Not Yet Recruiting

5

CHU de Nîmes

Nîmes, France, 30029

Actively Recruiting

6

Clinique Saint-Pierre

Perpignan, France

Not Yet Recruiting

7

CHU de la Réunion

Saint-Pierre, Reunion

Not Yet Recruiting

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Research Team

N

Nathalie Rougier

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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