Actively Recruiting
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
Eligibility Criteria
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
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
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
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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