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RECRUITING
NCT06177613
NA

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

Sponsor: Centre Hospitalier Universitaire de Nīmes

View on ClinicalTrials.gov

Summary

Despite technical advances in Medically Assisted Reproduction (AMP), the success of fertility treatments is sometimes limited by embryo implantation failure. The coordinated development of the embryo and the uterine endometrium requires close communication between the maternal tissue and the embryo. In in vitro fertilization (IVF), embryo transfer generally takes place between the 2nd (D2) and the 6th (D6) day following oocyte fertilization. Recent studies have shown the advantages of sequential transfer (transfer of an embryo on D2/D3 followed by the transfer of another embryo on D5/D6), with higher implantation and clinical pregnancy rate, fewer miscarriages, more live births, and yet no increase in multiple pregnancies. However, the American Society for Reproductive Medicine recommendations continue to prioritize the transfer of a single embryo for all patients aged under 38. To improve pregnancy rates for patients having a single embryo transferred, the study investigators wish to carry out on "blank" transfer, based on the principle of sequential transfer. The study investigators hypothesize that a culture medium, placed in the uterus before the time of embryo transfer, will modify immune tolerance. The study will test whether transferring the same culture medium in an equivalent quantity as during the real transfer into the uterus 2/3 days before the embryo transfer will improve tolerance to this foreign medium and, therefore, embryo implantation. The aim of this study is thus to evaluate the impact of a "blank" transfer with culture medium alone, on the results of frozen embryo transfers (FET) from IVF.

Official title: 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.

Key Details

Gender

FEMALE

Age Range

Any - Any

Study Type

INTERVENTIONAL

Enrollment

1154

Start Date

2024-02-09

Completion Date

2027-02

Last Updated

2025-02-20

Healthy Volunteers

No

Interventions

PROCEDURE

Blank culture transfer

A maximum of 0.1 ml of gassed embryo culture medium preheated to 37°C is injected into the uterine cavity transcervically using an embryo transfer catheter placed just beyond the internal os, two to 3 days before transfer of the thawed embryo

PROCEDURE

Sham transfer

An intermediate transfer step is added two or three days before the planned transfer of the frozen embryo but with an empty catheter.

Locations (7)

Hôpital Antoine Béclère

Clamart, France

Centre Hospitalier Alpes Léman

Contamine-sur-Arve, France

CHU Arnaud de Villeneuve

Montpellier, France

Clinique Saint Roch

Montpellier, France

CHU de Nîmes

Nîmes, France

Clinique Saint-Pierre

Perpignan, France

CHU de la Réunion

Saint-Pierre, Reunion