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

NCT06177613 | Recruiting

• 1 other identifier: PHRC-I/2022/NR-01
• Study Type: interventional
• Target: 1,154
• Locations: 2 countries
• Sites: 7

Brief 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.

Conditions

Single Embryo Transfer; Fertilization in Vitro

Outcome Measures

Primary Outcomes (1)

• Clinically progressive pregnancy rate between groups

  Measured on first-trimester ultrasound

  12 weeks of amenorrhea

Secondary Outcomes (7)

• Occurrence of pregnancy between groups

  Day 14

• Occurrence of a biochemical pregnancy between groups

  Day 14

• Occurrence of a clinical pregnancy between groups

  6 weeks of amenorrhea

• Occurrence of an early miscarriage between groups

  12 weeks of amenorrhea

• Occurrence of live birth

  Upon giving birth (maximum month 9)

Study Arms (2)

With blank culture

EXPERIMENTAL

Procedure: Blank culture transfer

Without blank culture

SHAM COMPARATOR

Procedure: Sham transfer

Interventions

Blank culture transfer PROCEDURE

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

With blank culture

Sham transfer PROCEDURE

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

Without blank culture

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Having had a first "fresh" or frozen embryo transfer, whatever the embryo's stage of development, transfer followed by pregnancy failure ;
• Frozen embryos must be at least D3 stage;
• The patient must have given their free and informed consent and signed the consent form
• The patient must be a member or beneficiary of a health insurance plan

You may not qualify if:

• The patient is under safeguard of justice or state guardianship

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (7)

Hôpital Antoine Béclère

Clamart, France

NOT YET RECRUITING

Centre Hospitalier Alpes Léman

Contamine-sur-Arve, France

NOT YET RECRUITING

CHU Arnaud de Villeneuve

Montpellier, France

NOT YET RECRUITING

Clinique Saint Roch

Montpellier, France

NOT YET RECRUITING

CHU de Nîmes

Nîmes, 30029, France

RECRUITING

Clinique Saint-Pierre

Perpignan, France

NOT YET RECRUITING

CHU de la Réunion

Saint-Pierre, Reunion

NOT YET RECRUITING

Study Officials

• Nathalie Rougier

  CHU de Nimes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nathalie Rougier

CONTACT

04.66.68.32.24; nathalie.rougier@chu-nimes.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: December 20, 2023
• Study Start: February 9, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: February 20, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

RE (1); FR (6)