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Recruiting Not applicable

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

NCT06177613 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2024-02-09
Last updated
2025-02-20

Condition(s) studied

Single Embryo TransferFertilization in Vitro

Investigational drug(s) / intervention(s)

Blank culture transferSham transfer

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

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.

Study 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.

Eligibility

Sex
FEMALE
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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 Exclusion Criteria: * The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study * The patient is under safeguard of justice or state guardianship

Primary outcome measure(s)

  • Clinically progressive pregnancy rate between groups — 12 weeks of amenorrhea
    Measured on first-trimester ultrasound

Trial sites (7)

FacilityCityRegionStatus
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 France Recruiting
Clinique Saint-Pierre Perpignan France Not Yet Recruiting
CHU de la Réunion Saint-Pierre Reunion Not Yet Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06177613 on ClinicalTrials.gov ↗ ← All trials in France