Early transfer of culture medium before embryo transfer
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.
This study is testing if putting a special fluid in the uterus before transferring frozen embryos can help women who have had trouble getting pregnant in the past.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1154 (estimated) |
| Sex | Female |
| Sponsor | Centre Hospitalier Universitaire de Nīmes Academic / other |
| Locations | 7 sites (Clamart and 6 other locations) |
| Trial ID | NCT06177613 on ClinicalTrials.gov |
What this trial studies
This study investigates the benefits of transferring a 'blank' culture medium into the uterus before the transfer of thawed embryos in patients who have previously experienced implantation failure. The aim is to enhance the communication between the embryo and the uterine lining, potentially improving the chances of successful implantation. The study will involve patients who have undergone a prior embryo transfer that did not result in pregnancy, focusing on those with frozen embryos at the D3 stage. Participants will be randomly assigned to receive either the culture medium transfer or a sham transfer.
Who should consider this trial
Good fit: Ideal candidates are women who have experienced a failed embryo transfer and have frozen embryos available for transfer.
Not a fit: Patients who have not experienced a previous embryo transfer failure or those with embryos not at the D3 stage may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve pregnancy rates for patients undergoing single embryo transfers.
How similar studies have performed: While there have been studies on sequential embryo transfers, the specific approach of early culture medium transfer is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Clamart and 6 other locations
- 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)
Study contacts
- Principal investigator: Nathalie Rougier — CHU de Nimes
- Study coordinator: Nathalie Rougier
- Email: nathalie.rougier@chu-nimes.fr
- Phone: 04.66.68.32.24
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.