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

Not Applicable

Recruiting

• Conditions: Single Embryo Transfer; Fertilization in Vitro
• Interventions: Procedure: Sham transfer; Procedure: Blank culture transfer

• Registration Number: NCT06177613
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-11
• Study First Submitted QC: 2023-12-11
• Study First Posted: 2023-12-20
• Study Start: 2024-02-09
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-19
• Last Update Posted: 2025-02-20
• Primary Completion: 2026-05
• Study Completion: 2027-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1154

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Without blank culture	Sham transfer	-
With blank culture	Blank culture transfer	-

Primary Outcome Measures

Name	Time	Method
Clinically progressive pregnancy rate between groups	12 weeks of amenorrhea	Measured on first-trimester ultrasound

Secondary Outcome Measures

Name	Time	Method
Occurrence of a biochemical pregnancy between groups	Day 14	Defined by a positive beta HCG test ≥ 10 IU/ml and \< 100 IU/ml
Occurrence of a clinical pregnancy between groups	6 weeks of amenorrhea	Defined by a positive beta HCG test ≥ 100 IU/ml and presence of at least one gestational sac on dating ultrasound
Occurrence of pregnancy between groups	Day 14	Defined by a positive beta HCG test ≥ 100 IU/ml
Total estimated expenditure for the two care strategies compared (budget impact analysis) over a one-year time horizon.	End of study (Year 3)	Calculated at national level (implementation of the system and consumption of care)
Differential cost-result ratio	End of study (Year 3)	Ratio of the cost differential and the number of additional live births (additional progressive clinical pregnancies) between the two strategies, to evaluate the cost per additional live birth.
Occurrence of an early miscarriage between groups	12 weeks of amenorrhea	Defined by the presence of a pregnancy defined by a positive beta HCG test ≥ 100 IU at D14 and the absence of an evolving clinical pregnancy at first-trimester ultrasound
Occurrence of live birth	Upon giving birth (maximum month 9)	Yes/no

Trial Locations

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, Réunion