Clinical trial NCT06177613: Advantages of Early Intrauterine Transfer of "Blank" Culture Medium Prior to 1st or 2nd Transfer of Thawed Embryo(s).
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Single Embryo Transfer
Fertilization in Vitro
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2023-12-20
Enrollment: 1154
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


Eligibility 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

Primary outcomes:
measure: Clinically progressive pregnancy rate between groups
timeFrame: 12 weeks of amenorrhea
Secondary outcomes:
measure: Occurrence of pregnancy between groups
timeFrame: Day 14
measure: Occurrence of a biochemical pregnancy between groups
timeFrame: Day 14
measure: Occurrence of a clinical pregnancy between groups
timeFrame: 6 weeks of amenorrhea
measure: Occurrence of an early miscarriage between groups
timeFrame: 12 weeks of amenorrhea
measure: Occurrence of live birth
timeFrame: Upon giving birth (maximum month 9)
measure: Differential cost-result ratio
timeFrame: End of study (Year 3)
measure: Total estimated expenditure for the two care strategies compared (budget impact analysis) over a one-year time horizon.
timeFrame: End of study (Year 3)
Other outcomes:
Locations:
city: Clamart
country: France
facility: Hôpital Antoine Béclère
city: Contamine-sur-Arve
country: France
facility: Centre Hospitalier Alpes Léman
city: Montpellier
country: France
facility: CHU Arnaud de Villeneuve
city: Montpellier
country: France
facility: Clinique Saint Roch
city: Nîmes
country: France
facility: CHU de Nîmes
city: Perpignan
country: France
facility: Clinique Saint-Pierre
city: Saint-Pierre
country: Réunion
facility: CHU de la Réunion
Study officials:
affiliation: CHU de Nimes
name: Nathalie Rougier
role: PRINCIPAL_INVESTIGATOR
References: