About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Blank culture transfer
Procedure/SurgeryA 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
Procedure/SurgeryAn intermediate transfer step is added two or three days before the planned transfer of the frozen embryo but with an empty catheter.
Treatment groups
Trial outcomes
Primary outcomes
Clinically progressive pregnancy rate between groups
Measured on first-trimester ultrasound
Secondary outcomes
Occurrence of pregnancy between groups
Defined by a positive beta HCG test ≥ 100 IU/ml
Occurrence of a biochemical pregnancy between groups
Defined by a positive beta HCG test ≥ 10 IU/ml and \< 100 IU/ml
Occurrence of a clinical pregnancy between groups
Defined by a positive beta HCG test ≥ 100 IU/ml and presence of at least one gestational sac on dating ultrasound
Occurrence of an early miscarriage between groups
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
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