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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorCentre Hospitalier Universitaire de Nīmes

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Blank culture transfer

    Procedure/Surgery

    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

    Procedure/Surgery

    An intermediate transfer step is added two or three days before the planned transfer of the frozen embryo but with an empty catheter.

Treatment groups

1,154 Participants
are divided into 2 treatment groups
Group A: With blank cultureExperimental treatment 1 intervention
Group B: Without blank cultureSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Clinically progressive pregnancy rate between groups

Measured on first-trimester ultrasound

Time frame
12 weeks of amenorrhea

Secondary outcomes

1

Occurrence of pregnancy between groups

Defined by a positive beta HCG test ≥ 100 IU/ml

Time frame
Day 14
2

Occurrence of a biochemical pregnancy between groups

Defined by a positive beta HCG test ≥ 10 IU/ml and \< 100 IU/ml

Time frame
Day 14
3

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

Time frame
6 weeks of amenorrhea
4

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

Time frame
12 weeks of amenorrhea

Other outcomes

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