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

C

Centre Hospitalier Universitaire de Nīmes

Status

Enrolling

Conditions

Single Embryo Transfer
Fertilization in Vitro

Treatments

Procedure: Sham transfer
Procedure: Blank culture transfer

Study type

Interventional

Funder types

Other

Identifiers

NCT06177613
PHRC-I/2022/NR-01

Details and patient eligibility

About

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.

Enrollment

1,154 estimated patients

Sex

Female

Ages

Under 39 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

1,154 participants in 2 patient groups

With blank culture
Experimental group
Treatment:
Procedure: Blank culture transfer
Without blank culture
Sham Comparator group
Treatment:
Procedure: Sham transfer

Trial contacts and locations

7

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Central trial contact

Nathalie Rougier

Data sourced from clinicaltrials.gov

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