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NCT Number: NCT06177613

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

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.

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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Antoine Béclère, Clamart, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blank culture transfer

Procedure

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

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

Primary outcomes

  1. Clinically progressive pregnancy rate between groups

    Time frame: 12 weeks of amenorrhea

    Measured on first-trimester ultrasound

Secondary outcomes

  1. Occurrence of pregnancy between groups

    Time frame: Day 14

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

  2. Occurrence of a biochemical pregnancy between groups

    Time frame: Day 14

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

  3. Occurrence of a clinical pregnancy between groups

    Time frame: 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

  4. Occurrence of an early miscarriage between groups

    Time frame: 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

  5. Occurrence of live birth

    Time frame: Upon giving birth (maximum month 9)

    Yes/no

  6. Differential cost-result ratio

    Time frame: 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.

  7. Total estimated expenditure for the two care strategies compared (budget impact analysis) over a one-year time horizon.

    Time frame: End of study (Year 3)

    Calculated at national level (implementation of the system and consumption of care)

Study contacts

Contact information is provided by the study sponsor or research team.

Nathalie Rougier

CONTACT

[email protected]

04.66.68.32.24

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study 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.

Acronym: TRABLAN

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Dec 20, 2023
Registry last updated
Feb 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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