Benefit of Early Intrauterine Transfer of "Blank" Culture Medium Prior to Transfer of a Thawed Embryo From 1st in Vitro Fertilization

Fertilization in Vitro Clinical Trial

— TRABLAN  

Official title:

Benefit of Early Intrauterine Transfer of "Blank" Culture Medium Prior to Transfer of a Thawed Embryo From 1st in Vitro Fertilization - Randomized, Single-blind, Multicenter Controlled Trial.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06177613
• Other study ID #: PHRC-I/2022/NR-01
• Status: Recruiting
• Phase: N/A
• Start date: February 9, 2024
• Est. completion date: February 2027

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: Nathalie Rougier
• Phone: 04.66.68.32.24
• Email: nathalie.rougier[@]chu-nimes.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1154
• Est. completion date: February 2027
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 39 Years

Eligibility

Inclusion Criteria:

• Having had a first "fresh" or frozen embryo transfer, whatever the embryo's stage of development, transfer followed by pregnancy failure ;
• Having at least two embryos eligible for transfer or freezing during a 1st IVF attempt (one fresh + one frozen or two frozen);
• 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

Related Conditions & MeSH terms

• Fertilization in Vitro
• Single Embryo Transfer

Intervention

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

Locations

Country	Name	City	State
France	Hôpital Antoine Béclère	Clamart
France	Centre Hospitalier Alpes Léman	Contamine-sur-Arve
France	CHU Arnaud de Villeneuve	Montpellier
France	CHU de Nîmes	Nîmes
France	Clinique Saint-Pierre	Perpignan
Réunion	CHU de la Réunion	Saint-Pierre

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Countries where clinical trial is conducted

France,  Réunion, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinically progressive pregnancy rate between groups	Measured on first-trimester ultrasound	12 weeks of amenorrhea
Secondary	Occurrence of pregnancy between groups	Defined by a positive beta HCG test = 100 IU/ml	Day 14
Secondary	Occurrence of a biochemical pregnancy between groups	Defined by a positive beta HCG test = 10 IU/ml and < 100 IU/ml	Day 14
Secondary	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	6 weeks of amenorrhea
Secondary	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	12 weeks of amenorrhea
Secondary	Occurrence of live birth	Yes/no	Upon giving birth (maximum month 9)
Secondary	Differential cost-result ratio	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.	End of study (Year 3)
Secondary	Total estimated expenditure for the two care strategies compared (budget impact analysis) over a one-year time horizon.	Calculated at national level (implementation of the system and consumption of care)	End of study (Year 3)