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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date June 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
Health authority
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

Study Design


Related Conditions & MeSH terms


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 Clinique Saint Roch 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)
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