Impact of Uterine Immune Profiling and Personalized Treatments in Patients Receiving a Single Blastocyst: a Matched Controlled Study

Not yet recruiting

• Conditions: Infertility; Success Rate of Assisted Reproductive Therapy; Single Embryo Transfer; Pregnancy Outcomes; Immunological Tolerance; Immune System
• Interventions: Combination Product: Personalized care in function of the immune profile

• Registration Number: NCT06503952
• Lead Sponsor: Matricelab Innove

Brief Summary

A recent randomised controlled trial and previous large cohort studies have shown that the uterine immune environment is a crucial element in improving the performance of Assisted Reproductive therapy (ART). As previous studies mixed Day-3, Day-5, single or doble embryo transfer, the clear influence of the endometrial environment on the embryo itself and its type of transfer (fresh or freeze thawed) need further investigation.

To complement previous studies, the present matched- pair study aims to select the population who exclusively received a single Day-5 embryo transfer (SET) and benefitted of a uterine immune profiling between 1 January 2020 and 30 June 2023 before the SET Day-5.

This population will be matched to a population. who did not have uterine immune profiling in the nine months prior to the single Day 5 embryo transfer between 2018 and 2023.

The matching criteria are the maternal age (+/-1 year), the past history of ART (same number of previous oocytes pick-up, same number of previous embryo transfer) and the same type of transfer (IVF, ICSI, frozen transfer) and the same category of expansion of the blastocoel (B1-B2/ B3-B4/ B5-B6).

The primary end-point is the live birth rate (LBR) following the Day 5 SET in the population who benefited from pre-SET immune profiling versus the LBR following the Day 5 SET in the pair- matched population who did not benefit from pre-SET uterine immune profiling Secondary end point are the clinical pregnancy rate and miscarriage rate per SET in the two paired populations

Detailed Description

The PRECONCEPTIO software will be used to extract all the uterine immune profiles carried out between January 2020 and June 2023 for patients attending the two reproductive centres, Bluets and Diaconnesse.

In parallel, data will be extracted from the MEDIFIRST software selecting all patients who benefited from a single day 5 embryo transfer between January 2018 and March 2024.

The case group represents the selection of patients who had both uterine immune profiling prior to ET and Day 5 single embryo transfer within the nine months following uterine immune profiling.

Each patient in the treated group is matched to patients who had a single Day 5 ET without immune profiling in the nine months prior to ET.

Matching criteria will be maternal age (+/-1year) and, number of previous egg retrievals (including the ones without any transfer) and, number of previous ETs and technique used (IVF, ICSI, frozen embryo transfer) and degree of expansion of blastocoel (B1-B2/B3-B4/B5-B6) to reflect the quality of the embryo transferred The primary end-point is the live birth rate (LBR) following the Day 5 SET in the population who benefited from pre-SET immune profiling versus the LBR following the Day 5 SET in the pair- matched population who did not benefit from pre-SET uterine immune profiling Secondary end point are the clinical pregnancy rate and miscarriage rate per SET in the two paired populations

Impact of the uterine immune profiling on the live birth rate

* In function of the type of embryo transfer (fresh or freezed thawed)

* In function of the quality of the blastocyst transferred

* In function of the range of embryo transfer

Study Timeline

• Study First Submitted: 2024-07-10
• Study First Submitted QC: 2024-07-10
• Study First Posted: 2024-07-16
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-20
• Last Update Posted: 2024-12-27
• Study Start: 2025-01-15
• Primary Completion: 2025-04-30
• Study Completion: 2025-05-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 340

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
case group	Personalized care in function of the immune profile	Case group: Group with uterine immune profiling before the Day-5 ET

Primary Outcome Measures

Name	Time	Method
Live birth rate following the single Day-5 embryo transfer (ET)	9 months after the ET	Live birth rate following the Day-5 ET between the case and control groups

Secondary Outcome Measures

Name	Time	Method
Implantation rate following the Day-5 ET	one month after ET	Implantation rate following the Day-5 ET between the case and control groups
Clinical pregnancy rate after the Day-5 ET	two weeks after ET	Clinical pregnancy rate after the Day-5 ET between the case and control groups
Ongoing PR after the day-5 ET	12 weeks after ET	Ongoing PR after the day-5 ET between the case and control groups
Miscarriage rate after ET	20 weeks after the ET	Miscarriage rate after the Blastocyst SET in the case and the pair-matched group

Trial Locations

Locations (2)

Hopital des diaconnesse- Centre d'assistance medicale a la procreation; 🇫🇷 Paris, ile de France, France

Hopital des Bluets- centre d'assistance medicale à la procreation; 🇫🇷 Paris, Ile de, France