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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Infertility; Immune System; Pregnancy Outcomes; Single Embryo Transfer; Immunological Tolerance; Success Rate of Assisted Reproductive Therapy
• Intervention / Treatment: Combination product: Personalized care in function of the immune profile

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 Type: Observational
• Enrollment (Estimated): 340

Contacts and Locations

• Study Contact: Name: Nathalie Lédée, MD, PhD; Phone Number: 33681560394; Email: nathalie.ledee@matricelabinnove.com
• Study Contact Backup: Name: Nathalie LEDEE, MD, PhD; Phone Number: +33681560394; Email: nathalie.ledee@matricelabinnove.fr

Study Locations

• France
  • Ile de
    • Paris, Ile de, France, 75012
      • Hopital des Bluets- centre d'assistance medicale à la procreation
      • Contact: Nathalie Lédée, MD, PhD; Phone Number: 33681560394; Email: nathalie-ledee@orange.fr
      • Contact: Laura Prat-Ellenberg, MD; Phone Number: +330669580724; Email: laura.prat-ellenberg@bluets.org
      • Contact: Nathalie Ledee, MD PHD
  • ile de France
    • Paris, ile de France, France, 75012
      • Hopital des diaconnesse- Centre d'assistance medicale a la procreation
      • Contact: Gwenola KEROMNES, MD; Phone Number: +33662106322; Email: gkeromnes@hopital-dcss.org
      • Contact: Gwenola Keromnes, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with a single embryo transfer at Day-5 case group: With an immune profile within the nine month before ET Control group: without immune profiling performed

Description

For case: Uterine immune profiling followed by a Day-5 fresh SET or day-5 or Day-6 freeze-thawed SET within the nine months following the uterine immune profiling between January 2020 and June 2023.

Will be excluded patients with no SET day-5, with uterine immune profiling more than nine months before, or with no matching pair For control: Blastocyst SET without uterine immune profiling within the year prior the embryo transfer matched to the case group between January 2018 on June 2023

• maternal age (+/-1 year) and
• 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).

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
case group; Case group: All the patients who would have benefitted (with informed consent) of a uterine immune profile and a fresh Day-5 SET or a day-5 or-6 SET between January 2020 and march 2024 would be enrolled
control group; Pair-matched group: Group without uterine immune profile before the SET 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Live birth rate following the single Day-5 embryo transfer (ET)	Live birth rate following the Day-5 ET between the case and control groups	9 months after the ET

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Matricelab Innove

Publications and helpful links

Helpful Links

• review on uterine immune profiling
• cohort study on uterine immune profiling

Study record dates

Study Major Dates

• Study Start (Estimated): January 15, 2025
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): May 30, 2025

Study Registration Dates

• First Submitted: July 10, 2024
• First Submitted That Met QC Criteria: July 10, 2024
• First Posted (Actual): July 16, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 20, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: infertility; Live birth rate; Single embryo transfer; personalized care; success rate of assisted reproductibve therapy; uterine immune profiling
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Infertility
• Other Study ID Numbers: MatriceLab Innove

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No