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

NCT06503952 | Not Yet Recruiting

• 1 other identifier: MatriceLab Innove
• Study Type: observational
• Target: 340
• Locations: 1 country
• Sites: 2

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

Conditions

Infertility; Success Rate of Assisted Reproductive Therapy; Single Embryo Transfer; Pregnancy Outcomes; Immunological Tolerance; Immune System

Keywords

infertility; success rate of assisted reproductibve therapy; Single embryo transfer; uterine immune profiling; personalized care; Live birth rate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Implantation rate following the Day-5 ET

  one month after ET

• Clinical pregnancy rate after the Day-5 ET

  two weeks after ET

• Ongoing PR after the day-5 ET

  12 weeks after ET

• Miscarriage rate after ET

  20 weeks after the ET

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 41 Years
• Gender Eligibility Details: Female involved in IVF
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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

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).

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Matricelab Innove: lead

Study Sites (2)

Hopital des Bluets- centre d'assistance medicale à la procreation

Paris, Ile de, 75012, France

Location

Hopital des diaconnesse- Centre d'assistance medicale a la procreation

Paris, Île-de-France Region, 75012, France

Location

Related Links

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

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Central Study Contacts

Nathalie Lédée, MD, PhD

CONTACT

33681560394; nathalie.ledee@matricelabinnove.com

Nathalie LEDEE, MD, PhD

CONTACT

+33681560394; nathalie.ledee@matricelabinnove.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: July 10, 2024
• First Posted: July 16, 2024
• Study Start: January 15, 2025
• Primary Completion: April 30, 2025
• Study Completion: May 30, 2025
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)