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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06503952
Acronym
UTIMPROSET
Enrollment
340
Registered
2024-07-16
Start date
2025-01-15
Completion date
2025-05-30
Last updated
2024-12-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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

Interventions

None listed

Sponsors

Matricelab Innove
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 41 Years
Healthy volunteers
No

Inclusion criteria

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).

Design outcomes

Primary

MeasureTime frameDescription
Live birth rate following the single Day-5 embryo transfer (ET)9 months after the ETLive birth rate following the Day-5 ET between the case and control groups

Secondary

MeasureTime frameDescription
Implantation rate following the Day-5 ETone month after ETImplantation rate following the Day-5 ET between the case and control groups
Clinical pregnancy rate after the Day-5 ETtwo weeks after ETClinical pregnancy rate after the Day-5 ET between the case and control groups
Ongoing PR after the day-5 ET12 weeks after ETOngoing PR after the day-5 ET between the case and control groups
Miscarriage rate after ET20 weeks after the ETMiscarriage rate after the Blastocyst SET in the case and the pair-matched group

Countries

France

Contacts

Primary ContactNathalie Lédée, MD, PhD
nathalie.ledee@matricelabinnove.com33681560394
Backup ContactNathalie LEDEE, MD, PhD
nathalie.ledee@matricelabinnove.fr+33681560394

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026