Impact of Uterine Immune Profiling and Personalized Treatments in Patients Receiving a Single Blastocyst: a Matched Controlled Study
NCT ID: NCT06503952
Last Updated: 2024-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
340 participants
OBSERVATIONAL
2025-01-15
2025-05-30
Brief Summary
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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
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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
Conditions
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Keywords
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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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
No interventions assigned to this group
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
No interventions assigned to this group
Eligibility Criteria
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Exclusion Criteria
* 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).
18 Years
41 Years
FEMALE
No
Sponsors
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Matricelab Innove
OTHER
Responsible Party
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Dr Nathalie Lédée
MD, PhD
Locations
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Hopital des Bluets- centre d'assistance medicale à la procreation
Paris, Ile de, France
Hopital des diaconnesse- Centre d'assistance medicale a la procreation
Paris, Île-de-France Region, France
Countries
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Central Contacts
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Facility Contacts
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Nathalie Lédée, MD, PhD
Role: primary
Laura Prat-Ellenberg, MD
Role: backup
Nathalie Ledee, MD PHD
Role: backup
Gwenola KEROMNES, MD
Role: primary
Gwenola Keromnes, MD
Role: backup
Related Links
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review on uterine immune profiling
cohort study on uterine immune profiling
Other Identifiers
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MatriceLab Innove
Identifier Type: -
Identifier Source: org_study_id