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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-41
SponsorMatricelab Innove

About this trial

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

Eligibility criteria

Qualifiers

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).

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

340 Participants
are grouped into 2 trial groups

Sponsors and collaborators