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
This trial does not accept healthy volunteersQualifiers
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 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
Trial design
Case-control
Retrospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
Implantation rate following the Day-5 ET
Implantation rate following the Day-5 ET between the case and control groups
Clinical pregnancy rate after the Day-5 ET
Clinical pregnancy rate after the Day-5 ET between the case and control groups
Ongoing PR after the day-5 ET
Ongoing PR after the day-5 ET between the case and control groups
Miscarriage rate after ET
Miscarriage rate after the Blastocyst SET in the case and the pair-matched group
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options: