Recurrent Pregnancy Loss Clinical Trial
Official title:
Use of Metabolomics for the Identification of Endometrial Biomarkers for Recurrent Pregnancy Loss and Reccurent Implantation Failure Following in Vitro Fertilization.
It is a case-control study composed of 3 groups : 2 cases groups (RIF and IRPL) already
composed as part of a pre-existing research project and 1 control group including patients
undergoing ART for male factor infertility.
The purpose of this study is to compare the 2 case group with the control group to identify
metabolomics signatures.
The investigators have designed a unicentric, case-control, retro- and prospective study to
compare the endometrial metabolomics profile in three groups of patients. The two case groups
(RIF and IRPL) are already composed and the endometrial and blood samples already taken as
part of a pre-existing research project. The current protocol concerns the control group that
includes patients undergoing ART for male factor infertility.
The study will include three groups. The first group is composed of patients with a history
of RIF following IVF-ET. RIF is defined as failure to obtain a clinical pregnancy (fetal
cardiac activity at 6-7 weeks gestational age (GA)) following at least 3 different transfers
of at least 4 good quality embryos (fresh or frozen).
The second group comprises patients with a history of IRPL, defined as three or more
consecutive pregnancy losses that occurred before 14 weeks gestational age. Early pregnancy
losses diagnosed before ultrasonographic confirmation will be included.
The third group will include patients undergoing ART for male factor infertility.
The study protocol will be presented and explained to all eligible patients in the control
group during the routine consultation before treatment. Patients who agree to participate
will contact the department to program the inclusion visit with one of the attending
physicians in the department, during which the blood and endometrial samples will be taken.
The inclusion visit will take place at the department of reproductive medicine of Angers
University Hospital around day 21 of the menstrual cycle (in the middle of the implantation
window, which occurs between day 19 and 23 of the cycle, day 1 being the first menstruation
day).
The metabolomics analysis will be performed according to the same protocol for all samples
(study and control groups)
;
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|---|---|---|---|
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