Immune Profile Analysis and Biomarker Identification in Women With Repeated Implantation Failure or Unexplained Recurrent Spontaneous Miscarriage

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-39
SponsorCentre Hospitalier Universitaire, Amiens

About this trial

Implantation is a determining step in human reproduction which requires the transition from a pro-inflammatory state to an anti-inflammatory state allowing the implantation of a competent embryo within a receptive endometrium, and then the maternal immunotolerance towards the alloantigenic fetus. Repeat implantation failures (RIFs), that refers to the fail to achieve a clinical pregnancy after the transfer of at least 3-4 good quality embryos or two blastocysts, and unexplained recurrent spontaneous miscarriage (RM) (≥2-3) could be related in some patients to immune imbalances characterized by an excessive and prolonged inflammatory response and/or a defect of anti-inflammatory regulation. In this context, several therapies have been evaluated in patients with RIFs or RMs in order to restore the immune balance, with heterogeneous results. No serum biomarker assay has been routinely approved to identify patients with immune imbalances that may explain repeated pregnancy failures and to predict the success of the subsequent IVF/ICSI cycle. The immunological analysis on peripheral blood will be based on the determination of the proportions of immune subpopulations (e.g. CD4+ et CD8+, TH1, TH2, TH17, Treg, ILC 1, ILC2, and ILC3) on the one hand and the circulating level of plasma cytokines on the other hand.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Women aged 18 to 39 years

women with a history of RIF or unexplained RM

women with a negative diagnostic work-up (including pelvic ultrasound and hysteroscopy, parental karyotype, thyroid function test, and anti-thyroid and anti-phospholipid antibodies)

women with a basal FSH level <10IU/l and AMH level >1.5ng/ml

Disqualifiers

Ongoing pelvic and/or systemic infection

Chronic infectious endometritis

Active neoplasia

Autoimmune and autoinflammatory disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • blood sample

    Biological/Vaccine

    Blood sampling by venipuncture will be performed : * for patients and controls: between the 20th and 24th day of the menstrual cycle (implantation window) preceding the following IVF+/-ICSI cycle * for patients receiving an endometrial biopsy: on the same day as the endometrial biopsy * for patients and controls receiving follicular stimulation for ovarian puncture: the day of the oocyte puncture * for patients and controls undergoing embryo transfer: on the day of embryo implantation

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: patientsExperimental treatment 1 intervention
Group B: controlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Variation of the proportion of CD4+ subpopulations between both patient groups

Time frame
18 months
2

Variation of the proportion of CD8+ subpopulations between both patient groups

Time frame
18 months
3

Variation of the proportion of TH1 subpopulations between both patient groups

Time frame
18 months
4

Variation of the proportion of TH2 subpopulations between both patient groups

Time frame
18 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.