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

Condition(s) studied

Investigational drug(s) / intervention(s)

blood sample: 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

Study summary

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

Primary outcome measure(s)

• Variation of the proportion of CD4+ subpopulations between both patient groups — 18 months
• Variation of the proportion of CD8+ subpopulations between both patient groups — 18 months
• Variation of the proportion of TH1 subpopulations between both patient groups — 18 months
• Variation of the proportion of TH2 subpopulations between both patient groups — 18 months
• Variation of the proportion of TH17 subpopulations between both patient groups — 18 months
• Variation of the proportion of Treg subpopulations between both patient groups — 18 months
• Variation of the proportion of ILC 1 subpopulations between both patient groups — 18 months
• Variation of the proportion of ILC 2 subpopulations between both patient groups — 18 months
• Variation of the proportion of ILC 3 subpopulations between both patient groups — 18 months
• Variation of the proportion of TNFα concentrations between both patient groups — 18 months
• Variation of the proportion of IFN gamma concentrations between both patient groups — 18 months
• Variation of the proportion of TGF-β concentrations between both patient groups — 18 months
• Variation of the proportion of IL-10 concentrations between both patient groups — 18 months
• Variation of the proportion of IL-17 concentrations between both patient groups — 18 months

Trial sites (1)

More Centre Hospitalier Universitaire, Amiens trials in France