An interventional study of blood sample in Repeated Embryo Implantation Failure, Recurrent Miscarriage and Immune System, sponsored by Centre Hospitalier Universitaire, Amiens. Recruiting at 1 site in France. Open to female participants aged 18 Years to 39 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-11.
Sponsored by Centre Hospitalier Universitaire, Amiens · Not applicable, Interventional, and Other
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.
102 studies on the registry are indexed under Abortion, Habitual; 21 are open to participants now.
This study's planned enrollment of 150 is above the median of 126 across 55 interventional studies indexed under Abortion, Habitual.
Browse Abortion, Habitual studies →Centre Hospitalier Universitaire, Amiens is the lead sponsor of 586 studies on the registry; 185 are open to participants now.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
* Women aged 18 to 39 years * with a history of RIF or unexplained RM * with a negative diagnostic work-up (including pelvic ultrasound and hysteroscopy, parental karyotype, thyroid function test, and anti-thyroid and anti-phospholipid antibodies) * with a basal FSH level \<10IU/l and AMH level \>1.5ng/ml * with a regular menstrual cycle of 30+/-5 days * receiving a new cycle of in vitro fertilization (IVF) +/- intracytoplasmic sperm injection (ICSI) for patients in the RIF group or a first cycle of IVF +/-ICSI for patients in the RM group * received written and oral information and signed an informed consent
Biological: blood sample
* Controls recruited in the Obstetrics and Gynecology Department with at least one live birth after a spontaneous pregnancy (with a time to conception of less than 12 months for each pregnancy) Voluntary oocyte donors recruited within the CECOS de Picardie (having presented at least one live birth with a delay necessary to conceive of less than 12 months) * Controls recruited in the Reproductive Medicine and Biology Department having presented at least one live birth (spontaneous with a delay to conceive of less than 12 months for each pregnancy or after one or two MPA procedures) and benefiting from an IVF+/-ICSI procedure for secondary infertility * Controls recruited in the department of Medicine and Reproductive Biology with a normal infertility assessment and benefiting from an IVF procedure with ICSI on male indication.
Biological: 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
Variation of the proportion of CD4+ subpopulations between both patient groups
Time frame: 18 months
Variation of the proportion of CD8+ subpopulations between both patient groups
Time frame: 18 months
Variation of the proportion of TH1 subpopulations between both patient groups
Time frame: 18 months
Variation of the proportion of TH2 subpopulations between both patient groups
Time frame: 18 months
Variation of the proportion of TH17 subpopulations between both patient groups
Time frame: 18 months
Variation of the proportion of Treg subpopulations between both patient groups
Time frame: 18 months
Variation of the proportion of ILC 1 subpopulations between both patient groups
Time frame: 18 months
Variation of the proportion of ILC 2 subpopulations between both patient groups
Time frame: 18 months
Variation of the proportion of ILC 3 subpopulations between both patient groups
Time frame: 18 months
Variation of the proportion of TNFα concentrations between both patient groups
Time frame: 18 months
Variation of the proportion of IFN gamma concentrations between both patient groups
Time frame: 18 months
Variation of the proportion of TGF-β concentrations between both patient groups
Time frame: 18 months
Variation of the proportion of IL-10 concentrations between both patient groups
Time frame: 18 months
Variation of the proportion of IL-17 concentrations between both patient groups
Time frame: 18 months
Plan to share: No
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Started Aug 2024 (actual). Primary completion is estimated for Aug 2026, 24 months after the start.
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