Immune profiling to identify biomarkers in women with repeated implantation failure or unexplained recurrent miscarriage

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study analyzes immune-related biomarkers in blood to identify patterns associated with repeated implantation failure or unexplained recurrent miscarriage. Participants are women aged 18–39 undergoing a new IVF/ICSI cycle for RIF or in RM groups, with a negative diagnostic work-up and adequate ovarian reserve. Blood samples are collected to perform immunological analyses that may reveal markers linked to impaired maternal tolerance of the embryo. The goal is to identify serum biomarkers that could guide future personalized approaches. The study is conducted at a single center in Amiens, France, led by Centre Hospitalier Universitaire d'Amiens.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* For patients :
* 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
* women with a regular menstrual cycle of 30+/-5 days
* women 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
* women received written and oral information and signed an informed consent

For control groups:

* 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.

Exclusion Criteria:

* Ongoing pelvic and/or systemic infection
* Chronic infectious endometritis
* Active neoplasia
* Autoimmune and autoinflammatory disease
* Celiac disease
* Thrombophilia (including positive anti-phospholipid antibodies)
* Endocrine pathology (including dysthyroidism and diabetes)
* Endometriosis
* Polycystic ovary syndrome and ovulatory disorders
* Premature ovarian failure
* IVF by oocyte donation
* Tubal obstructions or lesions, uterine and cervical anomalies
* Partners with extreme oligoastheno-spermia and/or sperm DNA fragmentation \>30
* Sperm donations
* Patients unable to give informed consent

Where it's running

• Centre Hospitalier Universitaire d'Amiens
  Amiens, Picardie, France Recruiting

Study contacts

• Study coordinator: Amandine Dernoncourt, DR
• Email: dernoncourt.amandine@chu-amiens.fr
• Phone: 03. 22. 66. 82. 30

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.