Finding causes of unexplained repeated early miscarriages
Cohort of Patients Presenting Unexplained Recurrent Miscarriages and Identification of Early Miscarriage Recidivism Factors
Assistance Publique - Hôpitaux de Paris · NCT05557201
This project will collect medical and biological data from women aged 18–50 who have had three or more early miscarriages or repeated implantation failures to try to find factors linked to repeat pregnancy loss.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 700 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | Assistance Publique - Hôpitaux de Paris (other) |
| Locations | 1 site (Paris) |
| Trial ID | NCT05557201 on ClinicalTrials.gov |
What this trial studies
This is an observational cohort of patients presenting with recurrent early pregnancy loss or repeated implantation failure who will be followed as part of routine care at a single center. On inclusion, investigators will record detailed medical, obstetric, lifestyle and demographic histories and compile data for each prior pregnancy, including outcomes and treatments. Biological samples and standard laboratory tests (including screening for antiphospholipid, antithyroid and other antibodies) will be collected or reviewed when available to search for prognostic factors. No experimental interventions are given; participants continue usual clinical care while their data are analyzed to identify patterns linked to recurrence.
Who should consider this trial
Good fit: Women aged 18–50 with at least three early pregnancy losses before 14 weeks of amenorrhea or at least three implantation failures who consent to use of their medical data and have social security coverage.
Not a fit: Patients with a clearly identified and unavoidable cause of miscarriage (for example a known parental chromosomal abnormality), those under legal protection, or those who do not consent to data use are unlikely to benefit from this observational data collection.
Why it matters
Potential benefit: If successful, the findings could help identify immune, genetic or other risk factors so clinicians can offer more targeted testing and tailored management to reduce future miscarriages.
How similar studies have performed: Previous observational work has identified some immune and genetic contributors to recurrent miscarriage but about half of cases remain unexplained, so this project builds on existing findings to seek additional prognostic markers.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 18 to 50 years * Patients who have had 3 (or more) early pregnancy losses occurring before 14 weeks of amenorrhea and/or at least 3 implantation failures. * Patients who have been informed and have not objected to participating in the study. * Patients covered by a social security system. Exclusion Criteria: * patients who do not agree the use of their data * Patients on AME * Patients under legal protection
Where this trial is running
Paris
- Internal medicine department, hospital Saint Antoine — Paris, France (RECRUITING)
Study contacts
- Principal investigator: Arsene MEKINIAN, MD, PhD — Assistance Publique - Hôpitaux de Paris
- Study coordinator: Arsene MEKINIAN, MD, PhD
- Email: arsene.mekinian@aphp.fr
- Phone: 1 71 97 07 65
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Miscarriage, Early Pregnancy Loss, Prognostic factors, Biological collection, recurrent early pregnancy losses, repeated implantation failure