Cohort of Patients Presenting Unexplained Recurrent Miscarriages and Identification of Early Miscarriage Recidivism Factors
NCT ID: NCT05557201
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
700 participants
OBSERVATIONAL
2022-10-24
2029-10-31
Brief Summary
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The presence of antiphospholipid antibodies, antithyroid and anti-transglutaminase antibodies in approximately 10% of cases suggests an autoimmune origin for these fetal losses. The role of other antibodies, in particular non-conventional antiphospholipid antibodies, remains to be established. Indeed half of RCF cases are thought to be due to an immunological dysregulation of the mother leading to a decrease in tolerance to the fetus. Several studies have shown immune abnormalities, such as an imbalance of pro and anti-inflammatory cytokines, an increase in cytotoxic cells and a defect in regulatory cells in the blood of patients. The assessment of these immune abnormalities is not currently performed routinely in France in women presenting with recurrent early miscarriages. When one of these known causes is excluded, it is unexplained RCF which represents 50% of RCF. Over half of these women with RCF may be linked to aneuploidies and primary spontaneous recurrent abortions. Assessing the degree of aneuploidy and the genetic origin of foetal losses remains difficult to date, as examination of the miscarriage product is rarely available, due to the spontaneous nature of the loss.
An implantation failure (IF) is defined as the absence of pregnancy following the transfer of a good-quality embryo into the uterine cavity. These implantation failures can be due to embryonic factors, maternal factors, or caused by inappropriate stimulation and/or difficult transfers. In the literature, recurrent implantation failure (RIF) is defined as the absence of pregnancy after 3 attempts of transferring good-quality embryos, taking maternal age into account Setting up a prospective cohort of patients with RFC is an essential step in exploring the aetiological factors of RCF and in order to enable better treatment.
Detailed Description
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On the day of inclusion, the patient's medical history will be reviewed (demographic data, lifestyle factors, medical and obstetric-gynecologic history, biological tests performed).
Data for each of the patient's pregnancies will also be collected (date of pregnancy onset, type of pregnancy, pregnancy outcome, treatments taken during pregnancy, maternal/fetal complications during pregnancy).
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Miscarriage
Patients with recurrent early pregnancy losses (at least 3 fetal losses before 14 weeks of amenorrhea) and/or recurrent implantation failures (at least 3 failures).
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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 on AME
* Patients under legal protection
18 Years
50 Years
FEMALE
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Arsene MEKINIAN, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Assistance Publique - Hôpitaux de Paris
Locations
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Internal medicine department, hospital Saint Antoine
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Arsene MEKINIAN
Role: primary
References
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Dernoncourt A, Hedhli K, Abisror N, Cheloufi M, Cohen J, Kolanska K, McAvoy C, Selleret L, Ballot E, Mathieu d'Argent E, Chabbert Buffet N, Fain O, Kayem G, Mekinian A. Hydroxychloroquine in recurrent pregnancy loss: data from a French prospective multicenter registry. Hum Reprod. 2024 Sep 1;39(9):1934-1941. doi: 10.1093/humrep/deae146.
Other Identifiers
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IDRCB 2022-A00273-40
Identifier Type: OTHER
Identifier Source: secondary_id
APHP220747
Identifier Type: -
Identifier Source: org_study_id