Image

Cohort of Patients Presenting Unexplained Recurrent Miscarriages and Identification of Early Miscarriage Recidivism Factors

Cohort of Patients Presenting Unexplained Recurrent Miscarriages and Identification of Early Miscarriage Recidivism Factors

Recruiting
18-50 years
Female
Phase N/A

Powered by AI

Overview

About 1 to 3% of women of childbearing age suffer repeated early spontaneous miscarriages (RCF) defined by at least 3 fetal losses before 14 weeks of gestation. RCFs may be linked to parental chromosomal abnormalities, congenital or acquired uterine abnormalities, hormonal causes (e.g. type 1 and 2 diabetes, ovarian failure), infectious etiology, constitutional or acquired thrombophilia or sickle cell disease.

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.

Description

The study population will be followed as part of routine care, in the same way as all patients presenting with RPL, in internal medicine or obstetrics-gynecology.

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).

Eligibility

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

Study details
    Miscarriage
    Early Pregnancy Loss

NCT05557201

Assistance Publique - Hôpitaux de Paris

1 February 2026

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.