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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-50
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

patients who do not agree the use of their data

Patients on AME

Patients under legal protection

Trial population

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).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

700 Participants
are grouped into 1 trial group
Group A: Miscarriage

Trial outcomes

Primary outcomes

1

To build a cohort of patients in order to describe clinical characteristics, tests carried out and medical care of patients presenting spontaneous recurrent miscarriages

Description of the clinical and biological characteristics of patients with recurrent early pregnancy losses and/or recurrent implantation failures

Time frame
through study completion, an average of 5 years

Secondary outcomes

1

To describe the recurrence rate of repeated early pregnancy loss

Proportion of recurrence of early pregnancy loss (EPL) over the entire duration of the study: according to the number of previous early pregnancy losses; according to abnormalities found in the etiological work-up; according to age at onset, associated infertility, type of pregnancy loss with or without live children, and according to the different treatments used

Time frame
Through study completion, an average of 5 years
2

To describe the recurrence rate of repeated implantation failure

Proportion of recurrence of RIF over the entire duration of the study: according to the number of previous implantation failures, according to abnormalities found in the etiological work-up, according to age at onset, associated infertility, and according to the different treatments used

Time frame
Through study completion, an average of 5 years
3

To compare the efficacy of immunomodulatory drugs (corticosteroids, hydroxycholoroquin, Intravenous Immunoglobulin Therapy, intralipids, biotherapies)

Description of the efficacy of the various drugs : number of full term pregnancies

Time frame
through study completion, an average of 5 years
4

To evaluate the psychological state of patients and the impact on pregnancy

Evaluation of the patients' lifestyle using the Baecke questionnaire and medical interrogation.

Time frame
through study completion, an average of 5 years

Other outcomes

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