Identifying genetic factors in recurrent pregnancy loss

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 observational study aims to explore the genetic basis of recurrent pregnancy loss (RPL) by collecting and analyzing DNA samples from trios consisting of the product of conception, the biological mother, and the biological father. The study will recruit 1,000 rigorously characterized trios with unexplained RPL and perform whole genome sequencing at the Yale Center for Genome Analysis. The goal is to identify pathogenic genetic variants that could lead to novel gene discoveries and the development of clinical diagnostic tests for RPL.

Why it matters

Who can join: the full rules

Cohort A - Fetal Intolerome Cohort

Inclusion Criteria:

* Women with loss of a current singleton pregnancy at \< 20 0/7 weeks gestation, documented by ultrasonography or histopathological examination
* History of one or more prior pregnancy losses
* Euploid current pregnancy confirmed by karyotype, microarray, or STORK (Short-read Transpore Rapid Karyotyping) sequencing Note: A limited number of aneuploid losses will be included as part of the pilot phase

Exclusion Criteria:

* History of parental karyotype abnormalities
* History of antiphospholipid antibody syndrome
* Evidence of uncontrolled diabetes
* Evidence of uncontrolled thyroid disease
* History of autoimmune disease related to pregnancy loss (e.g., systemic lupus erythematosus, rheumatoid arthritis)
* History of uterine anomalies
* History of cervical insufficiency

Cohort B - Maternal Effect Gene Cohort

Inclusion Criteria:

\- Women with a history of three or more pregnancy losses of unknown cause, with or without a liveborn child

Exclusion Criteria:

\- Known etiology for pregnancy loss

Where it's running

• University of Colorado
  Aurora, Colorado, United States Recruiting
• Yale University
  New Haven, Connecticut, United States Recruiting
• Northwestern University
  Chicago, Illinois, United States Recruiting
• Johns Hopkins University
  Baltimore, Maryland, United States Recruiting
• Wayne State University
  Detroit, Michigan, United States Recruiting
• Columbia University
  New York, New York, United States Recruiting

Study contacts

• Study coordinator: Yong-Hui Jiang, MD, PhD
• Email: yong-hui.jiang@yale.edu
• Phone: 2037852429

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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.