Recurrent Pregnancy Loss Clinical Trial
— GPRPLOfficial title:
Large Scale Genome Sequencing and Integrative Analyses to Define Genomic Predictors of Recurrent Pregnancy Loss
The overall goals of this proposal are to determine the genetic architecture of recurrent pregnancy loss (RPL) and to discover genomic predictors of RPL.
Status | Recruiting |
Enrollment | 1000 |
Est. completion date | September 2026 |
Est. primary completion date | September 2026 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 50 Years |
Eligibility | 1. Women with loss of a current singleton pregnancy at < 20 0/7 weeks gestation (documented by ultrasonography or histopathological examination) and one or more prior pregnancy losses. 2. Euploid current pregnancy by karyotype or microarray (a limited number of aneuploid losses will be included as part of the pilot) 3. No history of parental karyotype abnormalities 4. No history of antiphospholipid antibody syndrome 5. No evidence of uncontrolled diabetes 6. No evidence of uncontrolled thyroid disease 7. No history of autoimmune disease (SLE, RA) 8. No history of uterine anomalies 9. No history of cervical insufficiency |
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado | Aurora | Colorado |
United States | University of Texas at Austin | Austin | Texas |
United States | Gaelle Massoud | Baltimore | Maryland |
United States | Northwestern University | Chicago | Illinois |
United States | University of Chicago | Chicago | Illinois |
United States | Wayne State University | Detroit | Michigan |
United States | Pennsylvania State University | Hershey | Pennsylvania |
United States | Yale University | New Haven | Connecticut |
United States | Columbia University | New York | New York |
United States | University of Oklahoma | Oklahoma City | Oklahoma |
United States | University of Texas at San Antonio | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
Yale University | Columbia University, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Johns Hopkins University, Northwestern University, Penn State University, The University of Texas Health Science Center at San Antonio, University of Chicago, University of Colorado, Denver, University of Oklahoma, University of Texas at Austin, Wayne State University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determine genetic etiology for Recurrent Pregnancy Loss | The WGS tool will be used to analyze the POC sample and parental blood samples to determine the clinical reportable genetic cause for RPL | 5 years |
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