Cell-free DNA Analysis of Chromosome Anomalies in Early Pregnancy Loss
NCT ID: NCT04935138
Last Updated: 2023-12-01
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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TERMINATED
78 participants
OBSERVATIONAL
2021-06-01
2022-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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cfDNA analysis
sequencing data from cfDNA analysis
Eligibility Criteria
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Inclusion Criteria
* Miscarriage diagnosed by ultrasound
* Pregnancy tissue still present in utero, including an empty sac, and not completely expelled
Exclusion Criteria
* No visible pregnancy tissue on ultrasound
* Multiple fetal gestation (\> than singleton)
* Pregnancy was conceived using in vitro fertilization (IVF) with preimplantation genetic testing for aneuploidy (PGT-A) performed on the transferred embryo
* No microarray testing is planned on the product of conception
* Previous normal non-invasive prenatal testing (NIPT) or diagnostic testing (chorionic villous sampling or amniocentesis) in the current pregnancy
* Patient unable to provide consent
18 Years
50 Years
FEMALE
No
Sponsors
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Illumina, Inc.
INDUSTRY
Quest Diagnostics-Nichols Insitute
INDUSTRY
Responsible Party
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Principal Investigators
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Pranoot X Tanpaiboon, MD
Role: PRINCIPAL_INVESTIGATOR
Quest Diagnostics-Nichols Insitute
Karen E Racicot, PhD
Role: PRINCIPAL_INVESTIGATOR
Quest Diagnostics-Nichols Insitute
Locations
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Quest Diagnostics
San Juan Capistrano, California, United States
Countries
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References
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Barisic I, Zergollern L, Muzinic D, Hitrec V. Risk estimates for balanced reciprocal translocation carriers--prenatal diagnosis experience. Clin Genet. 1996 Mar;49(3):145-51. doi: 10.1111/j.1399-0004.1996.tb03274.x.
ESHRE. European Society of Human Reproduction and Embryology guideline: recurrent pregnancy loss. Human Reproduction Open 2018: 1-12.
Kutteh WH, Miller CE, Park JK, Corey V, Chavez M, Racicot K, Alagia DP 3rd, Jinnett KN, Curnow K, Dalton K, Bhatt S, Keefe DL. Cell-Free DNA Analysis of Fetal Aneuploidies in Early Pregnancy Loss. J Clin Med. 2024 Jul 23;13(15):4283. doi: 10.3390/jcm13154283.
Practice Committee of the American Society for Reproductive Medicine. Evaluation and treatment of recurrent pregnancy loss: a committee opinion. Fertil Steril. 2012 Nov;98(5):1103-11. doi: 10.1016/j.fertnstert.2012.06.048. Epub 2012 Jul 24.
Other Identifiers
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CD20-011
Identifier Type: -
Identifier Source: org_study_id