Cell-free DNA Analysis of Chromosome Anomalies in Early Pregnancy Loss

Early Pregnancy Loss Clinical Trial

Official title:

Cell-free DNA Analysis of Chromosome Anomalies in Early Pregnancy Loss

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04935138
• Other study ID #: CD20-011
• Status: Terminated
• Start date: June 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: November 2023
• Source: Quest Diagnostics-Nichols Insitute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study assesses the accuracy of cell-free DNA (cfDNA) analysis in detecting whole chromosomal aneuploidies from maternal plasma of patients with early, missed miscarriage.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 78
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• 5-20 weeks of gestation by ultrasound

• Miscarriage diagnosed by ultrasound

• Pregnancy tissue still present in utero, including an empty sac, and not completely expelled

Exclusion Criteria:

• Maternal age < 18 years

• 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

Related Conditions & MeSH terms

• Abortion, Spontaneous
• Chromosome Aberrations
• Chromosome Disorders
• Early Pregnancy Loss
• Fetal Death

Intervention

Genetic:
• cfDNA analysis
sequencing data from cfDNA analysis

Locations

Country	Name	City	State
United States	Quest Diagnostics	San Juan Capistrano	California

Sponsors (2)

Lead Sponsor	Collaborator
Quest Diagnostics-Nichols Insitute	Illumina, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

ESHRE. European Society of Human Reproduction and Embryology guideline: recurrent pregnancy loss. Human Reproduction Open 2018: 1-12.

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	microarray analysis of products of conception (POC)	chromosome anomalies	7 days