Non-invasive Monitoring of Miscarriage

Recruiting

• Conditions: Miscarriage in First Trimester

• Registration Number: NCT06581692
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

cfDNA is extremely useful to ascertain chromosomal causes of miscarriages at the point of miscarriage diagnosis by a simple blood test. This study aims to determine the level of cell-free DNA (cfDNA) in early pregnancy and compare the results with those of product of conception (POC) testing, in concordance with standard karyotyping.

Detailed Description

Pregnancies achieved by assisted reproductive technologies (ART) are closely monitored, therefore miscarriages that occur very early in the pregnancy are frequently meticulously recorded and reported. On the other hand, spontaneous abortion rates among naturally occurring conceptions are notoriously hard to quantify and are often overstated when using criteria from assisted reproductive technologies. Additionally, women who have undergone treatment with ART are a particular population with traits that can make them more vulnerable to spontaneous abortions.

cfDNA would be extremely useful to ascertain chromosomal causes of miscarriages at the point of miscarriage diagnosis by a simple blood test. This study aims to determine the level of cell-free DNA (cfDNA) in early pregnancy and compare the results with those of product of conception (POC) testing, in concordance with standard karyotyping.

Study Timeline

• Study First Submitted: 2024-08-23
• Study First Submitted QC: 2024-08-30
• Study Start: 2024-09-01
• Study First Posted: 2024-09-03
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-11
• Last Update Posted: 2024-11-12
• Primary Completion: 2039-08-31
• Study Completion: 2039-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Age 18-45 years.
2. Women who attend the early pregnancy loss clinic or Patients who receive ART
3. Their partner, the biological father of the pregnancy

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Exclusion Criteria

• History of psychological/ psychiatric problem
• Patient refusal

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cell-free DNA (cfDNA)	15 weeks	Determine the use of cfDNA to ascertain chromosomal causes of miscarriages

Secondary Outcome Measures

Name	Time	Method
Level of cell-free DNA	15 weeks	To determine the level of cell-free DNA (cfDNA) in early pregnancy
Aneuploidy results from product of conception	15 weeks	To compare the aneuploidy results from product of conception (POC), in concordance with standard karyotyping.

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇭🇰 Hong Kong, Hong Kong