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Non-invasive Monitoring of Miscarriage

Non-invasive Monitoring of Miscarriage

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06581692
Enrollment
150
Registered
2024-09-03
Start date
2024-09-01
Completion date
2039-08-31
Last updated
2024-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Miscarriage in First Trimester

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.

Interventions

OTHERThis is a routine procedure, no intervention will be provided.

This is a routine procedure, no intervention will be provided.

Sponsors

Chinese University of Hong Kong
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 45 Years

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

Exclusion criteria

* History of psychological/ psychiatric problem * Patient refusal

Design outcomes

Primary

MeasureTime frameDescription
Cell-free DNA (cfDNA)15 weeksDetermine the use of cfDNA to ascertain chromosomal causes of miscarriages

Secondary

MeasureTime frameDescription
Level of cell-free DNA15 weeksTo determine the level of cell-free DNA (cfDNA) in early pregnancy
Aneuploidy results from product of conception15 weeksTo compare the aneuploidy results from product of conception (POC), in concordance with standard karyotyping.

Countries

Hong Kong

Contacts

Primary ContactPUI WAH JACQUELINE CHUNG
jacquelinechung@cuhk.edu.hk+852 35051764
Backup ContactYee Lee Elaine NG
elaineng@cuhk.edu.hk+852 35052745

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026