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NCT Number: NCT06581692

Non-invasive Monitoring of Miscarriage

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.

Recruiting

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Prince of Wales Hospital

Hong Kong

Location status: Recruiting

Location contact

Jacqueline Pui Wah CHUNG, MBBS

CONTACT

[email protected]

30501537

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • History of psychological/ psychiatric problem
  • Patient refusal

Treatment and study plan

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

Other

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

Primary outcomes

  1. Cell-free DNA (cfDNA)

    Time frame: 15 weeks

    Determine the use of cfDNA to ascertain chromosomal causes of miscarriages

Secondary outcomes

  1. Level of cell-free DNA

    Time frame: 15 weeks

    To determine the level of cell-free DNA (cfDNA) in early pregnancy

  2. Aneuploidy results from product of conception

    Time frame: 15 weeks

    To compare the aneuploidy results from product of conception (POC), in concordance with standard karyotyping.

Study contacts

Contact information is provided by the study sponsor or research team.

PUI WAH JACQUELINE CHUNG

CONTACT

[email protected]

+852 35051764

Yee Lee Elaine NG

CONTACT

[email protected]

+852 35052745

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Important dates

Study start
2024
Primary completion
2039
Study completion
2039
First posted
Sep 3, 2024
Registry last updated
Nov 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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