NCT06581692

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
163mo left

Started Sep 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress11%
Sep 2024Aug 2039

First Submitted

Initial submission to the registry

August 23, 2024

Completed
9 days until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 3, 2024

Completed
15 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2039

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2039

Last Updated

November 12, 2024

Status Verified

November 1, 2024

Enrollment Period

15 years

First QC Date

August 23, 2024

Last Update Submit

November 11, 2024

Conditions

Miscarriage in First Trimester

Outcome Measures

Primary Outcomes (1)

  • Cell-free DNA (cfDNA)

    Determine the use of cfDNA to ascertain chromosomal causes of miscarriages

    15 weeks

Secondary Outcomes (2)

  • Level of cell-free DNA

    15 weeks

  • Aneuploidy results from product of conception

    15 weeks

Interventions

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

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

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Patients will be approached on the day of attending the early pregnancy loss clinic, and given information about the study. Sufficient time will be allowed for consideration before they confirm their decision and sign the consent. For cases with the management of ultrasound-guided manual vacuum aspiration (USG-MVA) or surgical evacuation, their remaining products of gestation will be collected for analysis.

You may qualify if:

  • 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

You may not qualify if:

  • History of psychological/ psychiatric problem
  • Patient refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood, Products of conception

Study Officials

  • PUI WAH JACQUELINE CHUNG

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

PUI WAH JACQUELINE CHUNG

CONTACT

+852 35051764jacquelinechung@cuhk.edu.hk

Yee Lee Elaine NG

CONTACT

+852 35052745elaineng@cuhk.edu.hk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 23, 2024

First Posted

September 3, 2024

Study Start

September 1, 2024

Primary Completion (Estimated)

August 31, 2039

Study Completion (Estimated)

August 31, 2039

Last Updated

November 12, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

HK(1)