Understanding early pregnancy loss through genetic analysis
Study of Product of Conception Derived From Ultrasound-guided Manual Vacuum Aspiration
This study is trying to find out if genetic and immune factors play a role in early pregnancy loss by analyzing tissue from miscarriages to see if there are any hidden genetic issues.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Chinese University of Hong Kong Academic / other |
| Locations | 1 site (Hong Kong) |
| Trial ID | NCT05825183 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the genetic and immunological factors contributing to early pregnancy loss, which affects approximately one in four women. It focuses on analyzing products of conception obtained through ultrasound-guided manual vacuum aspiration (MVA) to identify chromosomal abnormalities and other genetic factors that may not be detectable by conventional karyotyping. The study utilizes next-generation sequencing (NGS) to enhance the detection of genomic variants, including copy-number variants and low-level chromosomal mosaicisms. By improving the understanding of the genetic underpinnings of miscarriage, the study seeks to provide insights into potential causes and future interventions.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 and older who have experienced a first trimester miscarriage or termination of pregnancy and are suitable for manual vacuum aspiration.
Not a fit: Patients who are not feasible candidates for the MVA procedure due to conditions like cervical stenosis or uterine malformations may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved diagnostic methods for early pregnancy loss, helping to identify underlying genetic causes and guiding future reproductive decisions.
How similar studies have performed: While the approach of using next-generation sequencing for genetic analysis in early pregnancy loss is gaining traction, this specific methodology and its application in this context may be novel and less explored.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Women 18 years old or above 2. Women with miscarriage or TOP who are suitable candidates for MVA * first trimester miscarriage or TOP * No fetal heart beat or TOP in those with CRL 25mm * incomplete miscarriage or TOP with POG \<5cm * hemodynamically stable, * tolerates well with speculum examination Exclusion Criteria: 1. Women who are not feasible for the MVA procedure * cervical stenosis * fibroid uterus \>12 weeks in size * known uterine malformation * bleeding disorder * clinically sepsis * inability to tolerate pelvic examination 2. History of psychological/ psychiatric problem 3. Patient refusal
Where this trial is running
Hong Kong
- Prince of Wales Hospital — Hong Kong, Hong Kong (Recruiting)
Study contacts
- Principal investigator: Pui Wah Jacqueline Chung — Prince of Wales Hospital
- Study coordinator: Pui Wah Jacqueline Chung
- Email: jacquelinechung@cuhk.edu.hk
- Phone: 35051537
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.