Trials / Completed
CompletedNCT05453474
Cell-based Non-invasive Prenatal Testing as an Alternative to Invasive Chorionic Villus Sampling
Cell-based Non-invasive Prenatal Testing - Evaluation of Time of Blood Sampling and Whole Genome Amplification Prior to Genetic Testing
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 48 (actual)
- Sponsor
- Aalborg University Hospital · Academic / Other
- Sex
- Female
- Age
- —
- Healthy volunteers
- Accepted
Summary
The study aims to evaluate cell-based non-invasive prenatal testing (cbNIPT) as an alternative to invasive chorionic villus sampling (CVS) in patients who achieve pregnancy following preimplantation genetic testing for hereditary disorders.
Detailed description
The study has three main objects: 1. to evaluate the optimal time of blood sampling (gestational week 7-8 or 11-14) 2. to evaluate whole genome amplification prior to genetic analysis og isolated fetal cells (only relevant for monogenic disorders) 3. evaluating specificity and sensitivity
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| GENETIC | Whole genome amplification | DNA is amplified by whole genome amplification |
Timeline
- Start date
- 2021-08-08
- Primary completion
- 2023-06-27
- Completion
- 2023-06-27
- First posted
- 2022-07-12
- Last updated
- 2024-01-31
Locations
1 site across 1 country: Denmark
Source: ClinicalTrials.gov record NCT05453474. Inclusion in this directory is not an endorsement.