NCT04584047CompletedNot Applicable
Evaluation of Cell-based Non-invasive Prenatal Testing as an Alternative to Chorionic Villus Sampling as a Tool to Confirm the Pregnancy With an Unaffected Fetus Following Preimplantation Genetic Testing
Aalborg University Hospital1 site in 1 country8 target enrollmentStarted: June 18, 2018Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Aalborg University Hospital
- Enrollment
- 8
- Locations
- 1
- Primary Endpoint
- Agreement between cbNIPT and CVS (The gold standard)
Study Overview
Brief Summary
The study aims to investigate whether cell-based non-invasive prenatal testing (cbNIPT) can be used as an alternative to invasive chorionic villus sampling (CVS) in patients who achieve pregnancy following preimplantation genetic testing for monogenic disorders (PGT-M).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Achieved pregnancy following preimplantation genetic testing
Exclusion Criteria
- Not provided
Arms & Interventions
Intervention group
Experimental
This arm has blood collected either at the time of CVS.
Intervention: Cell-based non-invasive prenatal testing (Procedure)
Outcomes
Primary Outcomes
Agreement between cbNIPT and CVS (The gold standard)
Time Frame: Immidiately after the results from cbNIPT and CVS has been obtained
How do the cbNIPT results compare to the results of the genetic test following CVS
Secondary Outcomes
- Effectiveness of fetal cell isolation(Immidiately after genetic testing of the isolated fetal cells)
- Effectiveness of testing the genetic variant of interest(Immidiately after genetic testing of the isolated fetal cells)
Investigators
Christian Liebst Frisk Toft
Molecular Biologist, Ph.D. fellow
Aalborg University Hospital
Study Sites (1)
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