Cell Based Non Invasive Prenatal Testing as an Alternative to Chorionic Villus Sampling Following Preimplantation Genetic Testing
Sponsor
Aalborg University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04584047
Collaborator
ARCEDI Biotech (Other), Aarhus University Hospital (Other), Viborg Regional Hospital (Other), Horsens Hospital (Other), Randers Regional Hospital (Other), Kolding Sygehus (Other), Rigshospitalet, Denmark (Other)
40
1
1
66.5
0.6
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
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
Actual Study Start Date
:
Jun 18, 2018
Anticipated Primary Completion Date
:
May 15, 2023
Anticipated Study Completion Date
:
Jan 1, 2024
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention group This arm has blood collected either at the time of CVS. |
Procedure: Cell-based non-invasive prenatal testing
Blood sampling.
|
Outcome Measures
Primary Outcome Measures
- Agreement between cbNIPT and CVS (The gold standard) [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 Outcome Measures
- Effectiveness of fetal cell isolation [Immidiately after genetic testing of the isolated fetal cells]
How large a fraction of the potential fetal cells isolated is verified by genetic testing to be of fetal origin.
- Effectiveness of testing the genetic variant of interest [Immidiately after genetic testing of the isolated fetal cells]
How often does the test on a fetal cell yield a result that allows determination of the mutational status of the embryo with respect to the genetic variant of interest.
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Achieved pregnancy following preimplantation genetic testing
Exclusion Criteria:
- None
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fertility Unit, Aalborg University Hospital | Aalborg | Denmark | 9000 |
Sponsors and Collaborators
- Aalborg University Hospital
- ARCEDI Biotech
- Aarhus University Hospital
- Viborg Regional Hospital
- Horsens Hospital
- Randers Regional Hospital
- Kolding Sygehus
- Rigshospitalet, Denmark
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Christian Liebst Frisk Toft,
Molecular Biologist, Ph.D. fellow,
Aalborg University Hospital
ClinicalTrials.gov Identifier:
NCT04584047
Other Study ID Numbers:
- N-20180001
First Posted:
Oct 12, 2020
Last Update Posted:
Mar 4, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: