Cell Based Non Invasive Prenatal Testing as an Alternative to Chorionic Villus Sampling Following Preimplantation Genetic Testing

Preimplantation Genetic Diagnosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04584047
• Other study ID #: N-20180001
• Status: Completed
• Phase: N/A
• Start date: June 18, 2018
• Est. completion date: November 21, 2019

Study information

• Verified date: January 2024
• Source: Aalborg University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: November 21, 2019
• Est. primary completion date: November 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Achieved pregnancy following preimplantation genetic testing

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Disease
• Preimplantation Genetic Diagnosis
• Prenatal Diagnoses

Intervention

Procedure:
• Cell-based non-invasive prenatal testing
Blood sampling.

Locations

Country	Name	City	State
Denmark	Fertility Unit, Aalborg University Hospital	Aalborg

Sponsors (8)

Lead Sponsor	Collaborator
Aalborg University Hospital	Aarhus University Hospital, ARCEDI Biotech, Horsens Hospital, Kolding Sygehus, Randers Regional Hospital, Rigshospitalet, Denmark, Viborg Regional Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Agreement between cbNIPT and CVS (The gold standard)	How do the cbNIPT results compare to the results of the genetic test following CVS	Immidiately after the results from cbNIPT and CVS has been obtained
Secondary	Effectiveness of fetal cell isolation	How large a fraction of the potential fetal cells isolated is verified by genetic testing to be of fetal origin.	Immidiately after genetic testing of the isolated fetal cells
Secondary	Effectiveness of testing the genetic variant of interest	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.	Immidiately after genetic testing of the isolated fetal cells