Cell Based Non Invasive Prenatal Testing as an Alternative to Chorionic Villus Sampling Following Preimplantation Genetic Testing
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|ClinicalTrials.gov Identifier: NCT04584047|
Recruitment Status : Recruiting
First Posted : October 12, 2020
Last Update Posted : October 12, 2020
|Condition or disease||Intervention/treatment||Phase|
|Prenatal Diagnoses Preimplantation Genetic Diagnosis||Procedure: Cell-based non-invasive prenatal testing||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 :||June 18, 2018|
|Estimated Primary Completion Date :||June 15, 2021|
|Estimated Study Completion Date :||June 15, 2021|
Experimental: Intervention group
This arm had blood collected at the time of CVS.
Procedure: Cell-based non-invasive prenatal testing
- 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
- Effectiveness of fetal cell isolation [ Time Frame: 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 [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04584047
|Contact: Christian Liebst Frisk Toft, Molecular Biologist||+45 email@example.com|
|Fertility Unit, Aalborg University Hospital||Recruiting|
|Aalborg, Denmark, 9000|
|Contact: Hans Jakob Ingerslev, Professor, M.D. +45 50939393 firstname.lastname@example.org|