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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04584047
Recruitment Status : Recruiting
First Posted : October 12, 2020
Last Update Posted : October 12, 2020
Sponsor:
Collaborators:
ARCEDI Biotech
Aarhus University Hospital
Viborg Regional Hospital
Horsens Hospital
Randers Regional Hospital
Kolding Sygehus
Rigshospitalet, Denmark
Information provided by (Responsible Party):
Christian Liebst Frisk Toft, Aalborg University Hospital

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
Prenatal Diagnoses Preimplantation Genetic Diagnosis Procedure: Cell-based non-invasive prenatal testing Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : June 18, 2018
Estimated Primary Completion Date : June 15, 2021
Estimated Study Completion Date : June 15, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Genetic Testing

Arm Intervention/treatment
Experimental: Intervention group
This arm had blood collected at the time of CVS.
Procedure: Cell-based non-invasive prenatal testing
Blood sampling.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Achieved pregnancy following preimplantation genetic testing

Exclusion Criteria:

  • None

Information from the National Library of Medicine

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


Contacts
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Contact: Christian Liebst Frisk Toft, Molecular Biologist +45 26245209 christian.toft@rn.dk

Locations
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Denmark
Fertility Unit, Aalborg University Hospital Recruiting
Aalborg, Denmark, 9000
Contact: Hans Jakob Ingerslev, Professor, M.D.    +45 50939393    jakob.ingerslev@rn.dk   
Sponsors and Collaborators
Aalborg University Hospital
ARCEDI Biotech
Aarhus University Hospital
Viborg Regional Hospital
Horsens Hospital
Randers Regional Hospital
Kolding Sygehus
Rigshospitalet, Denmark
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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: October 12, 2020    Key Record Dates
Last Update Posted: October 12, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD is shared upon request to the principal investigator.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Upon request
Access Criteria: Contact via principal investigator

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No