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| Name | Class |
|---|---|
| Arcedi Biotech | INDUSTRY |
| Aarhus University Hospital | OTHER |
| Viborg Regional Hospital | OTHER |
| Horsens Hospital |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | This arm has blood collected either at the time of CVS. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cell-based non-invasive prenatal testing | Procedure | Blood sampling. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Effectiveness of testing the genetic variant of interest |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fertility Unit, Aalborg University Hospital | Aalborg | 9000 | Denmark |
IPD is shared upon request to the principal investigator.
Upon request
Contact via principal investigator
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| OTHER |
| Randers Regional Hospital | OTHER |
| Kolding Sygehus | OTHER |
| Rigshospitalet, Denmark | OTHER |
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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 |