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Completed

NCT Number: NCT04584047

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

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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Key information

Conditions

Prenatal Diagnoses Preimplantation Genetic Diagnosis

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fertility Unit, Aalborg University Hospital

Aalborg, 9000, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Achieved pregnancy following preimplantation genetic testing

Exclusion criteria

  • None

Treatment and study plan

Cell-based non-invasive prenatal testing

Procedure

Blood sampling.

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Aalborg University Hospital

Other

Collaborators

  • Aarhus University Hospital
  • Arcedi Biotech
  • Horsens Hospital
  • Kolding Sygehus
  • Randers Regional Hospital
  • Rigshospitalet, Denmark
  • Viborg Regional Hospital

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 12, 2020
Registry last updated
Jan 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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