Skip to main content
OpenTrials
Completed

NCT Number: NCT05453474

Cell-based Non-invasive Prenatal Testing as an Alternative to Invasive Chorionic Villus Sampling

The study aims to evaluate cell-based non-invasive prenatal testing (cbNIPT) as an alternative to invasive chorionic villus sampling (CVS) in patients who achieve pregnancy following preimplantation genetic testing for hereditary disorders.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Hereditary Diseases Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fertility Unit, Aalborg University Hospital

Aalborg, 9000, Denmark

About this study

The study has three main objects:

  • to evaluate the optimal time of blood sampling (gestational week 7-8 or 11-14)
  • to evaluate whole genome amplification prior to genetic analysis og isolated fetal cells (only relevant for monogenic disorders)
  • evaluating specificity and sensitivity

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Pregnancy following preimplantation genetic testing

Exclusion criteria

  • None

Treatment and study plan

Whole genome amplification

Genetic

DNA is amplified by whole genome amplification

Primary outcomes

  1. Evaluation of the fetal cell yield when blood sampling is performed at Gestational weeks 7-8 compared to gestational weeks 11-14.

    Time frame: Within 2 years

    Evaluation of whether cbNIPT be performed in gestational week 7-8.

  2. Percentage of test with an informative test result from genetic testing following whole genome amplification or direct testing without whole genome amplification.

    Time frame: Within 2 years (since data analysis is carried out later than sample collection)

    Analysis of whether genetic testing on whole genome amplified material is inferior to genetic testing directly on DNA purified from single cells.

  3. Specificity and sensitivity of single cell analysis.

    Time frame: Within 2 years

    Evaluation of the sensitivity and specificity of single cell analysis.

Sponsors and collaborators

Lead sponsor

Aalborg University Hospital

Other

Collaborators

  • Aarhus University Hospital
  • Arcedi Biotech

Registry information

Official study title

Cell-based Non-invasive Prenatal Testing - Evaluation of Time of Blood Sampling and Whole Genome Amplification Prior to Genetic Testing

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jul 12, 2022
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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.