NCT04584047

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 18, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 21, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 21, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2020

Completed
19 days until next milestone

First Posted

Study publicly available on registry

October 12, 2020

Completed
Last Updated

January 31, 2024

Status Verified

January 1, 2024

Enrollment Period

1.4 years

First QC Date

September 23, 2020

Last Update Submit

January 30, 2024

Conditions

Prenatal DiagnosesPreimplantation Genetic Diagnosis

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Effectiveness of fetal cell isolation

    Immidiately after genetic testing of the isolated fetal cells

  • Effectiveness of testing the genetic variant of interest

    Immidiately after genetic testing of the isolated fetal cells

Study Arms (1)

Intervention group

EXPERIMENTAL

This arm has blood collected either at the time of CVS.

Procedure: Cell-based non-invasive prenatal testing

Interventions

Cell-based non-invasive prenatal testingPROCEDURE

Blood sampling.

Intervention group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Achieved pregnancy following preimplantation genetic testing

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fertility Unit, Aalborg University Hospital

Aalborg, 9000, Denmark

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Molecular Biologist, Ph.D. fellow

Study Record Dates

First Submitted

September 23, 2020

First Posted

October 12, 2020

Study Start

June 18, 2018

Primary Completion

November 21, 2019

Study Completion

November 21, 2019

Last Updated

January 31, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will share

IPD is shared upon request to the principal investigator.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Upon request
Access Criteria
Contact via principal investigator

Locations

DK(1)