Prenatal DiagnosesNCT04584047
Cell Based Non Invasive Prenatal Testing as an Alternative to Chorionic Villus Sampling Following Preimplantation Genetic Testing
A study testing Cell-based non-invasive prenatal testing in people with Prenatal Diagnoses and Preimplantation Genetic Diagnosis, run by Aalborg University Hospital at 1 site in Denmark.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Prenatal Diagnoses, Preimplantation Genetic Diagnosis
- What is being tested?
- Cell-based non-invasive prenatal testing
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteDenmark
- Study dates
- 18 Jun 2018to 21 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Achieved pregnancy following preimplantation genetic testing
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
- Being tested
- Cell-based non-invasive prenatal testing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cell-based non-invasive prenatal testingProcedure or surgery
Blood sampling.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | This arm has blood collected either at the time of CVS. Receives: Procedure: Cell-based non-invasive prenatal testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between cbNIPT and CVS (The gold standard)
How do the cbNIPT results compare to the results of the genetic test following CVS
Measured: Immidiately after the results from cbNIPT and CVS has been obtained
Secondary outcomes (2)
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.
Measured: Immidiately after genetic testing of the isolated fetal cells
Effectiveness of testing the genetic variant of interest
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.
Measured: Immidiately after genetic testing of the isolated fetal cells
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2020
- Study start18 Jun 2018
- Primary completion21 Nov 2019
- Study completion21 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prenatal DiagnosesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Arcedi Biotech, Aarhus University Hospital, Viborg Regional Hospital, Horsens Hospital, Randers Regional Hospital, Kolding Sygehus, Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Principal investigator, Christian Liebst Frisk Toft, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04584047
- Sponsor's protocol ID
- N-20180001
- Status last verified
- Jan 2024
- First submitted
- 23 Sep 2020
- Last updated
- 31 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD is shared upon request to the principal investigator.
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04584047
- Acronym / sponsor ID
- N-20180001
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Collaborators
- Arcedi Biotech, Aarhus University Hospital, Viborg Regional Hospital, Horsens Hospital, Randers Regional Hospital, Kolding Sygehus, Copenhagen University Hospital, Rigshospitalet
- Study start
- 18 Jun 2018 (actual)
- Primary completion
- 21 Nov 2019 (actual)
- Study completion
- 21 Nov 2019 (actual)
- First posted
- 12 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Procedure: Cell-based non-invasive prenatal testingThis arm has blood collected either at the time of CVS. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Achieved pregnancy following preimplantation genetic testing
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cell-based non-invasive prenatal testingBlood sampling. | Procedure or surgery | Intervention group |
Primary outcome
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
2 secondary outcomes
Effectiveness of fetal cell isolation
Time frame: Immidiately after genetic testing of the isolated fetal cells
Effectiveness of testing the genetic variant of interest
Time frame: Immidiately after genetic testing of the isolated fetal cells
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Individual participant dataSharing planned: Yes. IPD is shared upon request to the principal investigator.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cell-based non-invasive prenatal testing in people with Prenatal Diagnoses and Preimplantation Genetic Diagnosis, run by Aalborg University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement between cbNIPT and CVS (The gold standard) (time frame: Immidiately after the results from cbNIPT and CVS has been obtained). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2024.