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Father's age may matter in down syndrome screening, study suggests

NCT ID NCT05981521

Knowledge-focused Sponsor: Clinique Ovo Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This completed study of over 7,000 pregnant women looked at whether the father's age influences the chance of Down syndrome (trisomy 21) in the baby. While it's well known that the mother's age matters, the father's role is less clear. Researchers used a blood test called the Optimo prenatal screening to check for chromosomal conditions and compared results with both parents' ages.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If a link is found, it could improve how we estimate Down syndrome risk during pregnancy by including paternal age.
What could go wrong
This is an observational study, not a treatment trial. It only looks for an association, so it cannot prove cause and effect. Results may not change current screening guidelines.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

7,141 people

The number who actually took part.

Started

Jul 2023

Finished

Jun 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

Pregnant women who underwent Optimo trisomy 21 screening at clinique ovo between January 2014 to June 2023

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Pregnant women aged 18 years or older (at the time of trisomy 18 and 21 screening) and who were able to complete the questionnaire in either French or English * Pregnant women who completed the entire trisomy 21 screening process at clinique ovo were included Exclusion Criteria: * Patients who did not indicate the male partner/donor's age were excluded * Patients who did not complete or sign the clinical information form

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Conditions

The condition(s) this trial relates to.

Down syndrome trisomy 21

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Trisomy 21

Contacts and locations

Locations

  • Clinique Ovo

    Montreal, Quebec, H4P 2S4, Canada

More trials for these conditions

Other studies related to the condition(s) this trial covers.