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Paternal Age and Fetal Aneuploidy

NCT05981521 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 7141

Last updated 2025-12-09

No results posted yet for this study

Summary

Trisomy 21, commonly known as down syndrome, is the most common chromosomal abnormality in humans. Advanced maternal age (AMA) is a well-recognized risk factor for trisomy 21, with the risk increasing significantly beyond the age of 35. Research on the effects of paternal age on the prenatal risk of trisomy 21 is lacking, with inconsistent findings in the literature.

The Harmony® prenatal test is an Non-Invasive Prenatal Testing (NIPT) that screens maternal blood for chromosomal abnormalities in the Cell-Free Fetal DNA (cfDNA). The harmony® prenatal test can detect conditions such as trisomy 13, 18, and 21, as well as sex chromosome abnormalities.

The Optimo test is a prenatal screening test that screens for trisomies 13, 18 and 21 in the developing fetus using extended biochemical screening in maternal. The Optimo test has shown high sensitivity and specificity in detecting trisomy 21.

Conditions

  • Trisomy 21

Interventions

DIAGNOSTIC_TEST

Optimo prenatal screening test

Prenatal screening test done between weeks 11 and 13 of pregnancy to detect conditions such as trisomy 13, 18 and 21

Sponsors & Collaborators

  • Clinique Ovo

    lead INDUSTRY

Principal Investigators

  • Jacques I Kadoch, MD · clinique ovo R&D department

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-31
Primary Completion
2024-12-31
Completion
2025-06-13

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05981521 on ClinicalTrials.gov