NCT05981521

Paternal Age and Fetal Aneuploidy

Exploring the Association Between Paternal Age and Trisomy 21 Screening Results.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 7,141 (actual)
• Sponsor: Clinique Ovo · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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

Timeline

• Start date: 2023-07-31
• Primary completion: 2024-12-31
• Completion: 2025-06-13
• First posted: 2023-08-08
• Last updated: 2025-12-09

Locations

1 site across 1 country: Canada