An observational study in Trisomy 21, sponsored by Clinique Ovo. Completed at 1 site in Canada. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-09.
Sponsored by Clinique Ovo · Observational
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.
432 studies on the registry are indexed under Down Syndrome; 100 are open to participants now.
This study's enrollment of 7,141 is above the median of 150 across 141 observational studies indexed under Down Syndrome.
Browse Down Syndrome studies →Clinique Ovo is the lead sponsor of 35 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Pregnant women who underwent Optimo trisomy 21 screening at clinique ovo between January 2014 to June 2023
Exclusion Criteria:
Prenatal screening test done between weeks 11 and 13 of pregnancy to detect conditions such as trisomy 13, 18 and 21
Trisomy 21 screening results
On the day of the Optimo screening test, a questionnaire concerning clinical data (maternal and paternal age, ethnicity, weight, smoking status, pregnancy history) is completed. Blood test and nuchal transparency are done on that day. Results from serum analysis and nuchal transparency are combined to assess the risk of trisomy 21. Association between paternal age and trisomy 21 screening results will be assessed afterwards
Time frame: 3 to 5 days
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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