Paternal Age and Fetal Aneuploidy

Trisomy 21 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05981521
• Other study ID #: 3321
• Status: Active, not recruiting
• Start date: July 31, 2023
• Est. completion date: July 31, 2025

Study information

• Verified date: February 2024
• Source: Clinique Ovo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30000
• Est. completion date: July 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Down Syndrome
• Trisomy 21

Intervention

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

Locations

Country	Name	City	State
Canada	Clinique Ovo	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Clinique Ovo

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	3 to 5 days