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NCT05894356 Clinical Trial

The Paternal Clock: Uncovering the Consequences of Advanced Paternal Age on Sperm DNA Fragmentation

Infertility, Male Clinical Trial

— Paternal Clock  

Official title:
The Paternal Clock: Uncovering the Consequences of Advanced Paternal Age on Sperm DNA Fragmentation

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05894356
Other study ID # 3287
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 10, 2023
Est. completion date January 30, 2024

Study information
Verified date February 2024
Source Clinique Ovo
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Sperm DNA fragmentation (SDF) serves as a marker for chromatin and DNA damage in sperm. Assessing sperm DNA integrity is crucial in male fertility evaluation since high levels of SDF are associated with a greater number of adverse reproductive outcomes, including an increased risk of miscarriage and birth defects. Recent research suggests that advanced paternal age (APA) may lead to DNA damage in sperm, however the precise age at which this risk becomes apparent has not yet been clearly defined, necessitating the identification of the point in time at which high SDF levels occur. With the help of this knowledge, male infertility can be diagnosed with greater accuracy, and infertile couples can receive appropriate care.

Recruitment information / eligibility
Status Completed
Enrollment 4250
Est. completion date January 30, 2024
Est. primary completion date December 31, 2023
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: - Male of at least 18 years of age

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Study chart review
Evaluation of 4250 sperm DNA fragmentation samples with the goal of defining a cut-off age beyond which SDF levels increase significantly

Locations
Country Name City State
Canada Clinique Ovo Montreal Quebec

Sponsors (1)
Lead Sponsor Collaborator
Clinique Ovo

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Investigate the impact of advanced paternal age on sperm DNA fragmentation Comparing mean sperm DNA fragmentation throughout the chart review of different age groups Up to 3 weeks
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