NCT05894356

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 4,250 (actual)
• Sponsor: Clinique Ovo · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Infertility, Male

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-06-10
• Primary completion: 2023-12-31
• Completion: 2024-01-30
• First posted: 2023-06-08
• Last updated: 2024-02-20

Locations

1 site across 1 country: Canada