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Completed

NCT Number: NCT05894356

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

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.

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Key information

Conditions

Infertility, Male Genital Diseases Genital Diseases, Male Infertility Male Urogenital Diseases Urogenital Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Clinique Ovo

Montreal, Quebec, H4P 2S4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male of at least 18 years of age

Treatment and study plan

Study chart review

Other

Evaluation of 4250 sperm DNA fragmentation samples with the goal of defining a cut-off age beyond which SDF levels increase significantly

Primary outcomes

  1. Investigate the impact of advanced paternal age on sperm DNA fragmentation

    Time frame: Up to 3 weeks

    Comparing mean sperm DNA fragmentation throughout the chart review of different age groups

Sponsors and collaborators

Lead sponsor

Clinique Ovo

Industry

Registry information

Acronym: Paternal Clock

Important dates

Study start
2023
Primary completion
2023
Study completion
2024
First posted
Jun 8, 2023
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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