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

NCT05894356 | Completed

• 1 other identifier: 3287
• Study Type: observational
• Target: 4,250
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Men undergoing sperm DNA fragmentation test

Men presenting at the clinic for infertility evaluation

Other: Study chart review

Interventions

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

Men undergoing sperm DNA fragmentation test

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Sperm sample
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male patients presenting for infertility evaluation from all ages, ethnicities, and medical histories.

You may qualify if:

• Male of at least 18 years of age

Sponsors & Collaborators

• Clinique Ovo: lead

Study Sites (1)

Clinique Ovo

Montreal, Quebec, H4P 2S4, Canada

Location

MeSH Terms

Conditions

Infertility, Male

Condition Hierarchy (Ancestors)

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

Study Officials

• Jacques Kadoch, MD

  Clinique Ovo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2023
• First Posted: June 8, 2023
• Study Start: June 10, 2023
• Primary Completion: December 31, 2023
• Study Completion: January 30, 2024
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)