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

February 16, 2024 updated by: Clinique Ovo

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

4250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H4P 2S4
        • Clinique ovo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • Male of at least 18 years of age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Men undergoing sperm DNA fragmentation test
Men presenting at the clinic for infertility evaluation
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 3 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinique Ovo

Investigators

  • Principal Investigator: Jacques Kadoch, MD, Clinique ovo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2023

Primary Completion (Actual)

December 31, 2023

Study Completion (Actual)

January 30, 2024

Study Registration Dates

First Submitted

May 30, 2023

First Submitted That Met QC Criteria

June 7, 2023

First Posted (Actual)

June 8, 2023

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 16, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3287

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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