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

NCT ID: NCT05894356

Last Updated: 2024-02-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

4250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-10

Study Completion Date

2024-01-30

Brief Summary

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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.

Detailed Description

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Conditions

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Infertility, Male

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Men undergoing sperm DNA fragmentation test

Men presenting at the clinic for infertility evaluation

Study chart review

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Male of at least 18 years of age
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Clinique Ovo

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jacques Kadoch, MD

Role: PRINCIPAL_INVESTIGATOR

Clinique Ovo

Locations

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Clinique Ovo

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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3287

Identifier Type: -

Identifier Source: org_study_id

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