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

Sponsor

Clinique Ovo (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05894356

Collaborator

(none)

4,250

Enrollment

Location

12.7

Anticipated Duration (Months)

335.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility, Male	Other: Study chart review

Study Design

Study Type:

Observational

Anticipated Enrollment :

4250 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

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

Anticipated Study Start Date :

Jun 10, 2023

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Jun 30, 2024

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Investigate the impact of advanced paternal age on sperm DNA fragmentation [Up to 3 weeks]
Comparing mean sperm DNA fragmentation throughout the chart review of different age groups

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Inclusion Criteria:

Male of at least 18 years of age

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Clinique Ovo	Montreal	Quebec	Canada	H4P 2S4

Sponsors and Collaborators

Clinique Ovo

Investigators

Principal Investigator: Jacques Kadoch, MD, Clinique Ovo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Clinique Ovo

ClinicalTrials.gov Identifier:

NCT05894356

Other Study ID Numbers:

3287

First Posted:

Jun 8, 2023

Last Update Posted:

Jun 8, 2023

Last Verified:

Jun 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Infertility

Infertility, Male

Study Results

No Results Posted as of Jun 8, 2023