Assessing the Effect of Abstinence Period on Semen Parameters

NCT05701163 | Withdrawn

• 1 other identifier: 21-10024093
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to learn about the impact of abstinence periods on sperm quality in healthy males 20-45 years of age with no significant comorbidities who are able to produce a semen sample via masturbation. The main question it aims to answer is: • Do shorter abstinence periods result in improved semen quality? Participants will provide semen samples for analysis following abstinence periods of 7 days, 5 days, 2 days, 1 day, and 3 hours.

Conditions

Infertility, Male

Outcome Measures

Primary Outcomes (3)

• Change in semen analysis parameters based on different abstinence periods: volume

  The primary objective is to examine the differences in semen analysis parameters (volume in mL) after varying abstinence periods (7 days, 5 days, 2 days, 1 day, 3 hours).

  7 days, 5 days, 2 days, 1 day, 3 hours

• Change in semen analysis parameters based on different abstinence periods: sperm concentration

  The primary objective is to examine the differences in semen analysis parameters (sperm concentration measured in million sperm/mL) after varying abstinence periods (7 days, 5 days, 2 days, 1 day, 3 hours).

  7 days, 5 days, 2 days, 1 day, 3 hours

• Change in semen analysis parameters based on different abstinence periods: motility

  The primary objective is to examine the differences in semen analysis parameters (motility measured as a percentage) after varying abstinence periods (7 days, 5 days, 2 days, 1 day, 3 hours).

  7 days, 5 days, 2 days, 1 day, 3 hours

Secondary Outcomes (1)

• Change in sperm DNA fragmentation based on different abstinence periods

  7 days, 5 days, 2 days, 1 day, 3 hours

Study Arms (1)

Healthy Volunteers

EXPERIMENTAL

Healthy males with no significant comorbidities, aged 20-45 years who are able to produce a semen sample by masturbation.

Other: Abstinence followed by semen sample collection.

Interventions

Abstinence followed by semen sample collection. OTHER

Abstinence is the intervention. Semen samples will be collected after abstinence periods.

Healthy Volunteers

Eligibility Criteria

• Age: 20 Years - 45 Years
• Gender Eligibility Details: Male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Males, aged 20-45 years
• Healthy, no significant comorbidities
• Able to produce a semen sample by masturbation
• Total sperm count ≥ 1 million sperm
• Abnormal sperm DNA fragmentation (TUNEL assay value ≥ 20%)

You may not qualify if:

• Age \< 20 or \> 45 years
• Significant comorbidities, including significant cardiac, pulmonary, gastrointestinal, hematologic, or neurologic disease
• Total sperm count \< 1 million sperm
• Aspermia (semen volume = 0)
• Normal sperm DNA fragmentation (TUNEL assay value \< 20%)

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Infertility, Male

Condition Hierarchy (Ancestors)

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

Study Officials

• Jonathan Gal, MD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2022
• First Posted: January 27, 2023
• Study Start: April 4, 2023
• Primary Completion (Estimated): February 5, 2028
• Study Completion (Estimated): February 5, 2028
• Last Updated: February 27, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)