Assessing the Effect of Abstinence Period on Semen Parameters

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.

Study Overview

• Status: Withdrawn
• Conditions: Infertility, Male
• Intervention / Treatment: Other: Abstinence followed by semen sample collection.

Detailed Description

Participant Duration: Total length of time on study per subject is 14 days (including 5 days of visit required for sample production). Subjects do not need to complete the visits in order but need to document abstinence period prior to sample production. No follow up will be needed after the study.

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

Secondary Objectives: The secondary objective(s) is to assess changes in sperm DNA fragmentation after varying abstinence periods (7 days, 5 days, 2 days, 1 day, 3 hours).

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Weill Cornell Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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%)

Exclusion Criteria:

• 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%)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healthy Volunteers; 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.; Abstinence is the intervention. Semen samples will be collected after abstinence periods.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in sperm DNA fragmentation based on different abstinence periods	The secondary objective(s) is to assess changes in sperm DNA fragmentation after varying abstinence periods (7 days, 5 days, 2 days, 1 day, 3 hours).	7 days, 5 days, 2 days, 1 day, 3 hours

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Investigators: Principal Investigator: Jonathan Gal, MD, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2023
• Primary Completion (Estimated): February 5, 2028
• Study Completion (Estimated): February 5, 2028

Study Registration Dates

• First Submitted: December 23, 2022
• First Submitted That Met QC Criteria: January 17, 2023
• First Posted (Actual): January 27, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 25, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Male Urogenital Diseases; Infertility; Infertility, Male
• Other Study ID Numbers: 21-10024093

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