Assessing the Effect of Abstinence Period on Semen Parameters

February 25, 2025 updated by: Weill Medical College of Cornell University

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Withdrawn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

Intervention / Treatment

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

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

Study Locations

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

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

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

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

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

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
Time Frame: 7 days, 5 days, 2 days, 1 day, 3 hours
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
Time Frame: 7 days, 5 days, 2 days, 1 day, 3 hours
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
Time Frame: 7 days, 5 days, 2 days, 1 day, 3 hours
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
Time Frame: 7 days, 5 days, 2 days, 1 day, 3 hours
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

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

Sponsor

Weill Medical College of Cornell University

Investigators

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

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)

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

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

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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