Assessing the Effect of Abstinence Period on Semen Parameters

Not Applicable

Withdrawn

• Conditions: Infertility, Male
• Interventions: Other: Abstinence followed by semen sample collection.

• Registration Number: NCT05701163
• Lead Sponsor: Weill Medical College of Cornell University

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.

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 Timeline

• Study First Submitted: 2022-12-23
• Study First Submitted QC: 2023-01-17
• Study First Posted: 2023-01-27
• Study Start: 2023-04-04
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-25
• Last Update Posted: 2025-02-27
• Primary Completion: 2028-02-05
• Study Completion: 2028-02-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: Male
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy Volunteers	Abstinence followed by semen sample collection.	Healthy males with no significant comorbidities, aged 20-45 years who are able to produce a semen sample by masturbation.

Primary Outcome Measures

Name	Time	Method
Change in semen analysis parameters based on different abstinence periods: sperm concentration	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).
Change in semen analysis parameters based on different abstinence periods: motility	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).
Change in semen analysis parameters based on different abstinence periods: volume	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).

Secondary Outcome Measures

Name	Time	Method
Change in sperm DNA fragmentation based on different abstinence periods	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).

Trial Locations

Locations (1)

Weill Cornell Medicine; 🇺🇸 New York, New York, United States