Assessing the Effect of Abstinence Period on Semen Parameters

Infertility, Male Clinical Trial

Official title:

Assessing the Effect of Abstinence Period on Semen Parameters

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05701163
• Other study ID #: 21-10024093
• Status: Recruiting
• Phase: N/A
• Start date: April 4, 2023
• Est. completion date: February 2028

Study information

• Verified date: March 2024
• Source: Weill Medical College of Cornell University
• Contact: Grace Tan, MA
• Phone: 2127463208
• Email: grt2008[@]med.cornell.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 2028
• Est. primary completion date: February 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 45 Years

Eligibility

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%)

Related Conditions & MeSH terms

• Infertility
• Infertility, Male

Intervention

Other:
• Abstinence followed by semen sample collection.
Abstinence is the intervention. Semen samples will be collected after abstinence periods.

Locations

Country	Name	City	State
United States	Weill Cornell Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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