Assessing the Effect of Abstinence Period on Semen Parameters

Weill Cornell Medicine (WCM)

Status: Withdrawn

Conditions: Infertility, Male

Treatments: Other: Abstinence followed by semen sample collection.

Study type: Interventional

Funder types: Other

Identifiers

NCT05701163

21-10024093

Details and patient eligibility

About

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.

Full 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).

Sex: Male

Ages: 20 to 45 years old

Volunteers: Accepts Healthy Volunteers

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%)

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Healthy Volunteers

Experimental group

Description:

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

Treatment:

Other: Abstinence followed by semen sample collection.