Assessing the Effect of Abstinence Period on Semen Parameters

Study Overview
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Brief Summary
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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
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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).

Official Title
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Assessing the Effect of Abstinence Period on Semen Parameters

Conditions
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Infertility, Male

Intervention / Treatment
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* Other: Abstinence followed by semen sample collection.


Participation Criteria
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Eligibility Criteria
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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%)

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy Volunteers<br>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.<br>* Abstinence is the intervention. Semen samples will be collected after abstinence periods.<br>|

What is the study measuring?
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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 |