Assessing the Effect of Abstinence Period on Semen Parameters

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-04

Study Completion Date

2028-02-05

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.

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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).

Conditions

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Infertility, Male

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Healthy Volunteers

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

Group Type EXPERIMENTAL

Abstinence followed by semen sample collection.

Intervention Type OTHER

Abstinence is the intervention. Semen samples will be collected after abstinence periods.

Interventions

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Abstinence followed by semen sample collection.

Abstinence is the intervention. Semen samples will be collected after abstinence periods.

Intervention Type OTHER

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%)

Minimum Eligible Age

20 Years

Maximum Eligible Age

45 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes