Infertility, Male
Conditions
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).
Interventions
OTHERAbstinence followed by semen sample collection.
Abstinence is the intervention. Semen samples will be collected after abstinence periods.
Sponsors
Weill Medical College of Cornell University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
20 Years to 45 Years
Healthy volunteers
Yes
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%)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
United States
Outcome results
None listed