Assessing the Effect of Abstinence Period on Semen Parameters
Primary Purpose
Infertility, Male
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Abstinence followed by semen sample collection.
Sponsored by
About this trial
This is an interventional other trial for Infertility, Male
Eligibility Criteria
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%)
Sites / Locations
- Weill Cornell MedicineRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Healthy Volunteers
Arm Description
Healthy males with no significant comorbidities, aged 20-45 years who are able to produce a semen sample by masturbation.
Outcomes
Primary Outcome Measures
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).
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).
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).
Secondary Outcome Measures
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).
Full Information
NCT ID
NCT05701163
First Posted
December 23, 2022
Last Updated
April 18, 2023
Sponsor
Weill Medical College of Cornell University
1. Study Identification
Unique Protocol Identification Number
NCT05701163
Brief Title
Assessing the Effect of Abstinence Period on Semen Parameters
Official Title
Assessing the Effect of Abstinence Period on Semen Parameters
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 4, 2023 (Actual)
Primary Completion Date
February 2027 (Anticipated)
Study Completion Date
February 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Weill Medical College of Cornell University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Male
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Healthy Volunteers
Arm Type
Experimental
Arm Description
Healthy males with no significant comorbidities, aged 20-45 years who are able to produce a semen sample by masturbation.
Intervention Type
Other
Intervention Name(s)
Abstinence followed by semen sample collection.
Intervention Description
Abstinence is the intervention. Semen samples will be collected after abstinence periods.
Primary Outcome Measure Information:
Title
Change in semen analysis parameters based on different abstinence periods: volume
Description
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).
Time Frame
7 days, 5 days, 2 days, 1 day, 3 hours
Title
Change in semen analysis parameters based on different abstinence periods: sperm concentration
Description
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).
Time Frame
7 days, 5 days, 2 days, 1 day, 3 hours
Title
Change in semen analysis parameters based on different abstinence periods: motility
Description
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).
Time Frame
7 days, 5 days, 2 days, 1 day, 3 hours
Secondary Outcome Measure Information:
Title
Change in sperm DNA fragmentation based on different abstinence periods
Description
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).
Time Frame
7 days, 5 days, 2 days, 1 day, 3 hours
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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%)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Grace Tan, MA
Phone
2127463208
Email
grt2008@med.cornell.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Akeem Noziere
Phone
2127464745
Email
akn4001@med.cornell.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Gal, MD
Organizational Affiliation
Weill Medical College of Cornell University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weill Cornell Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grace Tan, MA
Phone
212-746-3208
Email
grt2008@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Jonathan Gal, MD
Phone
2127463208
Email
jog4018@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Jonathan Gal, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Assessing the Effect of Abstinence Period on Semen Parameters
We'll reach out to this number within 24 hrs