Infertility, MaleNCT05701163
Assessing the Effect of Abstinence Period on Semen Parameters
A study testing Abstinence followed by semen sample collection. in people with Infertility, Male, run by Weill Medical College of Cornell University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Male
- What is being tested?
- Abstinence followed by semen sample collection.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Apr 2023to 5 Feb 2028
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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%)
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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.
Read the 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).
- Conditions
- Infertility, Male
- Being tested
- Abstinence followed by semen sample collection.
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Abstinence followed by semen sample collection.Other
Abstinence is the intervention. Semen samples will be collected after abstinence periods.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteers | Experimental | Healthy males with no significant comorbidities, aged 20-45 years who are able to produce a semen sample by masturbation. Receives: Other: Abstinence followed by semen sample collection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 7 days, 5 days, 2 days, 1 day, 3 hours
Secondary outcomes (1)
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).
Measured: 7 days, 5 days, 2 days, 1 day, 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2023
- Study start4 Apr 2023
- Primary completion5 Feb 2028 (estimated)
- Study completion5 Feb 2028 (estimated)
Why it stopped: There is no funds available for the study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infertility, MaleStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jonathan Gal, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05701163
- Sponsor's protocol ID
- 21-10024093
- Status last verified
- Feb 2025
- First submitted
- 23 Dec 2022
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Effect of Abstinence Period on Semen Parameters
- ClinicalTrials.gov ID
- NCT05701163
- Acronym / sponsor ID
- 21-10024093
- Conditions
- Infertility, Male
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: There is no funds available for the study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Study start
- 4 Apr 2023 (actual)
- Primary completion
- 5 Feb 2028 (estimated)
- Study completion
- 5 Feb 2028 (estimated)
- First posted
- 27 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteers | Experimental | Other: Abstinence followed by semen sample collection.Healthy males with no significant comorbidities, aged 20-45 years who are able to produce a semen sample by masturbation. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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%)
Key exclusion criteria (5 listed)
- 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%)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Abstinence followed by semen sample collection.Abstinence is the intervention. Semen samples will be collected after abstinence periods. | Other | Healthy Volunteers |
Primary outcome
Change in semen analysis parameters based on different abstinence periods: volume
Time frame: 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
Time frame: 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
Time frame: 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).
1 secondary outcome
Change in sperm DNA fragmentation based on different abstinence periods
Time frame: 7 days, 5 days, 2 days, 1 day, 3 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Gal, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Abstinence followed by semen sample collection. in people with Infertility, Male, run by Weill Medical College of Cornell University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in semen analysis parameters based on different abstinence periods: volume (time frame: 7 days, 5 days, 2 days, 1 day, 3 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.