Infertility, MaleNCT06335706
The Influence of Fit of Underpants Worn on Semen Quality
An observational study of Infertility, Male and Semen Analysis, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
The goal of this observational study is to investigate the impact of underpants fit among Thai males attending the Infertility Clinic, whether alone or with their spouses. The main questions it aims to answer are: Assessing the effect of underpants fit on basic semen parameters and sperm DNA integrity. Read more about this study
- Who is it for?
- Ages 20 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, Male, Semen Analysis
- What is being tested?
- Fit of underpants worn
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 120 participants
- Where
- 1 siteThailand
- Study dates
- 28 Mar 2024to 7 Jun 2024
- Phase
- Observational
- 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 55 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: The study aims to enroll approximately 120 participants, comprising Thai male partners who either alone or with spouses visit the Reproductive Biology Unit (Infertility Clinic) at King Chulalongkorn Memorial Hospital.
Who may be able to join
- Male partner, Thai citizen
- Age 20 - 55 years
- Participants able and willing to fill in an informed consent form
- Participants capable of completing questionnaire form
- Semen sample collection after 2-7 days of abstinence
- Participants wearing specific type of underpants not less than 8 hours per day
Who cannot join
- Any congenital factor (e.g. cystic fibrosis, congenital absence of vas deferens, cryptorchidism)
- Any testicular disorder (e.g. varicocele, testicular torsion, testicular trauma)
- Any genital tract disorders/ infections (e.g. prostatitis, epididymitis, urogenital tract obstruction)
- Severe systemic disorder (e.g. liver cirrhosis, renal failure)
- Sexual dysfunction (erectile dysfunction)
- Exogenous factors (chemotherapy, medications, radiation)
- Any surgery comprising vascularization of testis
- Participants wearing both tight and loose-fitted underpants
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this observational study is to investigate the impact of underpants fit among Thai males attending the Infertility Clinic, whether alone or with their spouses. The main questions it aims to answer are:
- Assessing the effect of underpants fit on basic semen parameters and sperm DNA integrity.
- Determining the prevalence of preferred type of underpants worn by Thai males.
The participants will need to provide informed consent, complete a questionnaire consisting of 28 questions, and provide a semen sample.
Read the detailed description
This research aims to investigate the impact of underpants fit on basic semen parameters, with secondary objectives including an examination of its effect on sperm DNA integrity and an assessment of the prevalence of different underpants types among Thai male partners. The study will enroll approximately 120 Thai male partners, aged 20-55 years, attending the Reproductive Biology Unit (Infertility Clinic) at King Chulalongkorn Memorial Hospital in Bangkok, Thailand, either alone or with their spouses. Participants will be required to provide informed consent, complete a 28-question questionnaire, which should take no more than 10 minutes, and undergo semen analysis. The analysis will assess basic semen parameters and sperm DNA integrity, preferably after a 2-7 days abstinence period. The research will be conducted over a single day for each participant.
The data will be divided into two groups based on underpants fit: loosely fitted and tightly fitted. Statistical analysis will be conducted using STATA software version 18, employing regression analysis to assess the independent impact of underpants fit on semen quality. This analysis will control for potential confounding factors such as age, obesity, alcohol and caffeine consumption, cigarette smoking, physical activity, excessive heat exposure, recreational drug use, recent COVID-19 infection, duration of abstinence, previous children, and stress.
This study seeks to build on previous findings, address genital heat stress in Thai male partners, and potentially influence lifestyle changes to reduce male-factor infertility. Future research could explore additional factors such as underwear material and the type of trousers worn by men.
- Conditions
- Infertility, Male, Semen Analysis
- Being tested
- Fit of underpants worn
- Keywords
- Fit of underpants worn, Genital heat stress, Basic semen parameters, Sperm DNA integrity, Thai male partners
- Medical subject headings
- Infertility, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fit of underpants wornBehavioural
Tight or loose-fitted underpants
| Study group | Role | What they receive |
|---|---|---|
| Frequently worn underpants during daytime | It will be divided into two groups based on the type of underwear worn: loose-fit, which includes boxers and tight-fit, which includes all other types. Receives: Behavioral: Fit of underpants worn | |
| Frequently worn underpants at nighttime | It will be divided into two groups based on the type of underwear worn: loose-fit, which includes boxers or none, and tight-fit, which includes all other types. Receives: Behavioral: Fit of underpants worn |
What is being measured
The primary outcome is the main question the study is designed to answer.
Semen Volume
Semen volume will be assessed in milliliters.
Measured: Semen sample will be collected once, on a date advised by the doctor, following a period of ejaculatory abstinence ranging from 2 to 7 days. The sample will be evaluated within 30 minutes of collection.
Total sperm count
The total sperm count will be assessed as the total number of sperm cells in millions in the entire ejaculate.
Measured: Semen sample will be collected once, on a date advised by the doctor, following a period of ejaculatory abstinence ranging from 2 to 7 days. The sample will be evaluated within 30 minutes of collection.
Sperm concentration
Sperm concentration will be quantified as the number of million sperm cells per milliliter.
Measured: Semen sample will be collected once, on a date advised by the doctor, following a period of ejaculatory abstinence ranging from 2 to 7 days. The sample will be evaluated within 30 minutes of collection.
Sperm motility
Sperm motility will be evaluated as the percentage of sperm cells exhibiting movement.
Measured: Semen sample will be collected once, on a date advised by the doctor, following a period of ejaculatory abstinence ranging from 2 to 7 days. The sample will be evaluated within 30 minutes of collection.
Sperm morphology
Sperm morphology will be evaluated as percentage of sperm cells with normal shape.
Measured: Semen sample will be collected once, on a date advised by the doctor, following a period of ejaculatory abstinence ranging from 2 to 7 days. The sample will be evaluated within 30 minutes of collection.
Secondary outcomes (1)
Sperm DNA integrity
Sperm DNA integrity will be evaluated as percentage of abnormal DNA fragmentation (%).
Measured: The leftover semen sample after basic semen analysis will be stored and slides will be prepared. Sperm DNA integrity will be assessed immediately after slide preparation or after freezing the slide for one day, if necessary.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2024
- Study start28 Mar 2024
- Primary completion7 Jun 2024
- Study completion7 Jun 2024
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 Chulalongkorn 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Harnam Kaur, MD, Chulalongkorn University
- Investigators
- Unnop Jaisamrarn, MD, MHS, Study chair, Chulalongkorn UniversityHarnam Kaur, MBBS, Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06335706
- Sponsor's protocol ID
- 0596/66
- Status last verified
- Aug 2024
- First submitted
- 14 Mar 2024
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Fit of Underpants Worn on Semen Quality
- ClinicalTrials.gov ID
- NCT06335706
- Acronym / sponsor ID
- 0596/66
- Conditions
- Infertility, Male, Semen Analysis
- Keywords
- Fit of underpants worn, Genital heat stress, Basic semen parameters, Sperm DNA integrity, Thai male partners
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 28 Mar 2024 (actual)
- Primary completion
- 7 Jun 2024 (actual)
- Study completion
- 7 Jun 2024 (actual)
- First posted
- 28 Mar 2024 (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 observational study is to investigate the impact of underpants fit among Thai males attending the Infertility Clinic, whether alone or with their spouses. The main questions it aims to answer are:
- Assessing the effect of underpants fit on basic semen parameters and sperm DNA integrity.
- Determining the prevalence of preferred type of underpants worn by Thai males.
The participants will need to provide informed consent, complete a questionnaire consisting of 28 questions, and provide a semen sample.
Detailed description
This research aims to investigate the impact of underpants fit on basic semen parameters, with secondary objectives including an examination of its effect on sperm DNA integrity and an assessment of the prevalence of different underpants types among Thai male partners. The study will enroll approximately 120 Thai male partners, aged 20-55 years, attending the Reproductive Biology Unit (Infertility Clinic) at King Chulalongkorn Memorial Hospital in Bangkok, Thailand, either alone or with their spouses. Participants will be required to provide informed consent, complete a 28-question questionnaire, which should take no more than 10 minutes, and undergo semen analysis. The analysis will assess basic semen parameters and sperm DNA integrity, preferably after a 2-7 days abstinence period. The research will be conducted over a single day for each participant.
The data will be divided into two groups based on underpants fit: loosely fitted and tightly fitted. Statistical analysis will be conducted using STATA software version 18, employing regression analysis to assess the independent impact of underpants fit on semen quality. This analysis will control for potential confounding factors such as age, obesity, alcohol and caffeine consumption, cigarette smoking, physical activity, excessive heat exposure, recreational drug use, recent COVID-19 infection, duration of abstinence, previous children, and stress.
This study seeks to build on previous findings, address genital heat stress in Thai male partners, and potentially influence lifestyle changes to reduce male-factor infertility. Future research could explore additional factors such as underwear material and the type of trousers worn by men.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Frequently worn underpants during daytime | – | Behavioral: Fit of underpants wornIt will be divided into two groups based on the type of underwear worn: loose-fit, which includes boxers and tight-fit, which includes all other types. |
| Frequently worn underpants at nighttime | – | Behavioral: Fit of underpants wornIt will be divided into two groups based on the type of underwear worn: loose-fit, which includes boxers or none, and tight-fit, which includes all other types. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The study aims to enroll approximately 120 participants, comprising Thai male partners who either alone or with spouses visit the Reproductive Biology Unit (Infertility Clinic) at King Chulalongkorn Memorial Hospital.
Key inclusion criteria (6 listed)
- Male partner, Thai citizen
- Age 20 - 55 years
- Participants able and willing to fill in an informed consent form
- Participants capable of completing questionnaire form
- Semen sample collection after 2-7 days of abstinence
Key exclusion criteria (8 listed)
- Any congenital factor (e.g. cystic fibrosis, congenital absence of vas deferens, cryptorchidism)
- Any testicular disorder (e.g. varicocele, testicular torsion, testicular trauma)
- Any genital tract disorders/ infections (e.g. prostatitis, epididymitis, urogenital tract obstruction)
- Severe systemic disorder (e.g. liver cirrhosis, renal failure)
- Sexual dysfunction (erectile dysfunction)
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 |
|---|---|---|
| Fit of underpants wornTight or loose-fitted underpants | Behavioural | Frequently worn underpants at nighttime, Frequently worn underpants during daytime |
Primary outcome
Semen Volume
Time frame: Semen sample will be collected once, on a date advised by the doctor, following a period of ejaculatory abstinence ranging from 2 to 7 days. The sample will be evaluated within 30 minutes of collection.
Semen volume will be assessed in milliliters.
Total sperm count
Time frame: Semen sample will be collected once, on a date advised by the doctor, following a period of ejaculatory abstinence ranging from 2 to 7 days. The sample will be evaluated within 30 minutes of collection.
The total sperm count will be assessed as the total number of sperm cells in millions in the entire ejaculate.
Sperm concentration
Time frame: Semen sample will be collected once, on a date advised by the doctor, following a period of ejaculatory abstinence ranging from 2 to 7 days. The sample will be evaluated within 30 minutes of collection.
Sperm concentration will be quantified as the number of million sperm cells per milliliter.
Sperm motility
Time frame: Semen sample will be collected once, on a date advised by the doctor, following a period of ejaculatory abstinence ranging from 2 to 7 days. The sample will be evaluated within 30 minutes of collection.
Sperm motility will be evaluated as the percentage of sperm cells exhibiting movement.
Sperm morphology
Time frame: Semen sample will be collected once, on a date advised by the doctor, following a period of ejaculatory abstinence ranging from 2 to 7 days. The sample will be evaluated within 30 minutes of collection.
Sperm morphology will be evaluated as percentage of sperm cells with normal shape.
1 secondary outcome
Sperm DNA integrity
Time frame: The leftover semen sample after basic semen analysis will be stored and slides will be prepared. Sperm DNA integrity will be assessed immediately after slide preparation or after freezing the slide for one day, if necessary.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- Individual participant dataSharing planned: Undecided
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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.
Unnop Jaisamrarn, MD, MHS study chair
Chulalongkorn University
Harnam Kaur, MBBS principal investigator
Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, Male and Semen Analysis, run by Chulalongkorn University at 1 site in Thailand.
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 6 inclusion and 8 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: finished, as of the sponsor's last update on 26 Aug 2024. 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 Thailand. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Semen Volume (time frame: Semen sample will be collected once, on a date advised by the doctor, following a period of ejaculatory abstinence ranging from 2 to 7 days. The sample will be evaluated within 30 minutes of collection.). The study lists 5 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 26 Aug 2024.