The Influence of Fit of Underpants Worn on Semen Quality

Infertility, Male Clinical Trial

Official title:

The Influence of Fit of Underpants Worn on Semen Quality

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06335706
• Other study ID #: 0596/66
• Status: Not yet recruiting
• Start date: March 2024
• Est. completion date: May 2024

Study information

• Verified date: March 2024
• Source: Chulalongkorn University
• Contact: Harnam Kaur, MBBS
• Phone: +66 99-096-1012
• Email: harnamkaur1310[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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. - 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 55 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Infertility
• Infertility, Male

Intervention

Behavioral:
• Fit of underpants worn
Tight or loose-fitted underpants

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Preferred type of underpants	It will be evaluated as the percentage of participants who predominantly wear different types of underwear.	The analysis will commence upon completion of the anticipated data collection period of 3-months.
Primary	Semen Volume	Semen volume will be assessed in milliliters.	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.
Primary	Total sperm count	The total sperm count will be assessed as the total number of sperm cells in millions in the entire ejaculate.	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.
Primary	Sperm concentration	Sperm concentration will be quantified as the number of million sperm cells per milliliter.	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.
Primary	Sperm motility	Sperm motility will be evaluated as the percentage of sperm cells exhibiting movement.	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.
Primary	Sperm morphology	Sperm morphology will be evaluated as percentage of sperm cells with normal shape.	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	Sperm DNA integrity	Sperm DNA integrity will be evaluated as percentage of abnormal DNA fragmentation (%).	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.