The Influence of Fit of Underpants Worn on Semen Quality

August 22, 2024 updated by: Harnam Kaur, MD, Chulalongkorn University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10330
        • Chulalongkorn University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Behavioral: Fit of underpants worn
Tight or loose-fitted underpants
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.
Behavioral: Fit of underpants worn
Tight or loose-fitted underpants

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
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
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.
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
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.
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
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Preferred type of underpants
Time Frame: The analysis will commence upon completion of the anticipated data collection period of 3-months.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Investigators

  • Principal Investigator: Harnam Kaur, MBBS, Chulalongkorn University
  • Study Chair: Unnop Jaisamrarn, MD, MHS, Chulalongkorn University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2024

Primary Completion (Actual)

June 7, 2024

Study Completion (Actual)

June 7, 2024

Study Registration Dates

First Submitted

March 14, 2024

First Submitted That Met QC Criteria

March 21, 2024

First Posted (Actual)

March 28, 2024

Study Record Updates

Last Update Posted (Actual)

August 26, 2024

Last Update Submitted That Met QC Criteria

August 22, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0596/66

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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