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Completed

NCT Number: NCT06335706

The Influence of Fit of Underpants Worn on Semen Quality

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.

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Key information

Age range

20 year–55 year

Sex eligibility

Male

Study type

Observational

Primary location

Chulalongkorn University

Bangkok, 10330, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fit of underpants worn

Behavioral

Tight or loose-fitted underpants

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Secondary outcomes

  1. 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 (%).

Other outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 28, 2024
Registry last updated
Aug 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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