The Influence of Fit of Underpants Worn on Semen Quality

NCT06335706 | Completed

• 1 other identifier: 0596/66
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infertility, Male; Semen Analysis

Keywords

Fit of underpants worn; Genital heat stress; Basic semen parameters; Sperm DNA integrity; Thai male partners

Outcome Measures

Primary Outcomes (5)

• 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.

• 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.

• 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.

• 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.

• 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 Outcomes (1)

• Sperm DNA integrity

  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 Outcomes (1)

• Preferred type of underpants

  The analysis will commence upon completion of the anticipated data collection period of 3-months.

Study Arms (2)

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

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

Interventions

Fit of underpants worn BEHAVIORAL

Tight or loose-fitted underpants

Frequently worn underpants at nighttime; Frequently worn underpants during daytime

Eligibility Criteria

• Age: 20 Years - 55 Years
• Gender Eligibility Details: Gender: Male Eligibility Criteria: Male individuals, aged 20-55 years, and citizens of Thailand.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

Chulalongkorn University

Bangkok, 10330, Thailand

Location

MeSH Terms

Conditions

Infertility, Male

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Study Officials

• Unnop Jaisamrarn, MD, MHS

  Chulalongkorn University

  STUDY CHAIR

• Harnam Kaur, MBBS

  Chulalongkorn University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: March 28, 2024
• Study Start: March 28, 2024
• Primary Completion: June 7, 2024
• Study Completion: June 7, 2024
• Last Updated: August 26, 2024

Record last verified: 2024-08

Locations

TH (1)