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临床试验/NCT06335706
NCT06335706已完成不适用

The Influence of Fit of Underpants Worn on Semen Quality

Chulalongkorn University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年3月28日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
120
试验地点
1
主要终点
Sperm morphology

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
20 Years 至 55 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Sperm morphology

时间窗: 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 Volume

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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.

次要结局

  • 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.)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Harnam Kaur, MD

Principal Investigator

Chulalongkorn University

研究点 (1)

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