Detection Rate of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in Male Genitourinary System and Its Impact on Male Reproductive Health: an Observational Clinical Study.
试验速览
- 阶段
- 不适用
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Sperm activity
研究概览
简要总结
This study will evaluate the changes in sexual function, reproductive function and mental health of male patients discharged from the hospital with COVID-19, and the impact of SARS-CoV-2 on male reproductive health and mental health compared with healthy people during the same period. In addition, men's semen examination reports before and after the new coronavirus pneumonia event will be collected and compared to assess the impact of the event on the quality of men's semen. Also, This study will test the SARS-CoV-2 nucleic acid of the urogenital system of male patients discharged with COVID-19 to provide evidence for the effect of the new coronavirus on the male reproductive system.
详细描述
This study will test SARS-CoV-2 nucleic acids in urine, prostate fluid, and semen of participants with COVID-19 at the first follow-up. All participants will be followed up for 1 year. During follow-up, International Index of Erectile Function-5 (IIEF-5), Quality Evaluation Questionnaire (QEQ), symptom list chart-90 (SCL-90) questionnaire evaluation and sexual function related examinations (including nocturnal penile tumescence, color duplex ultrasonography, etc. ) and fertility-related examinations (including sex hormones, semen routine examinations, etc.) will be performed to assess the changes in male sexual function, reproductive function and mental health of male patients discharged with COVID-19, and the impact of SARS-CoV-2 on male reproductive and mental health. In addition, collect male semen examination reports from April to December in 2017-2020 to evaluate the impact of new coronavirus pneumonia incidents on male semen quality.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Age≥ 18, ≤ 60 years old;
- •Have a fixed sex partner and regular sex life;
- •No previous infectious diseases, chronic diseases, tumor history, and male sexual function and fertility diseases;
- •Normal erectile function, IIEF-5 score> 21 points;
- •Have complete clinical information and contact information；
- •Understand and sign the informed consent form.
排除标准
- •Hypertension, diabetes, coronary heart disease, hyperlipidemia and other chronic diseases；
- •Past history of endocrine diseases such as hypopituitarism, hypogonadism, abnormal thyroid function, etc;
- •Past history of mumps virus infection;
- •Past history of bladder cancer, prostate cancer, brain spine injury, testicular injury, pelvic fracture, urethral injury and history of surgical treatment;
- •Severe cardiovascular and cerebrovascular diseases, severe lung diseases, severe hepatitis;
- •Past psychological or mental illness;
- •Contact information not available.
结局指标
主要结局
Sperm activity
时间窗: 3 months
Sperm activity will be obtained in the semen sample analysis using the World Health Organization (WHO) normal values based on the WHO 2010 reference limits.
Detection rate of SARS-CoV-2 in male genitourinary system
时间窗: 1 month
Detection rate of SARS-CoV-2 in male genitourinary system will be evaluated by real time-polymerase chain reaction (RT-PCR).
IIEF-5/QEQ questionnaire score
时间窗: 3 months
IIEF-5/QEQ questionnaire score will be obtained by filling out the questionnaire every visit.
Sperm density
时间窗: 3 months
Sperm density will be obtained in the semen sample analysis using the World Health Organization (WHO) normal values based on the WHO 2010 reference limits.
Erection hardness and duration
时间窗: 3 months
Erection hardness and duration will be evaluated during sleep by RigiscanHealth Organization (WHO) normal values based on the WHO 2010 reference limits.
次要结局
- Sperm survival rate(3 months)
- SCL-90 questionnaire score(3 months)
- Semen volume(3 months)
- Serum testosterone/luteinizing hormone (LH)/follicle stimulating hormone (FSH) level(3 months)
研究者
Jihong Liu
Principal Investigator, Clinical Professor
Tongji Hospital