Detection Rate of SARS-CoV-2 in Male Genitourinary System and Its Impact on Male Reproductive Health.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Coronavirus Disease 2019

Intervention / Treatment
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* Other: Coronavirus Disease 2019


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Exposed group<br>Male patient discharged with COVID-19 | Other: Coronavirus Disease 2019<br>* male patients who have developed COVID-19<br>|
| Control group<br>Healthy male volunteers without COVID-19 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sperm density | 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. | 3 months | 
| Sperm activity | 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. | 3 months | 
| Erection hardness and duration | Erection hardness and duration will be evaluated during sleep by RigiscanHealth Organization (WHO) normal values based on the WHO 2010 reference limits. | 3 months | 
| IIEF-5/QEQ questionnaire score | IIEF-5/QEQ questionnaire score will be obtained by filling out the questionnaire every visit. | 3 months | 
| Detection rate of SARS-CoV-2 in male genitourinary system | Detection rate of SARS-CoV-2 in male genitourinary system will be evaluated by real time-polymerase chain reaction (RT-PCR). | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Semen volume | Sperm volume will be obtained in the semen sample analysis using the World Health Organization (WHO) normal values based on the WHO 2010 reference limits. | 3 months | 
| Sperm survival rate | Sperm survival rate will be obtained in the semen sample analysis using the World Health Organization (WHO) normal values based on the WHO 2010 reference limits. | 3 months | 
| Serum testosterone/luteinizing hormone (LH)/follicle stimulating hormone (FSH) level | The serum testosterone/LH/FSH levels will be tested in every visit. | 3 months | 
| SCL-90 questionnaire score | SCL-90 questionnaire score will be obtained using SCL-90 questionnaire. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Coronavirus Disease 2019, Male reproductive health, Mental health