NCT04388631

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

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.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: Male
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Coronavirus Disease 2019

Interventions

Type	Name	Description
OTHER	Coronavirus Disease 2019	male patients who have developed COVID-19

Timeline

• Start date: 2020-05-10
• Primary completion: 2021-05-01
• Completion: 2021-05-01
• First posted: 2020-05-14
• Last updated: 2020-05-18

Locations

1 site across 1 country: China