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

• Conditions: Coronavirus Disease 2019
• Interventions: Other: Coronavirus Disease 2019

• Registration Number: NCT04388631
• Lead Sponsor: Tongji Hospital

Brief 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.

Study Timeline

• Status Verified: 2020-05
• Study Start: 2020-05-10
• Study First Submitted: 2020-05-12
• Study First Submitted QC: 2020-05-12
• Study First Posted: 2020-05-14
• Last Update Submitted: 2020-05-14
• Last Update Posted: 2020-05-18
• Primary Completion: 2021-05-01
• Study Completion: 2021-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 200

Inclusion Criteria

1. Age≥ 18, ≤ 60 years old;
2. Have a fixed sex partner and regular sex life;
3. No previous infectious diseases, chronic diseases, tumor history, and male sexual function and fertility diseases;
4. Normal erectile function, IIEF-5 score> 21 points;
5. Have complete clinical information and contact information；
6. Understand and sign the informed consent form.

Exclusion Criteria

1. Hypertension, diabetes, coronary heart disease, hyperlipidemia and other chronic diseases；
2. Past history of endocrine diseases such as hypopituitarism, hypogonadism, abnormal thyroid function, etc;
3. Past history of mumps virus infection;
4. Past history of bladder cancer, prostate cancer, brain spine injury, testicular injury, pelvic fracture, urethral injury and history of surgical treatment;
5. Severe cardiovascular and cerebrovascular diseases, severe lung diseases, severe hepatitis;
6. Past psychological or mental illness;
7. Contact information not available.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Exposed group	Coronavirus Disease 2019	Male patient discharged with COVID-19

Primary Outcome Measures

Name	Time	Method
Sperm activity	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	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	3 months	IIEF-5/QEQ questionnaire score will be obtained by filling out the questionnaire every visit.
Sperm density	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	3 months	Erection hardness and duration will be evaluated during sleep by RigiscanHealth Organization (WHO) normal values based on the WHO 2010 reference limits.

Secondary Outcome Measures

Name	Time	Method
Sperm survival rate	3 months	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.
SCL-90 questionnaire score	3 months	SCL-90 questionnaire score will be obtained using SCL-90 questionnaire.
Semen volume	3 months	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.
Serum testosterone/luteinizing hormone (LH)/follicle stimulating hormone (FSH) level	3 months	The serum testosterone/LH/FSH levels will be tested in every visit.

Trial Locations

Locations (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology; 🇨🇳 Wuhan, Hubei, China