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

Coronavirus Disease 2019 Clinical Trial

— COVID-19  

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04388631
• Other study ID #: 2020-S073
• Status: Recruiting
• Start date: May 10, 2020
• Est. completion date: May 1, 2021

Study information

• Verified date: May 2020
• Source: Tongji Hospital
• Contact: Tao Wang, M.D
• Phone: 027-83663640
• Email: tjhwt[@]126.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 1, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Coronavirus Disease 2019
• Coronavirus Infections

Intervention

Other:
• Coronavirus Disease 2019
male patients who have developed COVID-19

Locations

Country	Name	City	State
China	Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Tongji Hospital

Country where clinical trial is conducted

China, 

References & Publications (4)

Douglas GC, O'Bryan MK, Hedger MP, Lee DK, Yarski MA, Smith AI, Lew RA. The novel angiotensin-converting enzyme (ACE) homolog, ACE2, is selectively expressed by adult Leydig cells of the testis. Endocrinology. 2004 Oct;145(10):4703-11. Epub 2004 Jul 1. — View Citation

Fraga-Silva RA, Costa-Fraga FP, Montecucco F, Sturny M, Faye Y, Mach F, Pelli G, Shenoy V, da Silva RF, Raizada MK, Santos RA, Stergiopulos N. Diminazene protects corpus cavernosum against hypercholesterolemia-induced injury. J Sex Med. 2015 Feb;12(2):289-302. doi: 10.1111/jsm.12757. Epub 2014 Nov 20. — View Citation

Hoffmann M, Kleine-Weber H, Schroeder S, Krüger N, Herrler T, Erichsen S, Schiergens TS, Herrler G, Wu NH, Nitsche A, Müller MA, Drosten C, Pöhlmann S. SARS-CoV-2 Cell Entry Depends on ACE2 and TMPRSS2 and Is Blocked by a Clinically Proven Protease Inhibitor. Cell. 2020 Apr 16;181(2):271-280.e8. doi: 10.1016/j.cell.2020.02.052. Epub 2020 Mar 5. — View Citation

Xu J, Qi L, Chi X, Yang J, Wei X, Gong E, Peh S, Gu J. Orchitis: a complication of severe acute respiratory syndrome (SARS). Biol Reprod. 2006 Feb;74(2):410-6. Epub 2005 Oct 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Height	Height will be measured at every visit	3 months
Other	Weight	Weight will be measured at every visit	3 months
Other	Clinical classification of COVID-19	Clinical classification of COVID-19 will be determined according to the New Coronavirus Pneumonia Prevention and Control Program (7th edition) published by the National Health Commission of China	1 month
Primary	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
Primary	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
Primary	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
Primary	IIEF-5/QEQ questionnaire score	IIEF-5/QEQ questionnaire score will be obtained by filling out the questionnaire every visit.	3 months
Primary	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	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
Secondary	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
Secondary	Serum testosterone/luteinizing hormone (LH)/follicle stimulating hormone (FSH) level	The serum testosterone/LH/FSH levels will be tested in every visit.	3 months
Secondary	SCL-90 questionnaire score	SCL-90 questionnaire score will be obtained using SCL-90 questionnaire.	3 months