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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exposed group | Male patient discharged with COVID-19 |
| |
| Control group | Healthy male volunteers without COVID-19 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coronavirus Disease 2019 | Other | male patients who have developed COVID-19 |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Height | Height will be measured at every visit | 3 months |
| Weight | Weight will be measured at every visit | 3 months |
Inclusion Criteria:
Exclusion Criteria:
all participants are male
male patients discharged with COVID-19 who have no previous sexual function and fertility related disease.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tao Wang, M.D | Contact | 027-83663640 | tjhwt@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Jihong Liu, M.D | Departments of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32142651 | Background | Hoffmann M, Kleine-Weber H, Schroeder S, Kruger N, Herrler T, Erichsen S, Schiergens TS, Herrler G, Wu NH, Nitsche A, Muller MA, Drosten C, Pohlmann 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. | |
| 15231706 |
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De-identified individual participant data for all primary and secondary outcome measure will be available.
Data will be available with 6 months of study completion.
Data access requests will be reviewed by the external independent review panel and Tongji hospital. Requester will be required to sign a Data Access Agreement.
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D000092862 | Psychological Well-Being |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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whole blood,serum,urine, prostate fluid, and semen
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 |
| 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 |
| 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. doi: 10.1210/en.2004-0443. Epub 2004 Jul 1. |
| 16237152 | Background | 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. doi: 10.1095/biolreprod.105.044776. Epub 2005 Oct 19. |
| 25411084 | Background | 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. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D010549 | Personal Satisfaction |
| D001519 | Behavior |