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

NCT04388631 | Unknown

• 1 other identifier: 2020-S073
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronavirus Disease 2019

Keywords

Coronavirus Disease 2019; Male reproductive health; Mental health

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (4)

• Semen volume

  3 months

• Sperm survival rate

  3 months

• Serum testosterone/luteinizing hormone (LH)/follicle stimulating hormone (FSH) level

  3 months

• SCL-90 questionnaire score

  3 months

Other Outcomes (3)

• Height

  3 months

• Weight

  3 months

• Clinical classification of COVID-19

  1 month

Study Arms (2)

Exposed group

Male patient discharged with COVID-19

Other: Coronavirus Disease 2019

Control group

Healthy male volunteers without COVID-19

Interventions

Coronavirus Disease 2019 OTHER

male patients who have developed COVID-19

Exposed group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Gender Eligibility Details: all participants are male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

male patients discharged with COVID-19 who have no previous sexual function and fertility related disease.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

RECRUITING

Related Publications (4)

• 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.

  PMID: 32142651 BACKGROUND

• 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.

  PMID: 15231706 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.

  PMID: 16237152 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.

  PMID: 25411084 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

whole blood，serum，urine, prostate fluid, and semen

MeSH Terms

Conditions

COVID-19; Psychological Well-Being

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Personal Satisfaction; Behavior

Study Officials

• Jihong Liu, M.D

  Departments of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tao Wang, M.D

CONTACT

027-83663640; tjhwt@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: May 12, 2020
• First Posted: May 14, 2020
• Study Start: May 10, 2020
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2021
• Last Updated: May 18, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data will be available with 6 months of study completion.
• Access Criteria: 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.

Locations

CN (1)