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

NCT ID: NCT04388631

Last Updated: 2020-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-10

Study Completion Date

2021-05-01

Brief Summary

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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.

Detailed Description

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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

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Coronavirus Disease 2019

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Exposed group

Male patient discharged with COVID-19

Coronavirus Disease 2019

Intervention Type OTHER

male patients who have developed COVID-19

Control group

Healthy male volunteers without COVID-19

No interventions assigned to this group

Interventions

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Coronavirus Disease 2019

male patients who have developed COVID-19

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Tongji Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jihong Liu

Principal Investigator, Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jihong Liu, M.D

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Wuhan, Hubei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Tao Wang, M.D

Role: CONTACT

027-83663640

Facility Contacts

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Tao Wang, M.D

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 32142651 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15231706 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16237152 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25411084 (View on PubMed)

Other Identifiers

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2020-S073

Identifier Type: -

Identifier Source: org_study_id

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