Clinical trial NCT04388631: Detection Rate of SARS-CoV-2 in Male Genitourinary System and Its Impact on Male Reproductive Health.
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.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronavirus Disease 2019
Keywords: Coronavirus Disease 2019
Male reproductive health
Mental health
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2020-05-14
Enrollment: 200
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: male patients discharged with COVID-19 who have no previous sexual function and fertility related disease.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Sperm density
timeFrame: 3 months
measure: Sperm activity
timeFrame: 3 months
measure: Erection hardness and duration
timeFrame: 3 months
measure: IIEF-5/QEQ questionnaire score
timeFrame: 3 months
measure: Detection rate of SARS-CoV-2 in male genitourinary system
timeFrame: 1 month
Secondary outcomes:
measure: Semen volume
timeFrame: 3 months
measure: Sperm survival rate
timeFrame: 3 months
measure: Serum testosterone/luteinizing hormone (LH)/follicle stimulating hormone (FSH) level
timeFrame: 3 months
measure: SCL-90 questionnaire score
timeFrame: 3 months
Other outcomes:
measure: Height
timeFrame: 3 months
measure: Weight
timeFrame: 3 months
measure: Clinical classification of COVID-19
timeFrame: 1 month
Locations:
city: Wuhan
country: China
facility: Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Departments of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China
name: Jihong Liu, M.D
role: PRINCIPAL_INVESTIGATOR
References:
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