Detection Rate of SARS-CoV-2 in Male Genitourinary System and Its Impact on Male Reproductive Health. (COVID-19)

T

Tongji Hospital

Status

Unknown

Conditions

Coronavirus Disease 2019

Treatments

Other: Coronavirus Disease 2019

Study type

Observational

Funder types

Other

Identifiers

NCT04388631
2020-S073

Details and patient eligibility

About

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.

Full 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.

Enrollment

200 estimated patients

Sex

Male

Ages

18 to 60 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

200 participants in 2 patient groups

Exposed group
Description:
Male patient discharged with COVID-19
Treatment:
Other: Coronavirus Disease 2019
Control group
Description:
Healthy male volunteers without COVID-19

Trial contacts and locations

1

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Central trial contact

Tao Wang, M.D

Data sourced from clinicaltrials.gov

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