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

May 14, 2020 updated by: Jihong Liu, Tongji Hospital

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Tao Wang, M.D
  • Phone Number: 027-83663640
  • Email: tjhwt@126.com

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China
        • Recruiting
        • Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Exposed group
Male patient discharged with COVID-19
Other: Coronavirus Disease 2019
male patients who have developed COVID-19
Control group
Healthy male volunteers without COVID-19

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Sperm density
Time Frame: 3 months
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
Time Frame: 3 months
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
Time Frame: 3 months
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
Time Frame: 3 months
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
Time Frame: 1 month
Detection rate of SARS-CoV-2 in male genitourinary system will be evaluated by real time-polymerase chain reaction (RT-PCR).
1 month

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Semen volume
Time Frame: 3 months
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
Time Frame: 3 months
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
Time Frame: 3 months
The serum testosterone/LH/FSH levels will be tested in every visit.
3 months
SCL-90 questionnaire score
Time Frame: 3 months
SCL-90 questionnaire score will be obtained using SCL-90 questionnaire.
3 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Height
Time Frame: 3 months
Height will be measured at every visit
3 months
Weight
Time Frame: 3 months
Weight will be measured at every visit
3 months
Clinical classification of COVID-19
Time Frame: 1 month
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tongji Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jihong Liu, M.D, Departments of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 10, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 12, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 14, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 18, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020-S073

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De-identified individual participant data for all primary and secondary outcome measure will be available.

IPD Sharing Time Frame

Data will be available with 6 months of study completion.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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