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Prospective Two-arm Study of Fertility in Men With COVID-19

NCT04716179 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2021-07-22

No results posted yet for this study

Summary

COVID-19 infection is hypothesized to have a potentially negative effect on male fertility through direct damage to the testes. The current trial is aimed at investigating the effect of SARS-CoV-2 on fertility and determining if viral bodies are capable of directly damaging testicular cells

Conditions

  • Covid19
  • Fertility Issues

Interventions

DIAGNOSTIC_TEST

Sperm test

The semen sample will be collected and analyzed within an hour after collection.

DIAGNOSTIC_TEST

hormone levels (testosterone, FSH, LH, prolactin)

Hormone levels (testosterone, FSH, LH, prolactin) will be assessed on 5-7 days after symptom onset until the end of hospital stay.

DIAGNOSTIC_TEST

SARS-CoV-2 Ig G levels

SARS-CoV-2 Ig G levels will be assessed on 3 months after discharge

OTHER

Testis pathology samples

Postmortem examination of the testes of patients deceased as a result of COVID-19 infection will be carried out using immunohistochemistry analysis.

Sponsors & Collaborators

  • I.M. Sechenov First Moscow State Medical University

    lead OTHER

Principal Investigators

  • Dmitry Enikeev, M.D. · Sechenov University

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-01-18
Primary Completion
2021-05-18
Completion
2021-08-31

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04716179 on ClinicalTrials.gov