NCT04716179

Brief 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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
88

participants targeted

Target at P25-P50 for not_applicable covid19

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

January 18, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 20, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 18, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

July 22, 2021

Status Verified

July 1, 2021

Enrollment Period

4 months

First QC Date

January 17, 2021

Last Update Submit

July 21, 2021

Conditions

Covid19Fertility Issues

Outcome Measures

Primary Outcomes (3)

  • Semen quality analysis - motility

    motility of spermatozoa

    3 months

  • Semen quantity analysis

    count of spermatozoa

    3 months

  • Semen quality analysis - shape

    shape of spermatozoa

    3 months

Secondary Outcomes (5)

  • Testosterone

    3 months

  • FSH

    3 months

  • LH

    3 months

  • Prolactin

    3 months

  • Damage of the testes on pathology

    3 months

Study Arms (2)

Patients with COVID-19

EXPERIMENTAL

Patients with confirmed COVID-19 infection

Diagnostic Test: Sperm testDiagnostic Test: hormone levels (testosterone, FSH, LH, prolactin)Diagnostic Test: SARS-CoV-2 Ig G levelsOther: Testis pathology samples

Healthy participants

OTHER

The controlled group with healthy participants without COVID-19 infection.

Diagnostic Test: Sperm testDiagnostic Test: hormone levels (testosterone, FSH, LH, prolactin)Diagnostic Test: SARS-CoV-2 Ig G levels

Interventions

Sperm testDIAGNOSTIC_TEST

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

Healthy participantsPatients with COVID-19
hormone levels (testosterone, FSH, LH, prolactin)DIAGNOSTIC_TEST

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

Healthy participantsPatients with COVID-19
SARS-CoV-2 Ig G levelsDIAGNOSTIC_TEST

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

Healthy participantsPatients with COVID-19
Testis pathology samplesOTHER

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

Patients with COVID-19

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical or imaging signs of COVID-19 infection
  • Nasopharyngeal swab positive for SARS-CoV2 mRNA

You may not qualify if:

  • Inability to collect semen for analysis
  • Congenital anomalies of the testes
  • Varicocele
  • A history of fertility disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sechenov University.

Moscow, 119991, Russia

RECRUITING

MeSH Terms

Conditions

COVID-19Infertility

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesGenital DiseasesUrogenital Diseases

Study Officials

  • Dmitry Enikeev, M.D.

    Sechenov University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dmitry Enikeev, M.D.

CONTACT

+79670897154dvenikeev@gmail.com

Mark Taratkin, M.D.

CONTACT

+79670897154marktaratkin@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Parallel groups, non-randomized: 1. \- patients with COVID-19; 2. \- healthy participants without COVID-19.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy Director for Research

Study Record Dates

First Submitted

January 17, 2021

First Posted

January 20, 2021

Study Start

January 18, 2021

Primary Completion

May 18, 2021

Study Completion

August 31, 2021

Last Updated

July 22, 2021

Record last verified: 2021-07

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)