NCT04595240

Brief Summary

The viral pandemic of the coronavirus disease 2019 (COVID-19), generated by a novel mutated severe acute respiratory syndrome coronavirus (SARS-CoV-2), has become a serious worldwide public health emergency, evolving exponentially. While the main organ targeted in this disease is the lungs, other vital organs, such as the heart and kidney, may be implicated. The main host receptor of the SARS-CoV-2 is angiotensin converting enzyme 2 (ACE2), a major component of the renin-angiotensin-aldosterone system (RAAS). The ACE2 is also involved in testicular male regulation of steroidogenesis and spermatogenesis. As the SARS-CoV-2 may have the potential to infect the testis via ACE2 and adversely affect male reproductive system.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

May 1, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

October 14, 2020

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 20, 2020

Completed
Last Updated

October 20, 2020

Status Verified

October 1, 2020

Enrollment Period

6 months

First QC Date

October 14, 2020

Last Update Submit

October 19, 2020

Conditions

Covid19

Outcome Measures

Primary Outcomes (8)

  • changes of semen volume in (ML)by covid-19 from normal values.

    semen analysis taken by 72day of infection to see the effect on the new cycle of spermatogenesis

    72days after infection

  • changes of sperm concentration in (million/ml) by covid-19 from normal values.

    semen analysis taken by 72day of infection to see the effect on the new cycle of spermatogenesis

    72days after infection

  • changes of sperm morphology in (percentage of normal forms) by covid-19 from normal values.

    semen analysis taken by 72day of infection to see the effect on the new cycle of spermatogenesis

    72days after infection

  • changes of sperm motility in percentage of (A+B) by covid-19 from normal values.

    semen analysis taken by 72day of infection to see the effect on the new cycle of spermatogenesis

    72days after infection

  • changes of semen volume in (ML) by covid-19 from from the first sample

    semen analysis taken by 72day of the first negative swab of covid-19 to see the effect on the new cycle of spermatogenesisand to compare with the first sample which done during infection.

    after 72 days of the first sample

  • changes of sperm concentration in (million /ML) by covid-19 from from the first sample

    semen analysis taken by 72day of the first negative swab of covid-19 to see the effect on the new cycle of spermatogenesisand to compare with the first sample which done during infection.

    after 72 days of the first sample

  • changes of sperm morphology in percentage of normal form by covid-19 from from the first sample

    semen analysis taken by 72day of the first negative swab of covid-19 to see the effect on the new cycle of spermatogenesisand to compare with the first sample which done during infection.

    after 72 days of the first sample

  • changes of sperm motility in percentage of (A+B) by covid-19 from from the first sample

    semen analysis taken by 72day of the first negative swab of covid-19 to see the effect on the new cycle of spermatogenesisand to compare with the first sample which done during infection.

    after 72 days of the first sample

Interventions

semen analysisDIAGNOSTIC_TEST

semen analysis

Eligibility Criteria

Age20 Years - 45 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

men with th mentioned criteria

You may qualify if:

  • adult male patient age younger than 45 years old
  • no history of fertility disorders
  • good body built and secondary sexual charcter .

You may not qualify if:

  • congenital anomalies of the testis
  • chronically ill patients
  • proplems of male fertility
  • males with varicocele
  • sexual performance disorders .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mostafa Kamel

Asyut, 71511, Egypt

Location

Related Publications (1)

  • Mohammed N, Kamel M, Gadelkareem RA, Zarzour MA, Kurkar A, Abdel-Moniem AM, Behnsawy H. Semen quality changes during infection and recovery phases of mild-to-moderate COVID-19 in reproductive-aged patients: a prospective case series. Basic Clin Androl. 2023 Jan 19;33(1):2. doi: 10.1186/s12610-022-00175-7.

    PMID: 36653786DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Semen Analysis

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • ahmed a abdel moniem, md

    Assiut University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
investigator

Study Record Dates

First Submitted

October 14, 2020

First Posted

October 20, 2020

Study Start

May 1, 2020

Primary Completion

October 15, 2020

Study Completion

October 15, 2020

Last Updated

October 20, 2020

Record last verified: 2020-10

Locations

EG(1)