NCT04946565

Brief Summary

The investigators shall study the effect of Sinopharm vaccination on semen parameters and serum testosterone

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 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

June 28, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 1, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

July 3, 2021

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2022

Completed
Last Updated

July 7, 2021

Status Verified

July 1, 2021

Enrollment Period

12 months

First QC Date

June 28, 2021

Last Update Submit

July 3, 2021

Conditions

Outcome Measures

Primary Outcomes (4)

  • Sperm density count/ml

    As measured from semen samples

    up to 6 months

  • Total sperm count per ejaculate

    As measured from semen samples

    up to 6 months

  • Percentage of motile sperm

    As measured from semen samples

    up to 6 months

  • Percentage of abnormal sperm forms

    As measured from semen samples

    up to 6 months

Secondary Outcomes (1)

  • Morning serum testosterone

    up to 6 months

Study Arms (1)

Sinopharm vaccine group

Participants scheduled to receive the Sinopharm vaccine will be evaluated on its effect on semen parameters for up to 6 months post vaccination.

Diagnostic Test: Semen analysis

Interventions

Semen analysisDIAGNOSTIC_TEST

Semen analysis according to WHO laboratory manual for the examination and processing of human semen, Fifth edition

Sinopharm vaccine group

Eligibility Criteria

Age18 Years - 50 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Men of reproductive age scheduled for COVID-19 Sinopharm Vaccine

You may qualify if:

  • Receiving Sinopharm COVID-19 vaccines Male age 18-50 years old

You may not qualify if:

  • Adults unable to consent
  • Men who have been receiving Testosterone replacement therapy or anabolic steroids within the last year
  • Men with a history of male infertility
  • Men with a genetic or other medical condition known to be associated with decreased semen parameters Positive COVID-19 PCR test within the 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine, Cairo University

Cairo, 11562, Egypt

RECRUITING

MeSH Terms

Conditions

Infertility, MaleEunuchism

Interventions

Semen Analysis

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital DiseasesHypogonadismGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Mohamed Tarek H Anis, M.D.

    Cairo University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Tarek H Anis, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Andrology

Study Record Dates

First Submitted

June 28, 2021

First Posted

July 1, 2021

Study Start

July 3, 2021

Primary Completion

June 30, 2022

Study Completion

August 30, 2022

Last Updated

July 7, 2021

Record last verified: 2021-07

Locations