The Impact of Sinopharm COVID-19 Vaccination on Male Fertility

July 3, 2021 updated by: Mohamed Tarek Anis, Cairo University

The Impact of Sinopharm COVID-19 Vaccination on Male Fertility of the Egyptian Population

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The investigators shall compare semen parameter (sperm density, sperm motility, and percentage of abnormal sperm form) as well as morning serum testosterone before vaccination, and 3 months after the second dose of the vaccine.

Study Type

Observational

Enrollment (Anticipated)

100

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 Backup

Study Locations

  • Egypt
      • Cairo, Egypt, 11562
        • Recruiting
        • Faculty of Medicine, Cairo University

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

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Men of reproductive age scheduled for COVID-19 Sinopharm Vaccine

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

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

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Semen analysis according to WHO laboratory manual for the examination and processing of human semen, Fifth edition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sperm density count/ml
Time Frame: up to 6 months
As measured from semen samples
up to 6 months
Total sperm count per ejaculate
Time Frame: up to 6 months
As measured from semen samples
up to 6 months
Percentage of motile sperm
Time Frame: up to 6 months
As measured from semen samples
up to 6 months
Percentage of abnormal sperm forms
Time Frame: up to 6 months
As measured from semen samples
up to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Morning serum testosterone
Time Frame: up to 6 months
Total serum testosterone measured using immunoassay
up to 6 months

Collaborators and Investigators

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

Sponsor

Cairo University

Investigators

  • Principal Investigator: Mohamed Tarek H Anis, M.D., Cairo university

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 (Actual)

July 3, 2021

Primary Completion (Anticipated)

June 30, 2022

Study Completion (Anticipated)

August 30, 2022

Study Registration Dates

First Submitted

June 28, 2021

First Submitted That Met QC Criteria

June 28, 2021

First Posted (Actual)

July 1, 2021

Study Record Updates

Last Update Posted (Actual)

July 7, 2021

Last Update Submitted That Met QC Criteria

July 3, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TBA

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.

Clinical Trials on Male Infertility

Clinical Trials on Semen analysis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Russia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe