The Impact of Sinopharm COVID-19 Vaccination on Male Fertility

Male Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04946565
• Other study ID #: TBA
• Status: Recruiting
• Start date: July 3, 2021
• Est. completion date: August 30, 2022

Study information

• Verified date: July 2021
• Source: Cairo University
• Contact: Mohamed Tarek H Anis, M.D.
• Phone: +201222163858
• Email: tarekanis[@]kasralainy.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: August 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypogonadism
• Hypogonadism, Male
• Infertility
• Infertility, Male
• Male Infertility

Intervention

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

Locations

Country	Name	City	State
Egypt	Faculty of Medicine, Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sperm density count/ml	As measured from semen samples	up to 6 months
Primary	Total sperm count per ejaculate	As measured from semen samples	up to 6 months
Primary	Percentage of motile sperm	As measured from semen samples	up to 6 months
Primary	Percentage of abnormal sperm forms	As measured from semen samples	up to 6 months
Secondary	Morning serum testosterone	Total serum testosterone measured using immunoassay	up to 6 months