The Impact of Sinopharm COVID-19 Vaccination on Male Fertility

• Conditions: Male Infertility; Hypogonadism, Male
• Interventions: Diagnostic Test: Semen analysis

• Registration Number: NCT04946565
• Lead Sponsor: Cairo University

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-06-28
• Study First Submitted QC: 2021-06-28
• Status Verified: 2021-07
• Study First Posted: 2021-07-01
• Study Start: 2021-07-03
• Last Update Submitted: 2021-07-03
• Last Update Posted: 2021-07-07
• Primary Completion: 2022-06-30
• Study Completion: 2022-08-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sinopharm vaccine group	Semen analysis	Participants scheduled to receive the Sinopharm vaccine will be evaluated on its effect on semen parameters for up to 6 months post vaccination.

Primary Outcome Measures

Name	Time	Method
Total sperm count per ejaculate	up to 6 months	As measured from semen samples
Percentage of motile sperm	up to 6 months	As measured from semen samples
Sperm density count/ml	up to 6 months	As measured from semen samples
Percentage of abnormal sperm forms	up to 6 months	As measured from semen samples

Secondary Outcome Measures

Name	Time	Method
Morning serum testosterone	up to 6 months	Total serum testosterone measured using immunoassay

Trial Locations

Locations (1)

Faculty of Medicine, Cairo University; 🇪🇬 Cairo, Egypt