ClinicalTrials.gg
Status unknownNCT04946565Updated Jul 7, 2021

The Impact of Sinopharm COVID-19 Vaccination on Male Fertility

An observational study in Male Infertility and Hypogonadism, Male, sponsored by Cairo University. Status unknown at 1 site in Egypt. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-07.

Sponsored by Cairo University · Observational

The sponsor has not verified this record recently (last verified Jul 2021), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
100
Ages
18 Years to 50 Years
Sex
Male
01

Study summary

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

Read the 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.

02

Conditions studied

  • Male Infertility
  • Hypogonadism, Male
03

In context

Infertility, Male

282 studies on the registry are indexed under Infertility, Male; 65 are open to participants now.

This study's planned enrollment of 100 is below the median of 182 across 87 observational studies indexed under Infertility, Male.

Browse Infertility, Male studies →

Lead sponsor

Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.

Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
Male
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Men of reproductive age scheduled for COVID-19 Sinopharm Vaccine

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic testSemen analysis

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

06

What researchers measure

Primary outcomes

  1. Sperm density count/ml

    As measured from semen samples

    Time frame: up to 6 months

  2. Total sperm count per ejaculate

    As measured from semen samples

    Time frame: up to 6 months

  3. Percentage of motile sperm

    As measured from semen samples

    Time frame: up to 6 months

  4. Percentage of abnormal sperm forms

    As measured from semen samples

    Time frame: up to 6 months

Secondary outcomes

  1. Morning serum testosterone

    Total serum testosterone measured using immunoassay

    Time frame: up to 6 months

07

Study locations

1 of 1 sites recruiting
  • Faculty of Medicine, Cairo University
    Cairo, 11562, Egypt
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 7, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04946565
Lead sponsor
Cairo University
Responsible party
Mohamed Tarek Anis (Professor of Andrology, Cairo University) — Principal investigator
First posted
Jul 1, 2021
Start date
Jul 3, 2021
Primary completion
Jun 30, 2022 (estimated)
Completion
Aug 30, 2022 (estimated)
Last update
Jul 7, 2021

Study contacts

Mohamed Tarek H Anis, M.D.
Contact
tarekanis@kasralainy.edu.eg
+201222163858
Islam Fathy, M.D.
Contact
islamandrology@yahoo.com
+201004244360
Mohamed Tarek H Anis, M.D.
principal investigator · Cairo University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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