Male InfertilityNCT04946565
The Impact of Sinopharm COVID-19 Vaccination on Male Fertility
An observational study of Male Infertility and Hypogonadism, Male, run by Cairo University at 1 site in Egypt.
Trial summary
The investigators shall study the effect of Sinopharm vaccination on semen parameters and serum testosterone Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Male Infertility, Hypogonadism, Male
- What is being tested?
- Semen analysis
- Type of treatment
- Vaccines
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Jul 2021to 30 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Men of reproductive age scheduled for COVID-19 Sinopharm Vaccine
Who may be able to join
- Receiving Sinopharm COVID-19 vaccines Male age 18-50 years old
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine, Cairo University
Cairo, 11562
About this study
Official title: 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
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.
- Conditions
- Male Infertility, Hypogonadism, Male
- Being tested
- Semen analysis
- Medical subject headings
- Infertility, Male, Eunuchism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Semen analysisDiagnostic test
Semen analysis according to WHO laboratory manual for the examination and processing of human semen, Fifth edition
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Semen analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sperm density count/ml
As measured from semen samples
Measured: up to 6 months
Total sperm count per ejaculate
As measured from semen samples
Measured: up to 6 months
Percentage of motile sperm
As measured from semen samples
Measured: up to 6 months
Percentage of abnormal sperm forms
As measured from semen samples
Measured: up to 6 months
Secondary outcomes (1)
Morning serum testosterone
Total serum testosterone measured using immunoassay
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2021
- Study start3 Jul 2021
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male InfertilityStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Tarek Anis, Cairo University
- Investigators
- Mohamed Tarek H Anis, M.D., Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04946565
- Sponsor's protocol ID
- TBA
- Status last verified
- Jul 2021
- First submitted
- 28 Jun 2021
- Last updated
- 7 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Sinopharm COVID-19 Vaccination on Male Fertility of the Egyptian Population
- ClinicalTrials.gov ID
- NCT04946565
- Acronym / sponsor ID
- TBA
- Conditions
- Male Infertility, Hypogonadism, Male
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 3 Jul 2021 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Aug 2022 (estimated)
- First posted
- 1 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sinopharm vaccine group | – | Diagnostic Test: Semen analysisParticipants scheduled to receive the Sinopharm vaccine will be evaluated on its effect on semen parameters for up to 6 months post vaccination. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Men of reproductive age scheduled for COVID-19 Sinopharm Vaccine
Key inclusion criteria (1 listed)
- Receiving Sinopharm COVID-19 vaccines Male age 18-50 years old
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Semen analysisSemen analysis according to WHO laboratory manual for the examination and processing of human semen, Fifth edition | Diagnostic test | Sinopharm vaccine group |
Primary outcome
Sperm density count/ml
Time frame: up to 6 months
As measured from semen samples
Total sperm count per ejaculate
Time frame: up to 6 months
As measured from semen samples
Percentage of motile sperm
Time frame: up to 6 months
As measured from semen samples
Percentage of abnormal sperm forms
Time frame: up to 6 months
As measured from semen samples
1 secondary outcome
Morning serum testosterone
Time frame: up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed Tarek H Anis, M.D. principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Male Infertility and Hypogonadism, Male, run by Cairo University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Tarek H Anis, M.D. (+201222163858, tarekanis@kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sperm density count/ml (time frame: up to 6 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2021.