COVID-19 PandemicNCT05299307
Effect of Covid-19 Vaccination on Male
An observational study of COVID-19 Pandemic, run by Assiut University.
Trial summary
we will assess the effect ofcovid19 vaccination on the reproductive and sexual function of the Male Egyptian Read more about this study
- Who is it for?
- Ages 20 to 55 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Pandemic
- What is being tested?
- semen analysis and hormonal proflie
- How many people
- 220 participants
- Where
- No sites listed yet
- Study dates
- Apr 2022to Dec 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 20 to 55 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: We shall also compare the sexual function of men as well as the reproductive function of men before and after covid 19 vaccination receiving two doses .We shall also compare the sexual function of men as well as the reproductive function of men after covid 19 vaccination receiving two doses and after receiving 3 doses(booster dose).
Who may be able to join
- Male patients receive covid 19 vaccinations. Age from 20 to 55 years
Who cannot join
- Patients complaining of ED or any sexual dysfunction before Vaccination.
- Patients with history of male infertility before Vaccination.
- Patients who have pyschological disorders or any other systemicdiseases
Trial locations and contacts
No sites are listed yet.
Hatem kamal, MD contact
About this study
Official title: The Impact of Covid-19 Vaccination on the Reproductive and Sexual Function in Sample of Male Egyptian Population
we will assess the effect ofcovid19 vaccination on the reproductive and sexual function of the Male Egyptian
Read the detailed description
Coronaviruses are a group of RNA viruses that primarily affect the respiratory system and cause the common cold, fever, and coughs in mammals and birds. However, in some cases, coronaviruses are associated with more serious and lethal conditions, such as pneumonia, bronchitis, and severe acute respiratory syndrome .
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) originating from Wuhan, China, led to a global health crisis. SARS-CoV-2 had infected more than 450 million people, resulting in more than 6.6 million deaths. The World Health Organization (WHO) declared coronavirus disease 2019 (COVID-19), the infectious disease caused by SARS-CoV-2, a pandemic, and many states enacted strict rules, such as border closures, transportation restrictions, and quarantine.
Quality and satisfying sexual life have a positive effect on the social and daily relationships as well as on the intimate life of many individuals. The WHO summarizes the definition of sexual health as the physical, emotional, mental, and social well-being of an individual. On the other hand, sexual dysfunction can be described as any condition preventing the individual from being satisfied by the sexual activity at any stage of the sexual relationship.
The renin-angiotensin system (RAS), also ACE 2 and TMPRSS2 play an important role in the cellular entry for SARS-CoV-2. Because the male genital system presents high ACE 2 expression, the importance of this pathway increases in COVID-19 cases. As the COVID-19 pandemic has affected the male genital system in direct or indirect ways and showed a negative impact on male reproduction Ozer Baran and Aykut Aykac et al reported that the fear of infection and transmission of the disease to the partner that occurs during the Covid-19 pandemic manifests itself in the form of a decrease in the frequency and quality of sexual intercourse.
A COVID 19 vaccine is a biotechnology product intended to provide acquired immunity against corona virus disease 2019 (COVID 19) As of 1st June 2020, there were 124 candidate vaccines that were being developed for the prophylaxis of COVID-19. Of these, 10 vaccine candidates had entered phase1, combined phase 1/2 or phase 2 human clinical trials in adults
- Conditions
- COVID-19 Pandemic
- Being tested
- semen analysis and hormonal proflie
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
semen analysis and hormonal proflieDiagnostic test
measure total prolactin and total testosterone and semen
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Covid19 Vaccination on the reproductive and sexual function in a sample of Egyptian population
Analysis the effect of the vaccination on the semen parameters and sexual function
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2022
- Study startApr 2022 (estimated)
- Primary completionNov 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID-19 PandemicStudies of the same condition, open and under way.
- More trials run by Assiut 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-control
- Time perspective
- Prospective
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohamed el mahdy abdelmotaleb, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05299307
- Sponsor's protocol ID
- Effect of Covid-19 Vaccination
- Status last verified
- Mar 2022
- First submitted
- 27 Mar 2022
- Last updated
- 6 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Adhikari SP, Meng S, Wu YJ, Mao YP, Ye RX, Wang QZ, Sun C, Sylvia S, Rozelle S, Raat H, Zhou H. Epidemiology, causes, clinical manifestation and diagnosis, prevention and control of coronavirus disease (COVID-19) during the early outbreak period: a scoping review. Infect Dis Poverty. 2020 Mar 17;9(1):29. doi: 10.1186/s40249-020-00646-x.
PubMed 32183901Baran O, Aykac A. The effect of fear of covid-19 transmission on male sexual behaviour: A cross-sectional survey study. Int J Clin Pract. 2021 Apr;75(4):e13889. doi: 10.1111/ijcp.13889. Epub 2020 Dec 12.
PubMed 33280187
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Covid-19 Vaccination on the Reproductive and Sexual Function in Sample of Male Egyptian Population
- ClinicalTrials.gov ID
- NCT05299307
- Acronym / sponsor ID
- Effect of Covid-19 Vaccination
- Conditions
- COVID-19 Pandemic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Apr 2022 (estimated)
- Primary completion
- Nov 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 29 Mar 2022 (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.
we will assess the effect ofcovid19 vaccination on the reproductive and sexual function of the Male Egyptian
Detailed description
Coronaviruses are a group of RNA viruses that primarily affect the respiratory system and cause the common cold, fever, and coughs in mammals and birds. However, in some cases, coronaviruses are associated with more serious and lethal conditions, such as pneumonia, bronchitis, and severe acute respiratory syndrome .
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) originating from Wuhan, China, led to a global health crisis. SARS-CoV-2 had infected more than 450 million people, resulting in more than 6.6 million deaths. The World Health Organization (WHO) declared coronavirus disease 2019 (COVID-19), the infectious disease caused by SARS-CoV-2, a pandemic, and many states enacted strict rules, such as border closures, transportation restrictions, and quarantine.
Quality and satisfying sexual life have a positive effect on the social and daily relationships as well as on the intimate life of many individuals. The WHO summarizes the definition of sexual health as the physical, emotional, mental, and social well-being of an individual. On the other hand, sexual dysfunction can be described as any condition preventing the individual from being satisfied by the sexual activity at any stage of the sexual relationship.
The renin-angiotensin system (RAS), also ACE 2 and TMPRSS2 play an important role in the cellular entry for SARS-CoV-2. Because the male genital system presents high ACE 2 expression, the importance of this pathway increases in COVID-19 cases. As the COVID-19 pandemic has affected the male genital system in direct or indirect ways and showed a negative impact on male reproduction Ozer Baran and Aykut Aykac et al reported that the fear of infection and transmission of the disease to the partner that occurs during the Covid-19 pandemic manifests itself in the form of a decrease in the frequency and quality of sexual intercourse.
A COVID 19 vaccine is a biotechnology product intended to provide acquired immunity against corona virus disease 2019 (COVID 19) As of 1st June 2020, there were 124 candidate vaccines that were being developed for the prophylaxis of COVID-19. Of these, 10 vaccine candidates had entered phase1, combined phase 1/2 or phase 2 human clinical trials in adults
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 55 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- We shall also compare the sexual function of men as well as the reproductive function of men before and after covid 19 vaccination receiving two doses .We shall also compare the sexual function of men as well as the reproductive function of men after covid 19 vaccination receiving two doses and after receiving 3 doses(booster dose).
Key inclusion criteria (1 listed)
- Male patients receive covid 19 vaccinations. Age from 20 to 55 years
Key exclusion criteria (3 listed)
- Patients complaining of ED or any sexual dysfunction before Vaccination.
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 analysis and hormonal profliemeasure total prolactin and total testosterone and semen | Diagnostic test | – |
Primary outcome
Effect of Covid19 Vaccination on the reproductive and sexual function in a sample of Egyptian population
Time frame: Baseline
Analysis the effect of the vaccination on the semen parameters and sexual function
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Background: PubMed 32183901Adhikari SP, Meng S, Wu YJ, Mao YP, Ye RX, Wang QZ, Sun C, Sylvia S, Rozelle S, Raat H, Zhou H. Epidemiology, causes, clinical manifestation and diagnosis, prevention and control of coronavirus disease (COVID-19) during the early outbreak period: a scoping review. Infect Dis Poverty. 2020 Mar 17;9(1):29. doi: 10.1186/s40249-020-00646-x.
- Background: PubMed 33280187Baran O, Aykac A. The effect of fear of covid-19 transmission on male sexual behaviour: A cross-sectional survey study. Int J Clin Pract. 2021 Apr;75(4):e13889. doi: 10.1111/ijcp.13889. Epub 2020 Dec 12.
- Individual participant dataSharing planned: No
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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.
Hatem kamal, MD contact
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Pandemic, run by Assiut University.
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 3 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 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Toiema, MD (01098665809, mohamed_elmahdy@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of Covid19 Vaccination on the reproductive and sexual function in a sample of Egyptian population (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05299307, which also lists 2 linked publications.
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 6 Apr 2022.