Effect of Covid-19 Vaccination on Male

COVID-19 Pandemic Clinical Trial

Official title:

The Impact of Covid-19 Vaccination on the Reproductive and Sexual Function in Sample of Male Egyptian Population

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05299307
• Other study ID #: Effect of Covid-19 Vaccination
• Status: Not yet recruiting
• Start date: April 2022
• Est. completion date: December 2022

Study information

• Verified date: March 2022
• Source: Assiut University
• Contact: mohamed Toiema, MD
• Phone: 01098665809
• Email: mohamed_elmahdy[@]med.aun.edu.eg
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

we will assess the effect ofcovid19 vaccination on the reproductive and sexual function of the Male Egyptian

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 220
• Est. completion date: December 2022
• Est. primary completion date: November 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 20 Years to 55 Years

Eligibility

Inclusion Criteria:

• Male patients receive covid 19 vaccinations. Age from 20 to 55 years

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pandemic

Intervention

Diagnostic Test:
• semen analysis and hormonal proflie
measure total prolactin and total testosterone and semen

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (2)

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. Review. — View Citation

Baran 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Baseline