Effect of Covid-19 Vaccination on Male

March 29, 2022 updated by: mohamed el mahdy abdelmotaleb, Assiut University

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

220

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Hatem kamal, MD
  • Phone Number: 012345235645

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

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).

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2022

Primary Completion (Anticipated)

November 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

March 27, 2022

First Submitted That Met QC Criteria

March 27, 2022

First Posted (Actual)

March 29, 2022

Study Record Updates

Last Update Posted (Actual)

April 6, 2022

Last Update Submitted That Met QC Criteria

March 29, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Effect of Covid-19 Vaccination

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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