Evaluation of the Effect of Coronavac Vaccine (Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2 Vaccine) on Healthcare Workers' Menstrual Patterns

Covid19 Clinical Trial

Official title:

the Effect of Coronavac Vaccine (Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2 Vaccine) on Healthcare Workers' Menstrual Patterns

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04854408
• Other study ID #: Coronavacendometrium
• Status: Completed
• Start date: March 18, 2021
• Est. completion date: May 9, 2021

Study information

• Verified date: April 2021
• Source: Kanuni Sultan Suleyman Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Coronavac, one of the vaccines developed within the scope of combating the COVID-19 pandemic that has surrounded the world for a year, started to be applied in the first healthcare workers in our country. In this important step taken to end the pandemic, information on vaccines is still limited. Most vaccines, including the Coronavac vaccine, are applied with approval for emergency use before phase 3 studies are fully completed. While investigating the effect of the vaccine on the virus, possible side effects should also be considered. In this context, it is not known whether the vaccine has an effect on the menstrual cycle, especially of women of reproductive age. Our primary aim in our study is to evaluate the effect of the vaccine on the menstrual cycle and if the vaccine has any effect on the menstrual cycle, what kind of changes this effect causes.

Description:

The survey contains 20 questions aimed at obtaining information about the menstrual cycles of health workers before and after vaccination. Demographic data of the participants are also taken.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: May 9, 2021
• Est. primary completion date: May 7, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• be positive for covid-19 (severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 )
• Having 1 or 2 doses of vaccine
• have menstruation
• Being a female health worker
• not using drugs that can affect menstruation

Exclusion Criteria:

• be negative for covid-19(severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 )
• have no menstruation
• Being a male health worker

Related Conditions & MeSH terms

• Coronavirus
• Coronavirus Infections
• Covid19
• Endometrium
• Menstrual Problem
• Menstruation Disturbances
• Severe Acute Respiratory Syndrome
• Vaccine Reaction

Intervention

Other:
• healthcare workers with the coronavac vaccine
Health workers who are vaccinated will fill in the 20-question survey electronically.

Locations

Country	Name	City	State
Turkey	Pinar Yalcin Bahat	Istanbul	I?stanbul

Sponsors (1)

Lead Sponsor	Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Possible effects of Coronavac vaccine (severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 vaccine) on menstrual cycle	The change in the menstrual cycle of vaccinated healthcare workers after the first or the second dose is questioned with 20 questions. The content of the question consists of yes and no questions explaining the general epidemiological data of the patients and the amount of menstruation. These questions question the amount and change of menstruation before and after the vaccine.	40 days