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

Sponsor
Kanuni Sultan Suleyman Training and Research Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT04854408
Collaborator
(none)
300
Enrollment
1
Location
1.7
Actual Duration (Months)
175.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Other: healthcare workers with the coronavac vaccine

Detailed 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.

Study Design

Study Type:
Observational
Actual Enrollment :
300 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
the Effect of Coronavac Vaccine (Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2 Vaccine) on Healthcare Workers' Menstrual Patterns
Actual Study Start Date :
Mar 18, 2021
Actual Primary Completion Date :
May 7, 2021
Actual Study Completion Date :
May 9, 2021

Outcome Measures

Primary Outcome Measures

  1. Possible effects of Coronavac vaccine (severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2 vaccine) on menstrual cycle [40 days]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Pinar Yalcin Bahat Istanbul İ̇stanbul Turkey 34000

Sponsors and Collaborators

  • Kanuni Sultan Suleyman Training and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Pınar Yalcin bahat, Principal Investigator, Kanuni Sultan Suleyman Training and Research Hospital
ClinicalTrials.gov Identifier:
NCT04854408
Other Study ID Numbers:
  • Coronavacendometrium
First Posted:
Apr 22, 2021
Last Update Posted:
May 11, 2021
Last Verified:
Apr 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Coronavirus Infections
Severe Acute Respiratory Syndrome
Menstruation Disturbances

Study Results

No Results Posted as of May 11, 2021