Does COVİD-19 m-RNA Vaccine Affect Fertility and Over Reserve ?

February 21, 2023 updated by: Elif Yıldız, Gaziosmanpasa Research and Education Hospital
Women's ovarian reserve and fertility were compared before and after 2 doses of vaccination

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

our study ıs desıgned as an observatıonal clınıcal study. the purpose ıs to compare the over reserve tests of the patıents before and after vaccıne, to determıne ıf the over reserve and fertılıty of women are affected by the vaccıne.women who applied to the vaccination outpatient clinic for the first dose of vaccine were included in the study.those who have never been vaccinated and have not had covid 19 infection were included in the study.antı ullerıan hormone level ıs the laboratory parameters that best showıng the ovary reserve today. ovarian reserve tests including amh were checked and their fertility was questioned and their information was recorded.

the same tests were repeated after the volunteers received 2 doses of vaccine. ın the power analysis, it was calculated that 104 volunteers should be included in the study.the study will be terminated when 104 volunteers are reached.

Study Type

Observational

Enrollment (Actual)

64

Contacts and Locations

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

Study Locations

  • Turkey
    • Gaziosmanpaşa
      • Istanbul, Gaziosmanpaşa, Turkey, 32225
        • Gaziosmanpaşa Training and Research Hospital

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

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

74 ovulatory women who were not vaccinated with Biontech.

Description

Inclusion Criteria:

  • between 18-45 years old
  • have ever had a covid vaccine
  • not be infected with covid 19

Exclusion Criteria:

  • pregnancy
  • diagnosis of any kind of cancer
  • oral contraceptive usage
  • endometrioma
  • PCOS
  • menopause
  • menstrual irregularity
  • premature ovarian insufficiency

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

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Pre-vaccine ovarian reserve and fertility status
Before vaccination, ovarian reserve tests and fertility status of 64 women will be examined and results will be recorded.After 2 doses of vaccination, ovarian reserve and fertility status of same 64 women will be examined and results will be recorded
Biological: sars cov 2 biontec vaccine
volunteers will be expected to receive 2 doses of vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ovarian reserve tests and fertility status of 74 women before and after vaccination
Time Frame: 6 months after receiving the 2nd dose of vaccine
before and after vaccination serum Amh level ng/ml
6 months after receiving the 2nd dose of vaccine

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AMH difference between vaccinated and unvaccinated groups
Time Frame: 6 months
AMH difference between vaccinated and unvaccinated groups
6 months

Collaborators and Investigators

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

Sponsor

Gaziosmanpasa Research and Education Hospital

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 (Actual)

February 1, 2022

Primary Completion (Actual)

October 20, 2022

Study Completion (Actual)

November 30, 2022

Study Registration Dates

First Submitted

January 30, 2022

First Submitted That Met QC Criteria

August 3, 2022

First Posted (Actual)

August 5, 2022

Study Record Updates

Last Update Posted (Estimate)

February 22, 2023

Last Update Submitted That Met QC Criteria

February 21, 2023

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GaziosmanpasaTREHm

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

A number will be given to each volunteer who agrees to participate in the study.All data obtained will be recorded in this number and all data will be stored on the personal computer of the researcher.No personal data will be shared with anyone other than the study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

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.

Clinical Trials on Vaccine Adverse Reaction

Clinical Trials on sars cov 2 biontec vaccine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Mauritius

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe