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

Completed

• Conditions: COVID-19 Virus Infection; Ovarian Function Insufficiency; Fertility Disorders; Vaccine Adverse Reaction
• Interventions: Biological: sars cov 2 biontec vaccine

• Registration Number: NCT05489367
• Lead Sponsor: Gaziosmanpasa Research and Education Hospital

Brief Summary

Women's ovarian reserve and fertility were compared before and after 2 doses of vaccination

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 Timeline

• Study First Submitted: 2022-01-30
• Study Start: 2022-02-01
• Status Verified: 2022-08
• Study First Submitted QC: 2022-08-03
• Study First Posted: 2022-08-05
• Primary Completion: 2022-10-20
• Study Completion: 2022-11-30
• Last Update Submitted: 2023-02-21
• Last Update Posted: 2023-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 64

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pre-vaccine ovarian reserve and fertility status	sars cov 2 biontec vaccine	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

Primary Outcome Measures

Name	Time	Method
Ovarian reserve tests and fertility status of 74 women before and after vaccination	6 months after receiving the 2nd dose of vaccine	before and after vaccination serum Amh level ng/ml

Secondary Outcome Measures

Name	Time	Method
AMH difference between vaccinated and unvaccinated groups	6 months	AMH difference between vaccinated and unvaccinated groups

Trial Locations

Locations (1)

Gaziosmanpasa Training and Research Hospital; 🇹🇷 Istanbul, Gaziosmanpaşa, Turkey