NCT05489367

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 64 (actual)
• Sponsor: Gaziosmanpasa Research and Education Hospital · Other Government
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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.

Conditions

• COVID-19 Virus Infection
• Ovarian Function Insufficiency
• Fertility Disorders
• Vaccine Adverse Reaction

Interventions

Type	Name	Description
BIOLOGICAL	sars cov 2 biontec vaccine	volunteers will be expected to receive 2 doses of vaccine

Timeline

• Start date: 2022-02-01
• Primary completion: 2022-10-20
• Completion: 2022-11-30
• First posted: 2022-08-05
• Last updated: 2023-02-22

Locations

1 site across 1 country: Turkey (Türkiye)

Regulatory

• FDA-regulated drug study