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临床试验/NCT05489367
NCT05489367已完成不适用

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

Gaziosmanpasa Research and Education Hospital1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2022年2月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
64
试验地点
1
主要终点
Ovarian reserve tests and fertility status of 74 women before and after vaccination

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

Ovarian reserve tests and fertility status of 74 women before and after vaccination

时间窗: 6 months after receiving the 2nd dose of vaccine

before and after vaccination serum Amh level ng/ml

次要结局

  • AMH difference between vaccinated and unvaccinated groups(6 months)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Elif Yıldız

DOCTOR

Gaziosmanpasa Research and Education Hospital

研究点 (1)

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