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OpenTrials
Completed

NCT Number: NCT05489367

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

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

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Key information

Conditions

COVID-19 Virus Infection COVID-19 Coronaviridae Infections Coronavirus Infections Fertility Disorders Infections Lung Diseases Nidovirales Infections Ovarian Function Insufficiency Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Vaccine Adverse Reaction Virus Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

Gaziosmanpasa Training and Research Hospital

Istanbul, Gaziosmanpaşa, 32225, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sars cov 2 biontec vaccine

Biological

volunteers will be expected to receive 2 doses of vaccine

Primary outcomes

  1. 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

Secondary outcomes

  1. AMH difference between vaccinated and unvaccinated groups

    Time frame: 6 months

    AMH difference between vaccinated and unvaccinated groups

Sponsors and collaborators

Lead sponsor

Gaziosmanpasa Research and Education Hospital

Other Gov

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 5, 2022
Registry last updated
Feb 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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