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

Study Overview
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Brief Summary
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Women's ovarian reserve and fertility were compared before and after 2 doses of vaccination

Detailed Description
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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.

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

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

Intervention / Treatment
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* Biological: sars cov 2 biontec vaccine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pre-vaccine ovarian reserve and fertility status<br>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<br>* volunteers will be expected to receive 2 doses of vaccine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ovarian reserve tests and fertility status of 74 women before and after vaccination | 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 | AMH difference between vaccinated and unvaccinated groups | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ovarian reserve, covid-19, vaccine