Does COVİD-19 m-RNA Vaccine Affect Fertility and Over Reserve ?
Study Details
Study Description
Brief Summary
Women's ovarian reserve and fertility were compared before and after 2 doses of vaccination
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Pre-vaccine ovarian reserve and fertility status 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
volunteers will be expected to receive 2 doses of vaccine
|
Outcome Measures
Primary Outcome Measures
- 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
- AMH difference between vaccinated and unvaccinated groups [6 months]
AMH difference between vaccinated and unvaccinated groups
Eligibility Criteria
Criteria
Inclusion Criteria:
-
between 18-45 years old
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have ever had a covid vaccine
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not be infected with covid 19
Exclusion Criteria:
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pregnancy
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diagnosis of any kind of cancer
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oral contraceptive usage
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endometrioma
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PCOS
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menopause
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menstrual irregularity
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premature ovarian insufficiency
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Gaziosmanpasa Training and Research Hospital | Istanbul | Gaziosmanpaşa | Turkey | 32225 |
Sponsors and Collaborators
- Gaziosmanpasa Research and Education Hospital
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GaziosmanpasaTREHm