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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05489367
Enrollment
64
Registered
2022-08-05
Start date
2022-02-01
Completion date
2022-11-30
Last updated
2023-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

ovarian reserve, covid-19, vaccine

Brief 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.

Interventions

BIOLOGICALsars cov 2 biontec vaccine

volunteers will be expected to receive 2 doses of vaccine

Sponsors

Gaziosmanpasa Research and Education Hospital
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Ovarian reserve tests and fertility status of 74 women before and after vaccination6 months after receiving the 2nd dose of vaccinebefore and after vaccination serum Amh level ng/ml

Secondary

MeasureTime frameDescription
AMH difference between vaccinated and unvaccinated groups6 monthsAMH difference between vaccinated and unvaccinated groups

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026