Does COVİD-19 m-RNA Vaccine Affect Fertility and Over Reserve ?
1 other identifier
observational
64
1 country
1
Brief Summary
Women's ovarian reserve and fertility were compared before and after 2 doses of vaccination
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 30, 2022
CompletedStudy Start
First participant enrolled
February 1, 2022
CompletedFirst Posted
Study publicly available on registry
August 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 20, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2022
CompletedFebruary 22, 2023
August 1, 2022
9 months
January 30, 2022
February 21, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
AMH difference between vaccinated and unvaccinated groups
6 months
Study Arms (1)
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
Interventions
volunteers will be expected to receive 2 doses of vaccine
Eligibility Criteria
74 ovulatory women who were not vaccinated with Biontech.
You may qualify if:
- between 18-45 years old
- have ever had a covid vaccine
- not be infected with covid 19
You may not qualify if:
- pregnancy
- diagnosis of any kind of cancer
- oral contraceptive usage
- endometrioma
- PCOS
- menopause
- menstrual irregularity
- premature ovarian insufficiency
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gaziosmanpasa Training and Research Hospital
Istanbul, Gaziosmanpaşa, 32225, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Target Duration
- 8 Months
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- DOCTOR
Study Record Dates
First Submitted
January 30, 2022
First Posted
August 5, 2022
Study Start
February 1, 2022
Primary Completion
October 20, 2022
Study Completion
November 30, 2022
Last Updated
February 22, 2023
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share
A number will be given to each volunteer who agrees to participate in the study.All data obtained will be recorded in this number and all data will be stored on the personal computer of the researcher.No personal data will be shared with anyone other than the study.