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Clinical trial

The Effect of COVID -19 mRNA Vaccine on Ovarian Reserve

ID
Name
8121-21-SMC
Description
As Israel is the first country to widely vaccinate its population using the mRNA vaccine against COVID-19, evaluating its influence on ovarian reserve is essential .
Trial arms
Trial start
2021-02-01
Estimated PCD
2023-06-01
Trial end
2023-06-01
Status
Completed
Treatment
SARS-CoV-2 virus vaccines
mRNA SARS-CoV-2 virus vaccines ( By Pfizer or Moderna)
Arms:
Study Group: Women who are planning to be vaccinated
AMH sampling
Blood sample for AMH on recruitment and after three months
Arms:
Study Group: Women who are planning to be vaccinated
anti Covid-19 antibody levels (Serology)
Blood sample for IgG against S1 protein after three months
Arms:
Study Group: Women who are planning to be vaccinated
Size
200
Primary endpoint
Delta in AMH levels
From first vaccination until the second AMH sampling - after three month
Eligibility criteria
Inclusion Criteria: * Age 11-42 * No previous exposure to Covid-19 vaccine (first or second dose) * No known past Covid-19 infection Exclusion Criteria: * Premature ovarian failure * Pregnancy * Fertility treatment * Past Covid-19 infection
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_CONTROL', 'timePerspective': 'PROSPECTIVE'}, 'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Blood samples evaluated for Anti Mullarian Hormone (AMH)'}, 'enrollmentInfo': {'count': 200, 'type': 'ACTUAL'}}
Updated at
2023-06-22

1 organization

1 product

2 indications

Organization
Sheba Medical Center
Product
SARS-CoV-2 virus vaccines
Indication
Infertility
Indication
Adverse Vaccine Reaction