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COVID-19 Vaccine and Ovarian Reserve

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04748172
Recruitment Status : Active, not recruiting
First Posted : February 10, 2021
Last Update Posted : January 13, 2022
Sponsor:
Information provided by (Responsible Party):
Dr. Aya Mohr-Sasson, Sheba Medical Center

Study Description
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Brief Summary:
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 .

Condition or disease Intervention/treatment
Fertility Issues Vaccine Adverse Reaction Biological: SARS-CoV-2 virus vaccines Diagnostic Test: AMH sampling Diagnostic Test: anti Covid-19 antibody levels (Serology)

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Study Design
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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: The Effect of COVID -19 mRNA Vaccine on Ovarian Reserve
Actual Study Start Date : February 1, 2021
Estimated Primary Completion Date : February 2022
Estimated Study Completion Date : February 2022

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Groups and Cohorts
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Group/Cohort Intervention/treatment
Study Group: Women who are planning to be vaccinated
Women that are planning to be vaccinated, before receiving the first shot of the vaccine
 Biological: SARS-CoV-2 virus vaccines
mRNA SARS-CoV-2 virus vaccines ( By Pfizer or Moderna)

Diagnostic Test: AMH sampling
Blood sample for AMH on recruitment and after three months

Diagnostic Test: anti Covid-19 antibody levels (Serology)
Blood sample for IgG against S1 protein after three months


Outcome Measures
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Primary Outcome Measures :
  1. Delta in AMH levels [ Time Frame: From first vaccination until the second AMH sampling - after three month ]
    AMA levels on recruitment minos AMH levels after three months


Biospecimen Retention:   Samples Without DNA
Blood samples evaluated for Anti Mullarian Hormone (AMH)

Eligibility Criteria
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Ages Eligible for Study:   11 Years to 42 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Women in reproductive age
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Females (age 11 to 42) that are planning to be vaccinated in Israel
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04748172


Locations
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Israel
Sheba Medical Center
Ramat-Gan, Israel, 56506
Sponsors and Collaborators
Sheba Medical Center
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Dr. Aya Mohr-Sasson, Principal Investigator, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT04748172    
Other Study ID Numbers: 8121-21-SMC
First Posted: February 10, 2021    Key Record Dates
Last Update Posted: January 13, 2022
Last Verified: December 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: On request

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Aya Mohr-Sasson, Sheba Medical Center:
Ovarian reserve
Corona-19 virus
SARS-CoV-2
Additional relevant MeSH terms:
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Infertility
Antibodies
Immunologic Factors
Physiological Effects of Drugs