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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04748172
Recruitment Status : Recruiting
First Posted : February 10, 2021
Last Update Posted : March 26, 2021
Sponsor:
Information provided by (Responsible Party):
Dr. Aya Mohr-Sasson, Sheba Medical Center

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

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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

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

Control Group: Women who are not planning to be vaccinated
Women visiting other ambulatory clinics that are not planning to be vaccinated
Diagnostic Test: AMH sampling
Blood sample for AMH on recruitment and after three months




Primary Outcome Measures :
  1. Delta in AMH levels [ Time Frame: From first vaccination untill 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)


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Ages Eligible for Study:   18 Years to 42 Years   (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
Reproductive age women (age 18 to 42) that are planning to be vaccinated in Israel
Criteria

Inclusion Criteria:

  • Age 18-42
  • No previous exposure to covid-19 vaccine (first or second dose)
  • No known past Covid-19 infection

Exclusion Criteria:

  • Premature ovarian failure
  • Endometriosis
  • Polycystic ovary syndrome
  • Pregnancy
  • Fertility treatment

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 Recruiting
Ramat-Gan, Israel, 56506
Contact: Dr. A Mohr-Sasson, M.D    97235302777 ext 97235302777    mohraya@gmail.com   
Contact: Aya Mohr- Sasson, M.D    0523692906    mohraya@gmail.com   
Sponsors and Collaborators
Sheba Medical Center
Publications of Results:

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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: March 26, 2021
Last Verified: February 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