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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05034679
Other study ID # 0013-21-WOMC
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 15, 2021
Est. completion date October 15, 2022

Study information

Verified date August 2021
Source Wolfson Medical Center
Contact Eran Horowitz, M.D
Phone +972-54-4991919
Email eranh7@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Since December 2020 Nationwide anti-COVID-19 vaccination began in Israel using the Pfizer - BioNtech vaccine (BNT162b2 mRNA). The vaccination campaign has been associated with concerns regarding potential detrimental effects on future fertility. The aim of the study is to determine the impact of COVID-19 vaccination on n AMH- Anti Mullerian Hormone which express ovarin function. disease and/or immunization on human follicular function, by comparing follicular steroidogenesis, response to the LH/hCG trigger, and oocyte quality biomarker (HSPG2), in the aspirated follicular fluid of patients undergoing ovum pick-up.


Description:

Our assumption is that there is no effect of the vaccination on the AMH level. We plan to recruit 90 patients who are divided to three groups First group patients who vaccinated and measure the AMH before and up to 9 months after vaccination. Second group patients who were infected by Covid-19 ant therefor were not vaccinated to compare the AMH level before and after the infectious. The third group patients who were not infected and not vaccinated.


Recruitment information / eligibility

Status Recruiting
Enrollment 90
Est. completion date October 15, 2022
Est. primary completion date August 15, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 44 Years
Eligibility Inclusion Criteria: - Age 18-44 Exclusion Criteria: Age over 45

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Vcinated
Patients who were vacinated.

Locations

Country Name City State
Israel Wolfson medical center Holon

Sponsors (1)

Lead Sponsor Collaborator
Wolfson Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Amh levels Before and after vacination 9 months
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