Impact of Corona Vaccination on AMH- Anti Mullerian Hormone (Israel)

Wether Corona Vaccination Has Negative Impact on AMH- Anti Mullerian Hormone Which Express Ovarin Function

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.

Study Overview

• Status: Recruiting
• Conditions: Patient Participation
• Intervention / Treatment: Biological: Vcinated

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 90

Contacts and Locations

• Study Contact: Name: Eran Horowitz, M.D; Phone Number: +972-54-4991919; Email: eranh7@gmail.com

Study Locations

• Israel
  • Holon, Israel, 58100
    • Recruiting
    • Wolfson Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 44 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

Women who are going through IVF treatments.

Description

Inclusion Criteria:

• Age 18-44

Exclusion Criteria:

Age over 45

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Vaciinated; First group patients who vaccinated and measure the AMH before and up to 9 months after vaccination.	Biological: Vcinated; Patients who were vacinated.
Infected patients by covid-19 and not vacinated; Second group patients who were infected by Covid-19 ant therefor were not vaccinated
Not infected nor vacinated; Ptients who who were not infected nor vacinated by Covid-19.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amh levels	Before and after vacination	9 months

Collaborators and Investigators

• Sponsor: Wolfson Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2021
• Primary Completion (Anticipated): August 15, 2022
• Study Completion (Anticipated): October 15, 2022

Study Registration Dates

• First Submitted: August 29, 2021
• First Submitted That Met QC Criteria: August 29, 2021
• First Posted (Actual): September 5, 2021

Study Record Updates

• Last Update Posted (Actual): September 5, 2021
• Last Update Submitted That Met QC Criteria: August 29, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 0013-21-WOMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No