## Protocol Section
### Identification Module
**NCT ID:** NCT05034679

**Acronym:** Israel

**Brief Title:** Impact of Corona Vaccination on AMH- Anti Mullerian Hormone

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

#### Organization Study ID Info
**ID:** 0013-21-WOMC
#### Organization
**Class:** OTHER_GOV
**Full Name:** Wolfson Medical Center
### Status Module
#### Completion Date
**Date:** 2022-10-15

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2021-09-05

**Type:** ACTUAL

**Last Update Submit Date:** 2021-08-29

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2022-08-15

**Type:** ESTIMATED

#### Start Date
**Date:** 2021-07-15

**Type:** ACTUAL

**Status Verified Date:** 2021-08

#### Study First Post Date
**Date:** 2021-09-05
**Type:** ACTUAL
**Study First Submit Date:** 2021-08-29
**Study First Submit QC Date:** 2021-08-29
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER_GOV

**Name:** Wolfson Medical Center

#### Responsible Party

**Investigator Affiliation:** Wolfson Medical Center

**Investigator Full Name:** Eran Horowitz M.D.

**Investigator Title:** Senior Physician

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief 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.

**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.

### Conditions Module

**Conditions:**

- Patient Participation

### Design Module

#### Bio Spec

**Description:** Blood samples evaluated for Anti Mullarin Hormone (AMH)

**Retention:** SAMPLES_WITHOUT_DNA

#### Design Info

**Observational Model:** CASE_CONTROL

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 90

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** First group patients who vaccinated and measure the AMH before and up to 9 months after vaccination.

**Intervention Names:**

- Biological: Vcinated

**Label:** Vaciinated

#### Arm Group 2

**Description:** Second group patients who were infected by Covid-19 ant therefor were not vaccinated

**Label:** Infected patients by covid-19 and not vacinated

#### Arm Group 3

**Description:** Ptients who who were not infected nor vacinated by Covid-19.

**Label:** Not infected nor vacinated

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Vaciinated

**Description:** Patients who were vacinated.

**Name:** Vcinated

**Type:** BIOLOGICAL

### Outcomes Module

#### Primary Outcomes

**Description:** Before and after vacination

**Measure:** Amh levels

**Time Frame:** 9 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Age 18-44

Exclusion Criteria:

Age over 45

**Gender Based:** True

**Gender Description:** Women in reproductive age.

**Healthy Volunteers:** True

**Maximum Age:** 44 Years

**Minimum Age:** 18 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** FEMALE

**Standard Ages:**

- ADULT

**Study Population:** Women who are going through IVF treatments.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** eranh7@gmail.com

**Name:** Eran Horowitz, M.D

**Phone:** +972-54-4991919

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Holon

**Contacts:**

***Contact 1:***

- **Email:** eranh7@gmail.com

- **Name:** Eran Horowitz, M.D

- **Phone:** 972-3-5028105

- **Role:** CONTACT

***Contact 2:***

- **Name:** Eran Horowitz, M.D

- **Role:** SUB_INVESTIGATOR

**Country:** Israel

**Facility:** Wolfson medical center

**Status:** RECRUITING

**Zip:** 58100

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M9789

- Name: Hormones

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
