Impact of Corona Vaccination on AMH- Anti Mullerian Hormone | NCT05034679

Studies
Impact of Corona Vaccination on AMH- Anti Mullerian Hormone

NCT05034679

Sponsor

Wolfson Medical Center

Status

Unknown status

Last Update Posted

Sep 5, 2021Actual

Enrollment

90Estimated

Phase

Not provided

Conditions

Patient Participation

Interventions

Vcinated

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 15, 2021Actual

Primary Completion Date

Aug 15, 2022Estimated

Completion Date

Oct 15, 2022Estimated

First Submitted Date

Aug 29, 2021

First Submission Date that Met QC Criteria

Aug 29, 2021

First Posted Date

Sep 5, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 29, 2021

Last Update Posted Date

Sep 5, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

90Estimated

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
Vaciinated	First group patients who vaccinated and measure the AMH before and up to 9 months after vaccination.	Biological: Vcinated
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.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vcinated	Biological	Patients who were vacinated.	Vaciinated

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18-44

Exclusion Criteria:

Age over 45

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Women in reproductive age.

Minimum Age

18 Years

Maximum Age

44 Years

Standard Ages

Adult

Study Population

Women who are going through IVF treatments.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Eran Horowitz, M.D	Contact	+972-54-4991919		eranh7@gmail.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Wolfson medical center	Recruiting	Holon		58100	Israel

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010358	Patient Participation

Ancestor Terms

ID	Term
D010342	Patient Acceptance of Health Care
D000074822	Treatment Adherence and Compliance
D015438	Health Behavior
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided