NCT05034679

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 15, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 5, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2022

Completed
Last Updated

September 5, 2021

Status Verified

August 1, 2021

Enrollment Period

1.1 years

First QC Date

August 29, 2021

Last Update Submit

August 29, 2021

Conditions

Patient Participation

Outcome Measures

Primary Outcomes (1)

  • Amh levels

    Before and after vacination

    9 months

Study Arms (3)

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

VcinatedBIOLOGICAL

Patients who were vacinated.

Vaciinated

Eligibility Criteria

Age18 Years - 44 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen in reproductive age.
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Women who are going through IVF treatments.

You may qualify if:

  • Age 18-44

You may not qualify if:

  • Age over 45

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wolfson medical center

Holon, 58100, Israel

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples evaluated for Anti Mullarin Hormone (AMH)

MeSH Terms

Conditions

Patient Participation

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Central Study Contacts

Eran Horowitz, M.D

CONTACT

+972-54-4991919eranh7@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Physician

Study Record Dates

First Submitted

August 29, 2021

First Posted

September 5, 2021

Study Start

July 15, 2021

Primary Completion

August 15, 2022

Study Completion

October 15, 2022

Last Updated

September 5, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)