Anti-Mullerian Hormone (AMH) and Antral Follicle Count as Markers of Ovarian Reserve- Prospective Followup of Young Cancer Patients (Ovrescancer)

June 29, 2009 updated by: Hadassah Medical Organization

Phase 1 Prospective Study of Markers of Ovarian Reserve in Young Female Cancer Patients

young female cancer patients have improving chances of survival. the main risk is a chronic damage to their ovarian reserve. This may lead to future infertility.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

our objective is to prospectively follow patients before and after their cancer treatment. this should help us learn of the gonadotoxicity of various treatments as well as be able to better consult these and future patients of the need of fertility preservation techniques.

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Jerusalem, Israel
        • Recruiting
        • Hadassah

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 45 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

females 5-45 years old

Description

Inclusion Criteria:

  • all females prior and after chemotherapy

Exclusion Criteria:

  • do not consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cancer patients
women 5-45 yr olf pre and post chemotherapy
Biological: blood tests
time 0 is pretreatment time 3, 6 , 9, 12 months from the end of chemotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Anti mullerian hormone
Time Frame: 2 years
2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
antral follicle count
Time Frame: 2 years
2 years
FSH
Time Frame: 2 years
2 years
inhibin b
Time Frame: 2 years
2 years
menstrual history
Time Frame: 2 years
2 years
E2 and prog
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hadassah Medical Organization

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (ANTICIPATED)

December 1, 2011

Study Completion (ANTICIPATED)

December 1, 2013

Study Registration Dates

First Submitted

June 28, 2009

First Submitted That Met QC Criteria

June 29, 2009

First Posted (ESTIMATE)

June 30, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

June 30, 2009

Last Update Submitted That Met QC Criteria

June 29, 2009

Last Verified

June 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 111222

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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