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
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
-
-
-
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
|
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
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
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.