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NCT00930501 Clinical Trial

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

Infertility Clinical Trial

— Ovrescancer  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00930501
Other study ID # 111222
Secondary ID
Status Recruiting
Phase N/A
First received June 28, 2009
Last updated June 29, 2009
Start date June 2009
Est. completion date December 2013

Study information
Verified date June 2009
Source Hadassah Medical Organization
Contact Ariel Revel, MD
Phone 97226776424
Email arielr2@hadassah.org.il
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date December 2013
Est. primary completion date December 2011
Accepts healthy volunteers No
Gender Female
Age group 5 Years to 45 Years
Eligibility Inclusion Criteria:

- all females prior and after chemotherapy

Exclusion Criteria:

- do not consent

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Biological:
• blood tests
time 0 is pretreatment time 3, 6 , 9, 12 months from the end of chemotherapy

Locations
Country Name City State
Israel Hadassah Jerusalem

Sponsors (1)
Lead Sponsor Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Anti mullerian hormone 2 years No
Secondary antral follicle count 2 years No
Secondary FSH 2 years No
Secondary inhibin b 2 years No
Secondary menstrual history 2 years No
Secondary E2 and prog 2 years No
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