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

Verified by: Hadassah Medical Organization, June 2009
First Received: June 28, 2009 | Last Updated: June 29, 2009 | Phase: N/A | Start Date: June 2009
Overall Status: Recruiting | Estimated Enrollment: 100
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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...

Brief Summary

Official Title: “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 Type: Observational
  • Study Design: Observational Model: Case-Only, Time Perspective: Prospective
  • Study Primary Completion Date: December 2011

Detailed Clinical Trial 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.

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

  • : Cancer patients
    • women 5-45 yr olf pre and post chemotherapy

Outcome Measures for this Clinical Trial

Primary Measures

  • Anti mullerian hormone
    • Time Frame: 2 years
      Safety Issue?: No

Secondary Measures

  • antral follicle count
    • Time Frame: 2 years
      Safety Issue?: No
  • FSH
    • Time Frame: 2 years
      Safety Issue?: No
  • inhibin b
    • Time Frame: 2 years
      Safety Issue?: No
  • menstrual history
    • Time Frame: 2 years
      Safety Issue?: No
  • E2 and prog
    • Time Frame: 2 years
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • all females prior and after chemotherapy

Exclusion Criteria:

  • do not consent

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 5 Years

Maximum Age for this Clinical Trial: 45 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Hadassah Medical Organization Other

Overall Clinical Trial Officials and Contacts

Overall Contact: Ariel Revel, MD 97226776424 arielr2@hadassah.org.il

Additional Information

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00930501

Study ID Number: 111222

ClinicalTrials.gov Identifier: NCT00930501

Health Authority: United States: Institutional Review Board

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