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

This study is currently recruiting participants.
Verified June 2009 by Hadassah Medical Organization
Sponsor:
Information provided by:
Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT00930501
First received: June 28, 2009
Last updated: June 29, 2009
Last verified: June 2009
History of Changes
  Purpose

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.


Condition Intervention
Infertility
 Biological: blood tests

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Phase 1 Prospective Study of Markers of Ovarian Reserve in Young Female Cancer Patients

Resource links provided by NLM:

MedlinePlus related topics: Cancer Infertility
U.S. FDA Resources

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Anti mullerian hormone [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • antral follicle count [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • FSH [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • inhibin b [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • menstrual history [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • E2 and prog [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

bloods


Estimated Enrollment: 100
Study Start Date: June 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   5 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

females 5-45 years old

Criteria

Inclusion Criteria:

  • all females prior and after chemotherapy

Exclusion Criteria:

  • do not consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00930501

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

Locations
Israel
Hadassah Recruiting
Jerusalem, Israel
Contact: Ariel Revel, MD     97226776424     arielr2@hadassah.org.il    
Principal Investigator: Ariel Revel, MD            
Sponsors and Collaborators
Hadassah Medical Organization
  More Information

No publications provided

Responsible Party: Ariel Revel, MD, Hadassah
ClinicalTrials.gov Identifier: NCT00930501     History of Changes
Other Study ID Numbers: 111222
Study First Received: June 28, 2009
Last Updated: June 29, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Hadassah Medical Organization:
chemotherapy
cancer
AMH
 gonadotoxicity
ovarian reserve
patients exposed to chemotherapy

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 19, 2013