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

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ClinicalTrials.gov Identifier: NCT00930501
Recruitment Status : Unknown
Verified June 2009 by Hadassah Medical Organization.
Recruitment status was:  Recruiting
First Posted : June 30, 2009
Last Update Posted : June 30, 2009
Information provided by:
Hadassah Medical Organization

Brief 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.

Condition or disease Intervention/treatment
Infertility Biological: blood tests

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
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Phase 1 Prospective Study of Markers of Ovarian Reserve in Young Female Cancer Patients
Study Start Date : June 2009
Estimated Primary Completion Date : December 2011
Estimated Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

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

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

Primary Outcome Measures :
  1. Anti mullerian hormone [ Time Frame: 2 years ]

Secondary Outcome Measures :
  1. antral follicle count [ Time Frame: 2 years ]
  2. FSH [ Time Frame: 2 years ]
  3. inhibin b [ Time Frame: 2 years ]
  4. menstrual history [ Time Frame: 2 years ]
  5. E2 and prog [ Time Frame: 2 years ]

Biospecimen Retention:   Samples Without DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 45 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
females 5-45 years old

Inclusion Criteria:

  • all females prior and after chemotherapy

Exclusion Criteria:

  • do not consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00930501

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

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

Responsible Party: Ariel Revel, MD, Hadassah
ClinicalTrials.gov Identifier: NCT00930501     History of Changes
Other Study ID Numbers: 111222
First Posted: June 30, 2009    Key Record Dates
Last Update Posted: June 30, 2009
Last Verified: June 2009

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

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