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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
Sponsor:
Information provided by:
Hadassah Medical Organization

Tracking Information
First Submitted Date June 28, 2009
First Posted Date June 30, 2009
Last Update Posted Date June 30, 2009
Study Start Date June 2009
Estimated Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 29, 2009)
Anti mullerian hormone [ Time Frame: 2 years ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: June 29, 2009)
  • antral follicle count [ Time Frame: 2 years ]
  • FSH [ Time Frame: 2 years ]
  • inhibin b [ Time Frame: 2 years ]
  • menstrual history [ Time Frame: 2 years ]
  • E2 and prog [ Time Frame: 2 years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Anti-Mullerian Hormone (AMH) and Antral Follicle Count as Markers of Ovarian Reserve- Prospective Followup of Young Cancer Patients
Official Title Phase 1 Prospective Study of Markers of Ovarian Reserve in Young Female Cancer Patients
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.
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
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
bloods
Sampling Method Non-Probability Sample
Study Population females 5-45 years old
Condition Infertility
Intervention Biological: blood tests
time 0 is pretreatment time 3, 6 , 9, 12 months from the end of chemotherapy
Study Groups/Cohorts Cancer patients
women 5-45 yr olf pre and post chemotherapy
Intervention: Biological: blood tests
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Unknown status
Estimated Enrollment
 (submitted: June 29, 2009)
100
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2013
Estimated Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • all females prior and after chemotherapy

Exclusion Criteria:

  • do not consent
Sex/Gender
Sexes Eligible for Study: Female
Ages 5 Years to 45 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Israel
Removed Location Countries  
 
Administrative Information
NCT Number NCT00930501
Other Study ID Numbers 111222
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Ariel Revel, MD, Hadassah
Study Sponsor Hadassah Medical Organization
Collaborators Not Provided
Investigators Not Provided
PRS Account Hadassah Medical Organization
Verification Date June 2009