Assessment of Ovarian Reserve in Female Cancer Survivors
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ClinicalTrials.gov Identifier: NCT01062542 |
Recruitment Status
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Active, not recruiting
First Posted
: February 4, 2010
Last Update Posted
: September 20, 2017
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Tracking Information | ||||
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First Submitted Date | January 21, 2010 | |||
First Posted Date | February 4, 2010 | |||
Last Update Posted Date | September 20, 2017 | |||
Study Start Date | September 2008 | |||
Estimated Primary Completion Date | April 2018 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
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Original Primary Outcome Measures | Same as current | |||
Change History | Complete list of historical versions of study NCT01062542 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Same as current | |||
Current Other Outcome Measures | Not Provided | |||
Original Other Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | Assessment of Ovarian Reserve in Female Cancer Survivors | |||
Official Title | Fertility in Female Cancer Survivors - Novel Assessment of Ovarian Reserve | |||
Brief Summary | Chemotherapy can damage the ovaries and cause premature menopause. In women treated before the age of 40 years, menopause does not usually occur. We have very little information about the impact of chemotherapy on ovarian function in this particular group of women. In this study, we will check hormone blood tests and ultrasound tests of the ovaries to measure the reserve of eggs left in the ovaries after treatment in young survivors of breast cancer and childhood cancer. We will do the same tests in our comparison group. We can use these results to estimate the reduction in fertility in young cancer survivors. | |||
Detailed Description | As women across North America and Europe increasingly delay childbirth, fertility preservation is emerging as an important issue among young breast cancer patients. The dramatic increase in survival for the major pediatric cancers in the last 50 years has resulted in an expanding population of childhood cancer survivors. The information currently available to counsel these patients about the impact of treatment on their fertility is inadequate. A significant degree of subfertility can exist prior to the onset of frank ovarian failure, and current studies do not address this. This study will adopt new technologies that have revolutionized the evaluation of female fertility to assess ovarian function in young breast cancer survivors. The results will provide new, more accurate and clinically useful information to patients and physicians about the impact of cancer therapy on fertility. The results have the potential to influence clinical decisions regarding cancer treatment, and the use of assisted reproductive technologies for contemporary patients and survivors. Further, insofar as treatment advances are designed to improve disease control while reducing toxicity, these results may serve as the basis for better understanding the toxicity of modern therapy and provide opportunities for improvement. |
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Study Type | Observational | |||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Non-Probability Sample | |||
Study Population | Patients are selected from their primary care clinic. | |||
Condition |
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Intervention | Procedure: Blood Draw and Ultrasound
Patients will have a Blood sample taken to check hormone levels. Patients will also have an ultrasound test done to examine the ovaries. The ultrasound test is done by inserting a cylindrical probe into the vagina. The test has to be done this way to measures the ovaries accurately. |
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Study Groups/Cohorts |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Active, not recruiting | |||
Estimated Enrollment |
210 | |||
Original Estimated Enrollment | Same as current | |||
Estimated Study Completion Date | April 2018 | |||
Estimated Primary Completion Date | April 2018 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years to 50 Years (Adult) | |||
Accepts Healthy Volunteers | Yes | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Canada | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT01062542 | |||
Other Study ID Numbers | UHN REB 08-0115-B | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | University Health Network, Toronto | |||
Study Sponsor | University Health Network, Toronto | |||
Collaborators |
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Investigators |
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PRS Account | University Health Network, Toronto | |||
Verification Date | September 2017 |