NCT01143844

Assessing Fertility Potential in Female Cancer Survivors

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 391 (actual)
• Sponsor: University of Pennsylvania · Academic / Other
• Sex: Female
• Age: 11 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Hypothesis: Girls and women exposed to chemotherapy and/or radiation therapy experience endocrine changes more similar to women in their late reproductive years than to same-age peers. These changes will be more dramatic in women who receive high dose therapy compared to women who receive low dose therapy. At annual visits over 3-5 years, a combination of physical exam, medical history, menstrual diary keeping, pelvic ultrasound and blood hormones tests will be used to measure "ovarian reserve" , that is the number and quality of the eggs that remain in the ovaries. The study will also try to learn if those who received higher doses of certain chemotherapies are more likely to have changes in these tests sooner than those women who received smaller doses of these same drugs. Additionally a DNA (deoxyribonucleic acid) sample will be collected to look for gene variations that may predict susceptibility to ovarian damage from cancer treatments. Information learned from this study may help researchers to develop guidelines to identify problems with a female cancer survivor's ovaries before irregular menses or other symptoms of ovarian failure occur.

Detailed description

Up to 400 females will participate in this study in one of three cohorts: * 150 females ages 11-35, with history of exposure to alkylating agent chemotherapy and/or radiation therapy * 150 Unexposed peers, ages 11-35, never exposed to chemotherapy or radiation therapy * 100 Unexposed females, ages 40-50 never exposed to chemotherapy or radiation therapy

Conditions

• Effects of Chemotherapy

Timeline

• Start date: 2006-03-01
• Primary completion: 2020-03-30
• Completion: 2020-03-30
• First posted: 2010-06-14
• Last updated: 2021-04-13

Locations

2 sites across 1 country: United States