Assessing Fertility Potential in Female Cancer Survivors
Completed
Conditions studied: Effects of Chemotherapy
In brief
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.
Key facts
- Study ID
- NCT01143844
- Run by
- University of Pennsylvania
- People needed
- 391
- Starts
- 2006-03-01
- Expected to finish
- 2020-03-30
- Last updated by the study team
- 2021-04-13
Who can join
Age: 11 and older, up to 50. Sex: female. Healthy volunteers: accepted.
You may not qualify if…
- Current pregnancy.
- Use of hormonal contraception or use of hormone replacement therapy within the previous 4 weeks.
- Lactation within the previous 3 months.
- Chronic illness that would limit ability of participant to comply with study protocol.
- Any known medical condition, other than cancer, which in the judgement of the investigator is known to be associated with premature ovarian failure (such as Turner's Syndrome or Fragile X) or ovulatory dysfunction (such as thyroid disease, adrenal dysfunction, Cushing's syndrome, hyperprolactinemia, and polycystic ovarian syndrome).
- For controls, a history of infertility.
Where it is running
- Penn Reproductive Research Unit, 3701 Market Street, Suite 810 — Philadelphia, Pennsylvania, United States
- Penn Medicine at Radnor, 250 King of Prussia Road — Radnor, Pennsylvania, United States
Full record on ClinicalTrials.gov
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