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Assessing Fertility Potential in Female Cancer Survivors

2014-07-24 14:01:00 | BioPortfolio

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 5 years, a combination of physical exam, medical history, menstrual diary keeping, pelvic ultrasound and blood tests (FSH, Estradiol, AMH and Inhibin B) 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.

Participants ages 18-40 in this study will have the option of undergoing an additional, more sensitive test to assess their ovarian function. This test is called the clomiphene citrate (clomid) challenge test and involves taking clomiphene citrate for five days and having a repeat blood draw on the 10th day of the menstrual cycle.

Description

A total of 291 females will participate in this study: 3 groups with 97 women in each group.

- Cancer survivors, ages 15-40, who have been exposed to alkylating agent chemotherapy and/or radiation therapy

- Unexposed peers, ages 15-40, never exposed to chemotherapy or radiation therapy

- Late Reproductive Aged volunteers, ages 41-50 never exposed to chemotherapy or radiation therapy

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Conditions

History of Cancer

Location

Penn Reproductive Research Unit, 3701 Market Street, Suite 810
Philadelphia
Pennsylvania
United States
19104

Status

Recruiting

Source

University of Pennsylvania

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-24T14:01:00-0400

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