Assessing Fertility Potential in Female Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 391
- 试验地点
- 2
- 主要终点
- Reproductive hormones
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 11 Years 至 50 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •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.
结局指标
主要结局
Reproductive hormones
时间窗: Annually for 3-5 years
Primary Outcomes for this study will include mean and changes in reproductive hormone measures obtained during the early follicular phase of the menstrual cycle (days 1-4).
次要结局
- Antral Follicle Counts(Annually for 3-5 years)