Ovarian Reserve Testing in Female Young Adult Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Return of menses
研究概览
简要总结
Young adult cancer survivors constitute an under served population to whom fertility potential is particularly important. For female young adult patients, cancer treatment such as alkylating chemotherapy are toxic to the finite number of eggs they have, resulting in risks of infertility and premature menopause related to ovarian failure. Reproductive issues are a major concern for young cancer survivors, but one that is understudied. Young cancer survivors have few tools to measure post-treatment ovarian reserve, or the quantity and quality of remaining eggs4. Accurate determination of ovarian reserve and fertility potential would not only be an important research tool, but also directly impact clinical management. The purpose of this study is to test if basal and provocative ovarian reserve testing can predict return of menses in female young adult cancer survivors, to compare basal and provocative ovarian reserve testing results between female young adult cancer survivors and healthy controls, and to compare basal and provocative ovarian reserve testing results between female young adult cancer survivors on and off of combined estrogen and progesterone hormone products.
Participants will be asked to keep track of their periods over three months. If a participant is taking birth control pills, patches, or vaginal ring, they will asked to come off the birth control for 3 months. Participants will also be asked to undergo ovarian reserve testing by blood draws and pelvic ultrasounds at the start and end of the 3 months.
详细描述
Same as brief summary
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Postmenarchal
- •Cancer diagnosis
- •Prior exposure to gonadotoxic therapy, inclusive of chemothearpy, pelvic or total body irradiation, unilateral oophorectomy
- •A minimum of 1 year since completion of gonoadotoxic therapy
- •Intact uterus
- •At least one ovary
排除标准
- •Estrogen receptor positive cancers
研究组 & 干预措施
Basal Testing
干预措施: recombinant FSH (Drug)
结局指标
主要结局
Return of menses
时间窗: 3 months
Self reported via bleeding calenders
次要结局
- Blood levels of FSH(3 months)
- Blood levels of AMH(3 months)
- Blood levels of estradiol(3 months)
- Blood levels of inhibin B(3 months)
研究者
Hui-Chun Irene Su
Assistant Professor of Reproductive Medicine
University of California, San Diego
