Effects of Controlled Ovarian Hyperstimulation (COH) With Letrozole and Gonadotropin
Effects of Controlled Ovarian Hyperstimulation (COH) With Letrozole and Gonadotropin in Women at High Risk for Breast Cancer
Fertility drugs have the effect of increasing hormone levels. Higher hormone levels from infertility treatments may increase breast cancer risk, but there has not been enough research to know for sure. Researchers want to use a method of taking breast tissue cells from women who are having infertility treatment. The breast tissue cells might show changes that would indicate an increased risk of cancer. The method of taking the breast tissue cells is called Fine Needle Aspiration (FNA).
The purpose of this study is to examine the changes in breast tissue, in women at high risk of breast cancer who are being treated with controlled ovarian hyperstimulation.
研究概览
研究类型
注册 (实际的)
联系人和位置
学习地点
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Kansas
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Kansas City、Kansas、美国、66160
- The University of Kansas Medical Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion criteria:
Women must be at increased risk for breast cancer based on any of the following criteria:
- Age 30 or older with no prior live birth.
- Mutations associated with hereditary cancer (BRCA1 or 2, P53, PTEN)
- Family history of breast cancer including one first degree or multiple second degree relatives
- History of chest radiation before age 30
- Multiple prior breast biopsies
- Precancerous conditions (DCIS, LCIS, AH)
- Prior history of breast or ovarian cancer
- Estimated mammographic breast density > 50%
- Must be undergoing infertility treatment at the University of Kansas with Controlled Ovarian Hyper-stimulation (COH)
- Must be between the ages of 21-45 (both inclusive) with Day 3 FSH less than 12 IU/L, Day 3 E2 less than 80 pg/ml
Exclusion criteria:
- Women under 21 or over 45 years old
- Day 3 FSH over 12 IU/L, Day 3 E2 over 80 pg/ml
- Women who do not meet risk criteria above
- History of hypersensitivity to letrozole or gonadotropin
- Uterine and adnexal pathology
- Use of clomid or gonadotropin within 30days before the letrozole cycle
- Any severe chronic disease of relevance for reproductive function
学习计划
研究是如何设计的?
设计细节
队列和干预
团体/队列 |
干预/治疗 |
---|---|
Random Fine Needle Aspiration (RPFNA)
RPFNA
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
---|---|
evaluation with pre- and post-treatment(COH) breast cytomorphometry and biomarkers
大体时间:up to 12 months
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up to 12 months
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合作者和调查者
调查人员
- 首席研究员:Samuel Kim, MD、The University of Kansas Medical Center
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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