Long Term Effects of Tyrosine Kinase Inhibitors on Ovarian Reserve and Fertility, A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Changes in markers of ovarian reserve in premenopausal women undergoing tyrosine kinase inhibitor therapy for cancer
研究概览
简要总结
This pilot research trial studies the long term effects of tyrosine kinase inhibitor therapy on ovarian reserve and fertility in patients with chronic myeloid leukemia or gastrointestinal stromal tumor. Studying ovary imaging, ovarian reserve markers, and hormone levels from patients receiving tyrosine kinase inhibitor therapy may help doctors learn more about the effects of tyrosine kinase inhibitor therapy on ovarian function and fertility.
详细描述
PRIMARY OBJECTIVES:
I. To collect preliminary information to help design a study to look at longitudinal changes in markers of ovarian reserve and menstruation in premenopausal women undergoing tyrosine kinase inhibitors (TKI) therapy.
SECONDARY OBJECTIVES:
I. Evaluate ovarian response to controlled ovarian hyperstimulation in patients who elect to undergo in vitro fertilization (IVF) for fertility preservation.
OUTLINE:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with chronic myeloid leukemia (CML), gastrointestinal stromal tumor (GIST), non metastatic cancer where TKI is the first line agent
- •Premenopausal (has had menses at any time in the preceding 12 consecutive months)
- •Has not undergone a hysterectomy or bilateral oophorectomy
- •Willing to use non-hormonal (ie: barrier method or abstinence) as form of contraception during the one year of study
排除标准
- •Patients who have had chemotherapy or radiotherapy in the past
- •Patients may not be receiving any other investigational agents
- •Patients must not be pregnant or nursing
- •Other medical conditions or treatments that affect hormonal levels (potentially confounding interpretation of results)
- •Patients with ongoing hormonal contraception or unwilling or unable to discontinue will not eligible
结局指标
主要结局
Changes in markers of ovarian reserve in premenopausal women undergoing tyrosine kinase inhibitor therapy for cancer
时间窗: Baseline to up to 1 year
Standard descriptive statistics and scatter plots will be used to summarize patterns by cohorts at each time point. Regression methods will be used to render data compatible with the assumption of the normal distribution. Analysis will be undertaken to obtain preliminary estimates of ovarian reserve over time and to elucidate whether TKI therapy produces a clinically meaningful change in ovarian reserve marker.
次要结局
- Ovarian response to controlled ovarian hyperstimulation in patients who elect to undergo IVF for fertility preservation(Up to 1 year)