Ovarian Tissue Cryopreservation for Fertility Preservation
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- Boston IVF
- 试验地点
- 4
- 主要终点
- Safety
研究概览
简要总结
To provide a novel fertility preservation option for patients facing a fertility threatening cancer diagnosis or treatment regimen by establishing an ovarian tissue cryopreservation program. To determine if ovarian tissue cryopreservation provides women with a useful, successful option for fertility preservation
The hypothesis is that ovarian tissue cryopreservation for fertility preservation provides an alternative option for fertility preservation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Will undergo surgery, chemotherapy, drug treatment and/or radiation for the treatment or prevention of a medical condition or malignancy which are likely to result in permanent loss of subsequent ovarian function or diminished fertility
- •Have a medical condition or malignancy that requires removal of all or part of one or both ovaries
- •Patients may have newly diagnosed or recurrent disease
- •Be in good health so as to be able to undergo laparoscopic surgery as determined by history and physical examinations, and consultation with the medical oncologist, reproductive endocrinologist, surgeon and anesthesiologist
排除标准
- •Moderate to high-risk of ovarian failure due to treatment
- •Documented ovarian metastasis
- •HIV or hepatitis (B, C)-positive serology
- •Absolute surgical contraindications
- •ECOG performance status of 0 or 1
- •Pregnancy
- •Women with psychological, psychiatric, or other conditions which prevent giving fully informed consent
结局指标
主要结局
Safety
时间窗: 10 years
Safety, which will be assessed by tracking the number of minor and major complications of the procedure including the following: * Minor: Local infection * Major: Blood loss requiring blood transfusion, major infection requiring admission or parental antibiotics, injury to surrounding organs requiring further procedures, hospitalization due to unforeseen operative complication
次要结局
- Efficacy(10 years)
研究者
David Ryley, MD
Reproductive Endocrinologist
Boston IVF