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
- 2
- 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
研究组 & 干预措施
Ovarian tissue cryopreservation
The ovarian tissue is cryopreserved and stored at Boston IVF, which is an FDA compliant and American Association of Tissue Banks accredited long term storage facility for reproductive tissue.
干预措施: Frozen ovarian tissue (Other)
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