NCT01870752招募中不适用
Autologous Orthotopic Transplantation of Previously Cryopreserved Ovarian Tissue
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Return of menstrual function
研究概览
简要总结
Chemotherapy and radiation therapy for the treatment of cancer can compromise fertility. Ovarian tissue cryopreservation is an experimental strategy offered at The University of Pennsylvania to preserve future fertility (protocol 806062). The primary objective of this study is to determine the efficacy and safety of autologous transplantation of previously cryopreserved ovarian cortical tissue in patients who experience infertility or ovarian insufficiency after cancer treatments.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patient between the ages of 18 and 45 years
- •Previously cryopreserved and stored cortical ovarian tissue available for autologous transplantation
- •Ovarian insufficiency defined as an elevated FSH over 10
- •Inability to conceive after 6 months of unprotected intercourse with male
- •Reasonably good health
- •Candidate for pregnancy
- •Written clearance for the procedure from the patients oncologist
排除标准
- •Patients considered to be high risk for surgical complications will be excluded from the research protocol
- •Women who are known to be positive for the BRCA mutation
- •Women with a history of leukemia, ovarian cancer or a cancer that likely involved the ovaries at the time of ovarian tissue collection
- •Women with psychological, psychiatric, or other conditions which prevent giving fully informed consent
- •Current pregnancy
结局指标
主要结局
Return of menstrual function
时间窗: 5 years
Pregnancy
时间窗: 5 years
次要结局
- Surgical Complications of ovarian tissue transplantation(5 years)
- Cancer recurrence(5 years)
- Acceptability(5 years)
研究者
研究点 (2)
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