NCT03985462撤回1 期
Autologous Very Small Embryonic-like Stem Cells(VSELs) for Premature Ovarian Failure
Fuda Cancer Hospital, Guangzhou1 个研究点 分布在 1 个国家开始时间: 2019年7月3日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Concentration of Blood female hormones level
研究概览
简要总结
The aim of this study is the safety and efficacy of autologous very small embryonic-like stem cells(VSELs) to premature ovarian failure.
详细描述
Premature ovarian failure is diagnosed by blood femal hormones test of follicle stimulating hormone (FSH, > 40 IU/L)、luteinizing hormon (LH, > 40 IU/L)、estradiol (E2, > 100pg/mL) and/or amenorrhea before the age of 40. VSELs come from the patient's periperal blood, and will be injected in bilateral oviducts, followed-up by hormone testing and menstrual conditions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
The number of patients enrolled and the number of injected cells were randomly selected by the investigator
入排标准
- 年龄范围
- 30 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients who are diagnosed as premature ovarian failure by professional doctor.
- •Those have clear abnormal sex hormone levels
排除标准
- •Unmarried woman
- •Suffering from other serious gynecological diseases or gynecological tumors
- •Blood disease patients, thrombocytopenia or dysfunction, hypofibrinemia or anticoagulant therapy, long-term use of aspirin
结局指标
主要结局
Concentration of Blood female hormones level
时间窗: 1 month after injection
Check whether blood FSH, LH and E2 levels return to normal
次要结局
- Incidence of amenorrhea(12 months after injection)
- Concentration of Blood female hormones level(12 months after injection)
研究者
研究点 (1)
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