Filgrastim for Treatment of Premature Ovarian Insufficiency: Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 10
- 主要终点
- Return of menses
研究概览
简要总结
Filgrastim is a Granulocyte-Colony Stimulating factor (G-CSF). It is an FDA approved drug. Very small embryonic-like stem cells (VSELs) are found in the ovary. Animal studies showed that these cells are able to regenerate the affected ovary. Studies on mice have shown that Filgrastim result in recovery of oogenesis after chemotherapy-induced gonadal failure (in 2013, 2014, and 2015).
详细描述
Premature ovarian insufficiency (POI) has no curative treatment until now. Filgrastim is an FDA approved Granulocyte-Colony Stimulating factor (G-CSF). Very small embryonic-like stem cells (VSELs) are found in the testis and ovary. VSELs are stem cells that have noticed to survive chemotherapy induced gonadal failure. Data from animal studies showed that stimulation of these stem cells result in generation of the affected gonads. Studies on mice have shown a promising stimulating effect of Filgrastim on recovery of spermatogenesis and oogenesis after chemotherapy-induced gonadal failure (in 2013, 2014, and 2015).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 16 Years 至 40 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women with Premature Ovarian Insufficiency (POI): For the purpose of the research women is considered to have POI if she is aged less than 40 years and has amenorrhea of at least 4 month with FSH level above 25 IU/L (repeated twice >4 weeks apart).
排除标准
- •Abnormal karyotype
- •Previous pelvic or abdominal radiotherapy
- •Previous surgical removal of the ovarian pathology
- •Chronic disease: renal, liver, cardiac, malignancy
研究组 & 干预措施
Filgrastim arm
Intervention: Filgrastim vial (30 million IU/ml) SC injection twice daily for five consecutive days
干预措施: Filgrastim (Biological)
Placebo arm
Intervention: Injection of saline SC injection twice daily for five consecutive days.
干预措施: Saline (Drug)
结局指标
主要结局
Return of menses
时间窗: 6 months
Return of menses in patients with amenorrhea of at least 4 months
次要结局
- Pregnancy(6 months)
- serum Estradiol(6 months)
- serum Anti-mullarian Hormone (AMH)(6 months)
- serum FSH(6 months)
- Follicular growth(6 months)
- endometrial thickness(6 months)
研究者
Mohammad Abdel-Rahman Mohammad Ahmed
Doctor
South Valley University