NCT01315470Unknown1 期
Phase 1 Study of the Use of Granulocyte Colony-stimulating Factor for the Treatment of Repeated Implantation Failure in IVF Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- pregnancy rate
研究概览
简要总结
The investigators use granulocyte colony-stimulating factor (GCSF) for the treatment of recurrent implantation failure in IVF patient with cause unknown or due to thin endometrium. Several studies showed that GCSF improves embryo development and implantation and increase pregnancy rate.
详细描述
The investigators use granulocyte colony-stimulating factor (GCSF) for the treatment of repeated implantation failure (5 cycles) in IVF patient with cause unknown or due to thin endometrium. we intend to treat with GCSF during the IVF cycle if thin endometrium (<6 mm) is the cause for the treatment failure, and during the implantation window if cause unknown.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women after 5 failures in IVF cycles with cause unknown.
- •women after 5 failures in IVF due to thin endometrium (<6 mm) and unresponsive to estrogen supplements.
排除标准
- •history of hematology disease
- •allergy to GCSF
- •neutrophilia
- •severe lower back pain
- •liver dysfunction
- •hyperuricemia
- •a recent febrile disease or pneumonia
- •rheumatoid arthritis
- •sickle cell disease-
研究组 & 干预措施
neupogen
Experimental
干预措施: neupogen administration for women with recurrent IVF failure (Drug)
结局指标
主要结局
pregnancy rate
时间窗: 18 months
次要结局
- endometrial thickness during IVF treatment(18 months)
- endometrial thickness(18 months)
研究者
研究点 (1)
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