Intrauterine G-CSF Administration in Recurrent Implantation Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 157
- 试验地点
- 1
- 主要终点
- Clinical pregnancy rate
研究概览
简要总结
Aim of this study is to investigate the effects of intrauterine G-CSF on endometrial thickness, clinical pregnancy rate and live birth rate in a recurrent implantation failure (RIF) group
详细描述
This study was designed as a prospective randomized controlled trial with the involvement of 200 RIF group patients.The procedure will perform by administering 30 mIU of Leucostim®(Filgrastim [G-CSF] 30mIU/mL; DEM Medical, Dong-A; South Korea) through slow infusion into the endometrial cavity using a soft embryo transfer catheter. Normal saline of 1 mL will be infused into the endometrial cavity in the same way in the control group. The standard ICSI procedure will use for all patients, and fresh cycle embryos will be transferred on the third or fifth day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- 是
入选标准
- •Women under the age of 40 who met the RIF definition
- •Follicle-stimulating hormone (FSH) levels were <15 IU/mL
排除标准
- •Patients with congenital uterine anomalies
- •Patients with Asherman's syndrome
- •Patients with uterine cavity distorted by myoma or endometrial polyps
- •Patients with confirmed endometriosis or endometrioma
- •Patients for whom G-CSF was contraindicated (active infections, kidney disease, sickle cell anemia, malignancies, chronic neutropenia)
研究组 & 干预措施
G-CSF
Patients in the G-CSF group will receive G-CSF once a day on hCG day, before hCG injection. The procedure involved the administration of G-CSF through slow infusion into the endometrial cavity using a soft embryo transfer catheter.
干预措施: G-CSF (Drug)
Control group
Normal saline of 1 mL was infused into the endometrial cavity in the same way in patients in the control group
干预措施: Saline (Other)
结局指标
主要结局
Clinical pregnancy rate
时间窗: 1month
Gestational sac in USG per embryo transfer
次要结局
- Endometrial thickness(1month)