G-CSF(Granulocyte Colony Stimulating Factor) and Embryo Implantation and Pregnancy Following IVF (in Vitro Fertilization)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 129
- 试验地点
- 1
- 主要终点
- Embryo Implantation and Clinical Pregnancy Rates
研究概览
简要总结
This a trial designed to test whether granulocyte colony stimulating factor (G-CSF, Neupogen) can increase the rate of embryo implantation following IVF and embryo transfer. Preliminary data at the Center for Human Reproduction(CHR) and elsewhere suggest that intrauterine infusion of G-CSF can improve endometrial development and can increase implantation rates of embryos.
详细描述
Objective: To investigate the effect of treatment with CSF on pregnancy rates in routine in vitro fertilization (IVF).
Design: Double blinded crossover randomized controlled clinical trial
Setting: Academically affiliated private infertility centers
Subjects: Normal female IVF patients 18-38 years old, and above age 38 years, who are willing to be randomized to treatment.
Interventions: Subjects receive transvaginally, utilizing an insemination catheter, a slow uterine lavage with G-CSF (Neupogen), 300ug (in 1 ml); controls receive saline. Patients who do not conceive will, after one month washout time, continue treatment in the opposite study arm.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women already enrolled in an IVF cycle at one of the participating institutions
排除标准
- •Sickle Cell disease
- •Renal insufficiency
- •Upper respiratory infection or Pneumonia
- •Chronic Neutropenia
- •Known Past or present malignancy
研究组 & 干预措施
G-CSF then Saline
G-CSF (Granulocyte colony stimulating factor)
干预措施: G-CSF (Drug)
G-CSF then Saline
G-CSF (Granulocyte colony stimulating factor)
干预措施: Saline (Drug)
Saline then G-CSF
Normal Saline
干预措施: G-CSF (Drug)
Saline then G-CSF
Normal Saline
干预措施: Saline (Drug)
结局指标
主要结局
Embryo Implantation and Clinical Pregnancy Rates
时间窗: 26 to 30 days after embryo transfer
Implantation rate: The number of gestational sacs noted in the endometrial cavity 26 to 30 days after embryo transfer divided by the number of embryos transferred Clinical pregnancy: Gestational sac with evidence of a viable pregnancy at least 28 days after embryo transfer
次要结局
- Live Birth Rates(Within nine months of embryo transfer)
研究者
David H. Barad
Director of Clinical Research
Center for Human Reproduction