The Effect of Human Albumin Infusion on VEGF Levels in Women at Risk for Ovarian Hyperstimulation Syndrome.
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Serum VEGF levels
研究概览
简要总结
This research study was designed to look at the effect of human albumin transfusion on circulating levels of Vascular Endothelial Derived Growth Factor (VEGF), a protein that is believed to be responsible for the syndrome of ovarian hyperstimulation. Patients have been asked to participate because they are identified as at risk for the Ovarian Hyperstimulation Syndrome (OHSS), a potentially serious complication of in vitro fertilization. It has been established that the onset of OHSS may be preventable by the infusion of albumin at the time of egg retrieval; however, we do not know by what mechanism albumin works. As we know the pathogenesis of OHSS is related to VEGF released from the ovaries, we believe human albumin may serve to "bind up" this VEGF and prevent it from causing its harmful effects. The purpose of this study is to evaluate the effect of albumin infusion on blood and urine VEGF levels in these patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 42 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Infertile patients undergoing in vitro fertilization with or without ICSI
- •Estradiol > 3000 pg/mL at the time of hCG administration
- •>/= 20 follicles seen during ultrasound monitoring
- •Patients with polycystic ovarian syndrome
排除标准
- •Patients with only one ovary
- •Patients with medical contraindication to human albumin (hypersensitivity, hypervolemia, cardiac insufficiency, hypertension, esophageal varices, pulmonary edema, severe anemia, renal failure)
研究组 & 干预措施
1
Group will receive infusion of human albumin
干预措施: Human Albumin Infusion (Drug)
2
Group will receive infusion of saline
干预措施: Saline Infusion (Drug)
结局指标
主要结局
Serum VEGF levels
时间窗: Time surrounding egg retrieval
次要结局
- Urine VEGF levels(Time surrounding egg retrieval)
- Pregnancy(Time surrounding egg retrieval)
