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临床试验/NCT00617864
NCT00617864撤回不适用

The Effect of Human Albumin Infusion on VEGF Levels in Women at Risk for Ovarian Hyperstimulation Syndrome.

Yale University1 个研究点 分布在 1 个国家开始时间: 2007年9月最近更新:
适应症
干预措施
相关药物

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

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

Experimental

Group will receive infusion of human albumin

干预措施: Human Albumin Infusion (Drug)

2

Placebo Comparator

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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