Efficacy and Safety of Dexamethasone Prevention for Patients of Ovarian Hyperstimulation Syndrome -- A Prospective, Randomized, Controlled Clinical Trial
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Incidence of moderate and severe OHSS
研究概览
简要总结
This prospective, randomized, controlled clinical trial will evaluate the effect and security of dexamethasone prevention for Patients of Ovarian Hyperstimulation Syndrome.
详细描述
Ovarian hyperstimulation syndrome (OHSS) is a iatrogenic complication of ovarian stimulation,which in its severe form is associated with significant morbidity and can be life threatening. It is characterized by cystic enlargement of the ovaries and rapid fluid shifts from the intravascular compartment to the third space. It is thought that increased vascular permeability is the pivotal mechanism of OHSS pathophysiology. The administration of human chorionic gonadotrophin results in the release of vasoactive substance such as vascular endothelial growth factor that causes vasodilation and leakage of fluids. Glucocorticoids and their synthetic derivatives have an inhibitory effect on the VEGF gene expression in vascular smooth muscle cells. By reducing leukocytic infiltration and the release of inflammatory mediator, inhibiting vasodilation and preventing increases in vascular permeability, these agents can dampen the inflammatory response and prevent edema formation ,thus offering a potential therapeutic intervention for OHSS. Investigators have observed more than a hundred patients in clinical practice that low-dose dexamethasone has prevention action for patients in IVF cycles at high risk of OHSS. This clinical trial is designed to evaluate the effect and security of dexamethasone prevention for patients of Ovarian Hyperstimulation Syndrome. There are two groups: bromocriptine group, dexamethasone group .After followed-up for 7 days , Clinical OHSS parameters will be collected at oocyte retrieval and at the 4rd d and 6th d of treatment .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women of reproductive age
- •Women having controlled ovarian hyperstimulation as part of any assisted reproductive technique
- •Women at risk of severe OHSS(serum estradiol levels were>3000pg/ml on the day of HCG trigger ; there was retrieval of 20 or more oocytes)
排除标准
- •Unwillingness to comply with the study protocol.
- •Attending other clinical trials in the same period.
- •Chronic glucocorticoid their synthetic derivatives intake.
- •History of allergic to study medications.
- •The patients who cannot take dexamethasone.: hypertension, diabetes,gastric ulcer; abnormal renal or hepatic function and so on.
研究组 & 干预措施
bromocriptine group
Rectal bromocriptine (2.5 mg, qd) for 7 days
干预措施: bromocriptine (Drug)
dexamethasone group
Oral take dexamethasone(3mg,qd)for 7 days
干预措施: dexamethasone (Drug)
结局指标
主要结局
Incidence of moderate and severe OHSS
时间窗: 7 days
Moderate OHSS is characterized by the presence of ascites on ultrasound examination ,moderate hemoconcentration and elevated leukocytes.Symptoms include abdominal distension , nausea and vomiting . And diagnosis of severe OHSS required clinical evidence of ascites or hydrothorax or breathing difficulties or one of the following criteria: 1) increased blood viscosity i.e. hemoglobin at least 15 gm%, hematocrit at least 45%, or leucocyte count at least 20,000 per cubic millimeter. 2) coagulation abnormality.3) liver dysfunction, defined when transaminases (AST or ALT) are more than 40 u/ml.
次要结局
- Adverse side effects of treatment(7 days)
研究者
Yanhong Deng
Professor
Sun Yat-sen University
