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临床试验/NCT02846493
NCT02846493Unknown2 期

Efficacy and Safety of Dexamethasone Prevention for Patients of Ovarian Hyperstimulation Syndrome -- A Prospective, Randomized, Controlled Clinical Trial

Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2016年8月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

Rectal bromocriptine (2.5 mg, qd) for 7 days

干预措施: bromocriptine (Drug)

dexamethasone group

Experimental

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

发起方
Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Yanhong Deng

Professor

Sun Yat-sen University

研究点 (1)

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