Usefulness of GnRH Antagonist Administration in the Treatment of Early Ovarian Hyperstimulation Syndrome
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Ultrasound
研究概览
简要总结
The aim of this study is to analyze the effectiveness of GnRh antagonist in the treatment of early ovarian hyperstimulation syndrome.
详细描述
Ovarian hyperstimulation syndrome (OHSS) is a serious complication of ovarian stimulation protocols. Gonadotrophin-releasing hormone (GnRH) antagonist administration in the luteal phase was recently proposed as a new approach for the management of patients with established severe OHSS We analyze the response of egg donors with moderate- severe early ovarian hyperstimulation syndrome after a GnRH antagonist stimulation protocol to the administration of a daily doses of GnRH antagonist (Cetrorelix 0.25) during 7 days after the second day of oocyte retrieval compared with placebo (saline solution).
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Egg donors
- •Volunteers.
- •18-35 years old
- •BMI < 30
- •OHHS after oocyte retrieval defined as ascitis > 9 cm2 associate to abdominal pain, sickness, abdominal distention,or haematocrit (Ht) >45% an white blood cell count >15,000/mm3 or creatine > 1.2 mg/dl or transaminases > 40 IU/liter
排除标准
- •BMI > 30
- •Allergy to GnRH antagonist
研究组 & 干预措施
GnRH antagonist
• GnRH antagonist (Cetrorelix 0.25)
干预措施: GnRH antagonist (Cetrorelix) (Drug)
Placebo (saline solution)
• Placebo (saline solution)
干预措施: Placebo (saline solution) (Drug)
结局指标
主要结局
Ultrasound
时间窗: one week
Ultrasound measurements: ascitis and ovarian size
Blood measurements
时间窗: one week
Blood measurements: hyperstimulation biomarkers, liver and kidney function and hormonal profile.
次要结局
未报告次要终点
研究者
Juan Giles
Principal Investigator; Gynecologist IVI Valencia
Instituto Valenciano de Infertilidad, IVI VALENCIA