Cabergoline Versus GnRH Antagonist Rescue and Cabergoline in the Prevention of Ovarian Hyperstimulation Syndrome: a Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 236
- 试验地点
- 1
- 主要终点
- Moderate or severe ovarian hyperstimulation syndrome
研究概览
简要总结
The aim of study is to compare the efficacy of GnRH antagonist rescue combined with cabergoline with cabergoline in the prevention of ovarian hyperstimulation syndrome in high risk patients undergoing ovarian stimulation for IVF-ET with long GnRH agonist protocol.
详细描述
Ovarian hyperstimulation syndrome (OHSS) is the most serious complication of assisted reproduction. Complications of OHSS include vascular thrombosis, pulmonary embolism, renal failure, electrolyte disturbances, ascites, hydrothorax ,torsion of the ovary, abortion or rarely death.
Previous studies revealed that converting a long GnRH agonist cycle to an GnRH antagonist cycle (GnRH antagonist rescue) reduced the risk of OHSS. Other studies revealed that cabergoline (potent dopamine receptor agonist on D2 receptors)was effective in preventing OHSS.
The aim of study is to compare the efficacy of GnRH antagonist rescue combined with cabergoline with cabergoline in the prevention of ovarian hyperstimulation syndrome in high risk patients undergoing ovarian stimulation for IVF-ET with long GnRH agonist protocol.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing ovarian stimulation for IVF-ET with long GnRH agonist protocol and at high risk of developing OHSS [ have more than 20 follicles ( 90% of them less than 14 mm in mean diameter) and serum estradiol ≥ 3000 pg/ml]
排除标准
- •Fibrosis of lung,
- •swelling or inflammation around the heart or lung,
- •hypertension,
- •liver disease,
- •heart valve disease and
- •allergy to cabergoline or ergot derivatives.
研究组 & 干预措施
Cabergoline group
Cabergoline is administered starting on the day of HCG administration.
干预措施: Cabergoline (Drug)
GnRH antagonist rescue & cabergoline group
Converting a long GnRH agonist cycle to an GnRH antagonist cycle (GnRH antagonist rescue) and Cabergoline is administered starting on the day of HCG administration.
干预措施: GnRH antagonist rescue & cabergoline (Drug)
结局指标
主要结局
Moderate or severe ovarian hyperstimulation syndrome
时间窗: Within 4 weeks of HCG adminstration
次要结局
- The Number of Participants Who Achieved Ongoing Pregnancy(18 weeks after embryo transfer)
研究者
Prof .Usama M.Fouda
M.D , PhD
Aljazeera Hospital