GnRH Antagonist in the Luteal Phase Compared to Conventional Treatment in Women With Severe Early Ovarian Hyperstimulation Syndrome (OHSS) in Whom All Embryos Are Cryopreserved
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Time to severe OHSS regression
研究概览
简要总结
The study aims to compare the novel method of GnRH antagonist administration in the luteal phase versus conventional treatment in IVF patients who develop severe early ovarian hyperstimulation syndrome and have all their embryos cryopreserved.
详细描述
GnRH antagonist administration in the luteal phase has been proposed as a strategy for the treatment of established severe early OHSS, causing rapid regression of the syndrome on an outpatient basis. The approach has been described as tertiary OHSS prevention, thereby complementing the primary prevention (GnRH antagonist protocol) and secondary prevention (GnRH agonist trigger) that constitute the OHSS-free clinic concept. No randomized controlled trials (RCT) exist to date comparing luteal GnRH antagonist administration versus conventional treatment.
The aim of the present study is to compare the novel method of GnRH antagonist administration in the luteal phase versus conventional treatment with primary outcome time to severe OHSS regression, in IVF patients who develop severe early OHSS and have all their embryos cryopreserved.
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
- 18 Years 至 49 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women with established severe early OHSS.
- •Criteria for the diagnosis of severe OHSS require:
- •the presence of moderate (or higher) ascites and at least two of the following:
- •enlarged ovaries (>100 mm maximal diameter),
- •haematocrit (Ht) >45%,
- •white blood cell count (WBC) >15,000/mm3.
排除标准
- •Women not fulfilling the above criteria
研究组 & 干预措施
Antagonist
0.25 mg GnRH antagonist cetrorelix will be administered once daily for 4 days, starting on the day of severe early OHSS diagnosis
干预措施: cetrorelix (cetrotide) (Drug)
Conventional
Women with severe early OHSS will be treated with conventional treatment, such as intravenous albumin administration, paracentesis of ascitic fluid, either on an outpatient or inpatient basis.
干预措施: Placebo (Drug)
结局指标
主要结局
Time to severe OHSS regression
时间窗: 2- 21 days after severe OHSS diagnosis
次要结局
- Need for patient hospitalization(2- 21 days after severe OHSS diagnosis)
- Hematocrit levels(8 days after severe early OHSS diagnosis)
- Quantity of ascites(8 days after severe early OHSS diagnosis)
- Estradiol levels(8 days after severe early OHSS diagnosis)
- White blood cells(8 days after severe early OHSS diagnosis)
- Diameter of ovaries(8 days after severe early OHSS diagnosis)
- Serum levels of vascular endothelial growth factor (VEGF)(8 days after severe early OHSS diagnosis)
- Progesterone levels(8 days after severe early OHSS diagnosis)