Use of Long Acting GnRH Antagonist to Prevent Ovarian HyperStimulation Syndrome (OHSS) in PCOS Women Undergoing COH for IVF
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- PREGNANCY RATE
研究概览
简要总结
In this study the effectiveness of degarelix, a long acting GnRH antagonist administered in a unique administration of 20 mg the first day of menstrual cycle, to prevent ovarian hyperstimulation syndrome (OHSS) in PCOS women at risk to develop OHSS.
详细描述
Women with PCOS are at risk to develop OHSS when stimulated with gonadotrophins for IVF. For this reason in this study the degarelix was tested in order to minimize the risk of OHSS as well as to improve the pregnancy rate in these patients. The use of long acting GnRH antagonist promotes a deep suppression of LH and consequently the activity of theca cells, which secrete androgens (the precursors of estradiol), and consequently the levels of estradiol remains low. Comparing the long acting GnRH antagonist at the first day of cycle with a flexible GnRH antagonist protocol in a group of patients with PCOS will be useful in order to establish the best way to perform controlled hyperstimulation in IVF cycles and minimize the risk of OHSS.
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 (Participant)
入排标准
- 年龄范围
- 20 Years 至 38 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women with PCOS
- •previous OHSS
- •Infertility
排除标准
- •more than 38 years old
- •Body mass index pore than 30
- •other systemic diseases
研究组 & 干预措施
degarelix group
group of patients treated with long acting GnRH antagonist
干预措施: degarelix (long acting GnRH antagonist) (Drug)
Cetrorelix 0.25mg
patients treated with gonadotropin and Cetrorelix ina flexible GnRH antagonist protocol
干预措施: cetrorelix 0.25mg (Drug)
结局指标
主要结局
PREGNANCY RATE
时间窗: 6 MONTHS
number of ongoing pregnancy obtained in the group
ovarian hyperstimulation syndrome rate
时间窗: 6 MONTHS
incidence of ovarian hyperstimulation syndrome in the groups
次要结局
- implantation rate(6 months)
研究者
Fabio Scarpellini
Principal Investigator
Centre for Endocrinology and Reproductive Medicine, Italy
