The Use of a Long Acting GnRH Antagonist (Degarelix) in Controlled Ovarian Hyperstimulation in PCOS Women at a Risk to Developing OHSS Undergoing IVF : a Pilot Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Pregnancy rate
研究概览
简要总结
PCOS is a common endocrinopathy affecting 5-10% of women in their reproductive age characterized by hyperandrogenism, chronic anovulation and polycystic ovaries. This syndrome is a serious problem in IVF since there is a high risk of developing ovarian hyperstimulation syndrome (OHSS) during ovarian stimulation with gonadotropins. The introduction of GnRH antagonist in IVF has reduced the incidence of severe OHSS, still maintaining a good ovarian response and pregnancy rate. Recently, a long acting GnRH antagonist, Degarelix, was introduced for prostatic cancer treatment. Furthermore a recent paper reported its use also for the induction of multiple follicular growth in a program of oocyte donation. The aim of this study is to evaluate the feasibility of GnRH antagonist depot use in a protocol of controlled ovarian hyperstimulation in PCOS women at risk of developing OHSS in IVF cycles.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 23 Years 至 37 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •regular menstrual cycle (26-39 days)
- •primary infertility
- •BMI < 30
排除标准
- •women with diabetes and other metabolic disease
- •women with heart disease
- •women with inflammatory or autoimmune disease
研究组 & 干预措施
GnRH antagonist depot, Degarelix
Women receive 20 mg of Degarelix on the first day of menstrual cycle followed by a fixed dose of 225 IU of recombinant FSH on the second day until the day of ovulation triggering
干预措施: GnRH antagonist depot Degarelix (Drug)
结局指标
主要结局
Pregnancy rate
时间窗: Time Frame: until 12th gestational week
Incidence of OHSS
时间窗: Time frame: until 7th gestational week
次要结局
- Number of collected oocytes(Time Frame: until 12th gestational week)
- Estradiol level at HCG day(time frame: until 12th gestational week)
- Total dose of FSH administered(Time frame: until 12th gestational week)
- Total days of stimulation(Time frame: until 12th gestational week)
- implantation rate(time frame: until 12th gestational week)
