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临床试验/NCT02084940
NCT02084940Unknown不适用

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

Bioroma1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2014年3月最近更新:
适应症
干预措施
相关药物

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

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)

研究者

发起方
Bioroma
申办方类型
Other
责任方
Sponsor

研究点 (1)

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