NCT01298960终止2 期
Phase II Randomized Study of Cotreatment With Growth Hormone in a Long GnRH Agonist Protocol in Women With Previous Poor Ovarian Response
Institut Universitari Dexeus1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2011年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Number of metaphase II oocytes retrieved
研究概览
简要总结
Experimental study to evaluate if rGH addition to a standard controlled ovarian stimulation treatment improves ovarian response in women with previous poor ovarian response.
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 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women who desire pregnancy with regular spontaneous menstrual cycles of 25-30 days length.
- •Infertility requiring IVF with or without ICSI.
- •Antecedent of a failed previous IVF cycle with a GnRH long agonist protocol in which at least 3000 IU of FSH were used (cancellation due to poor ovarian response - < 4 mature follicles - or less than 5 oocytes retrieved)and antral follicle count <
- •Partner sperm.
- •Presence of both ovaries and normal uterine cavity.
- •PAP smear within normality in previous 3 years.
- •Negative pregnancy test (serum or urine) before rFSH administration.
- •Willingness of adhesion to protocol during the whole study period.
- •Signed informed consent given.
排除标准
- •HIV, HCV, HBV positive serologies in women or partner.
- •Important systemic diseases that could interfere with gonadotrophin treatment (ovarian and hypothalamic tumors...).
- •BMI > 32 kg/m2 or antecedent of diabetes mellitus.
- •Gonadotrophin treatment within the previous 30 days.
- •Availability of frozen embryos of previous IVF cycles .
- •Abnormal uterine bleeding.
- •Previous treatment with LH or LH effect drugs.
- •Polycystic ovaries, increased size ovaries or presence of ovarian cysts of unknown ethiology.
- •Contraindication for pregnancy.
- •Allergies to gonadotrophins or somatotropin.
- •History of drug or alcohol abuse in the previous 5 years.
- •Previous enrollment in this study or simultaneous participation in another study with drugs.
研究组 & 干预措施
rGH Group
Experimental
干预措施: Somatropin (Drug)
结局指标
主要结局
Number of metaphase II oocytes retrieved
时间窗: 3 months after having finished recruitment
次要结局
- Pregnancy rate(9 months after ovum pick-up)
- Adverse events due to rGH(3 months after having finished recruitment)
研究者
Ignacio Rodriguez MSc
BSC
Institut Universitari Dexeus
研究点 (1)
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