NCT00795808已完成4 期
Multi-Centre Randomised Controlled Trial of the Effectiveness of Metformin and Clomiphene Citrate for Treating Anovulatory Infertility in Women With Polycystic Ovary Syndrome
University of Auckland, New Zealand1 个研究点 分布在 1 个国家目标入组 171 人开始时间: 2003年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 171
- 试验地点
- 1
- 主要终点
- Clinical pregnancy
研究概览
简要总结
- Metformin increases the pregnancy rate when added to the standard treatment of anovulatory polycystic ovary syndrome (PCOS).
- Metformin in combination with clomiphene, is more effective than clomiphene alone or metformin alone improves fertility outcomes in women with PCOS of reasonably healthy body weight (BMI </= 32).
- Metformin improves fertility outcomes in women with BMI > 32 with PCOS.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 39 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women between the age of 18 and 39 years inclusive.
- •Anovulatory infertility of duration at least 12 months.
- •Polycystic ovary syndrome, based on Rotterdam consensus criteria.
- •Normal serum prolactin, thyroid function and 17-hydroxyprogesterone.
- •Normal serum prolactin, thyroid function and 17-hydroxyprogesterone;
排除标准
- •Presence of any other significant infertility factor including male factor, known tubal disease or history of an ectopic pregnancy, known endometriosis affecting the fallopian tubes or ovaries.
- •Already taking oral hypoglycaemics.
- •Diabetics receiving treatment.
- •Renal impairment
- •Chronic hepatic disease
- •Cardiac Disease
- •Alcohol dependency
- •Pre-disposition to lactic acidosis
- •Previous ovarian drilling procedure, gonadotrophin injection therapy, IUI (intrauterine insemination) or IVF ( in vitro fertilisation).
- •For those women who have had previous fertility treatment, the following would be excluded:
- •Women who have had > 5 cycles of clomiphene citrate
- •Women who have had > 5 months metformin treatment previously
- •Women who have proven to be resistant to 100mg or more of clomiphene citrate.
研究组 & 干预措施
BMI > 32
Experimental
Women with BMI > 32
干预措施: Metformin (Drug)
BMI > 32
Experimental
Women with BMI > 32
干预措施: Placebo (Drug)
BMI </= 32
Experimental
Women with BMI </= 32
干预措施: Metformin + Clomiphene (Drug)
BMI </= 32
Experimental
Women with BMI </= 32
干预措施: Metformin (Drug)
BMI </= 32
Experimental
Women with BMI </= 32
干预措施: Clomiphene (Drug)
结局指标
主要结局
Clinical pregnancy
时间窗: within 6 calendar months of randomisation
次要结局
- Live birth
- Adverse events
研究者
研究点 (1)
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