Insulin Sensitizing Agent (Metformin) Improves Clinical Pregnancy Rate and Insulin Parameters in Polycystic Ovarian Syndrome Patients With Acanthosis Nigricans
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 66
- 主要终点
- Pregnancy rate
研究概览
简要总结
Polycystic ovary syndrome (PCOS) is the most common Female endocrine disorder , with a prevalence ranging between 6% to10% based on the National Institutes of Health (NIH) criteria and when the broader Rotterdam criteria are applied it reaches as high as 15%. Typically, PCOS can identify during the early adolescence. Insulin resistance is a common finding in the obese women with PCOS. It is most prevalent and severe in PCOS phenotype involving hyperandrogenism and chronic anovulation. Women with PCOS who have regular cycles are metabolically less abnormal. Acanthosis nigricans (AN) is a dermatosis characterized by velvety, papillomatous, brownish-black, hyperkeratotic plaques, typically of the intertriginous surfaces and neck. Although AN is associated with malignancy, the recognition of its more common connection to obesity and insulin resistance allows for diagnosis of related disorders including type 2 diabetes, the metabolic syndrome, and polycystic ovary syndrome. Significant improvements in ovulation and pregnancy rates as a result of clomiphene treatment after metformin in women with clomiphene-resistant PCOS were reported in a popular randomized, double-blind, placebo-controlled trial . The first pharmacological approach to induction of ovulation in women with PCOS is clomiphene citrate
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 40 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •All patients with PCOS fulfilled at least 2 out of the three criteria of Rotterdam consensus 2003
排除标准
- •liver disease
- •heart or respiratory failure
- •alcohol abuse
- •kidney disease
研究组 & 干预措施
CC with placebo
100 mg clomiphene Citrate (Clomid , global Napi , Egypt) CC tablets taken from day 3 to day 7 of the cycle with placebo tablets taken twice daily continuously for three cycles.
干预措施: CC (Drug)
CC with placebo
100 mg clomiphene Citrate (Clomid , global Napi , Egypt) CC tablets taken from day 3 to day 7 of the cycle with placebo tablets taken twice daily continuously for three cycles.
干预措施: Placebo tablets (Drug)
CC plus Metformin
received t100 mg clomiphene Citrate (Clomid , global Napi , Egypt) CC tablets taken from day 3 to day 7 of the cycle with plus Metformin 500 mg twice daily continuously for three cycles.
干预措施: CC (Drug)
CC plus Metformin
received t100 mg clomiphene Citrate (Clomid , global Napi , Egypt) CC tablets taken from day 3 to day 7 of the cycle with plus Metformin 500 mg twice daily continuously for three cycles.
干预措施: Metformin (Drug)
结局指标
主要结局
Pregnancy rate
时间窗: 6 months
次要结局
- Fasting glucose (mg/dl)(6 months)
- Fasting insulin (mg/dl)(6 months)
