Combination Therapy With Myo-inositol and Folic Acid Versus Myo-inositol Alone: Effects of Six Months Treatment on Clinical, Endocrine and Metabolic Features in Obese Women With Polycystic Ovary Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- number of cycles in six months of therapy
研究概览
简要总结
Previous studies have demonstrated that Myo-inositol is capable of restoring spontaneous ovarian activity, and consequently fertility, in most patients with PCOS. The aim of our study is to investigate the role of folic acid conteined in the inositol preparation. The study group included 50 patients, randomly allocated to subgroup A (myo-inositol 1500 gr) and subgroup B (myo-inositol 2000 gr + folic acid 200 mcg). The investigation include menstrual pattern and hirsutism score evaluation, hormonal assays, oral glucose tolerance test, euglycemic hyperinsulinaemic clamp and lipide profile at baseline and after six months of treatment.
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 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •women with PCOS diagnosed in accordance with Rotterdam Consensus Conference Criteria 2003
- •BMI > 25 kg/m2
- •age 18-35 years
排除标准
- •pregnancy
- •significant liver or renal impairment
- •other hormonal dysfunctions (hypothalamic, pituitary, thyroidal or adrenal causes for the clinical signs)
- •neoplasms
- •unstable mental illness
- •diagnosis of diabetes mellitus or impaired glucose tolerance
- •use of drugs able to interfere with gluco-insulinaemic metabolism for at least three months prior entering the study.
研究组 & 干预措施
myo-inositol 1500 gr
6 months treatment with myo-inositol 1500 gr
干预措施: myo-inositol 1500 gr (Drug)
myo-inositol 2000gr + folic acid 200 mcg
干预措施: myo-inositol 2000 gr + folic acid 200 mcg (Drug)
结局指标
主要结局
number of cycles in six months of therapy
时间窗: 6 months
We'll estimate the efficacy of the two treatments on the ovarian function and menstrual pattern.
次要结局
- effects oon lipide profile(6 months)
- effects on oral glucose tollerance test(six months)
- effects on hoormonal assay(6 months)
研究者
Maurizio Guido
medical doctor
Catholic University of the Sacred Heart