Treatment of Women With Different Phenotype of Polycystic Ovary Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Restoration of regular menstrual cycle
研究概览
简要总结
In this study, female patients diagnosed with polycystic ovary syndrome (PCOS) will be enrolled. In particular, those with elevated testosterone or with clinical signs of hyperandrogenism, along with menstrual cycle alterations and/or polycystic ovary morphology at ultrasound, will be included in the study.
Current treatments for PCOS include insulin sensitizers (such as metformin) and hormonal contraceptives. However, they are not devoid of side effects or may not be well tolerated, often leading to therapy discontinuation. Inositol represents a valid alternative to standard treatments, as it serves both as insulin sensitizer and as second messenger of FSH in the ovaries, thus regulating glucose metabolism and supporting ovarian function. The presence of two inositol isomers, namely myo-inositol and D-chiro-inositol, in defined ratios in human tissues suggests that supplementation with both would be ideal. Despite numerous evidence available, the ratio that gives the best clinical results is still debated.
In the present clinical trial, patients will be given a dietary supplement containing myo-inositol and D-chiro-inositol in two ratios (either 40:1 or 3.6:1, respectively) for three months. Restoration of regular menstrual cycle and of hormonal status will be the primary goal of the intervention.
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 45 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •PCOS according to the Rotterdam Criteria
- •Clinical or biochemical hyperandrogenism
排除标准
- •other causes of ovulatory disfunction (e.g., hyperprolactinemia or hypothyroidism)
- •other causes of hyperandrogenism (e.g., adrenal hyperplasia or Cushing's syndrome)
- •use of medications that influence ovulation
- •hormonal treatments
- •chronic pharmacological therapies
- •use of inositol-containing supplements
- •regular consumption of inositol-enriched food
研究组 & 干预措施
Treatment
Women with PCOS under oral supplementation with myo-inositol and D-chiro-inositol in 40:1 ratio
干预措施: Myo-Inositol and D-Chiro-Inositol (40:1) (Dietary Supplement)
Comparator
Women with PCOS under oral supplementation with myo-inositol and D-chiro-inositol in 3.6:1 ratio
干预措施: Myo-Inositol and D-Chiro-Inositol (3.6:1) (Dietary Supplement)
结局指标
主要结局
Restoration of regular menstrual cycle
时间窗: From enrollment (T0) to the completion of the study at 3 months (T3M)
Number (%) of patients with regular menstrual cycle at the end of the study
次要结局
- Hormonal status(From enrollment (T0) to the completion of the study at 3 months (T3M))
