Comparative Study of Metformin Versus Myo-Inositol with D-chiro-Inositol on the Clinical, Hormonal and Metabolic Profiles in infertile women with PCOS: An Open-Label Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 220
- 试验地点
- 1
- 主要终点
- To assess the effect of metformin and myoinositol+ d-chiro inositol on meta-bolic parameter - HOMA IR in infertile women with PCOS.
研究概览
简要总结
Polycystic Ovary Syndrome is a prevalent endocrine disorder affecting women of reproductive age, characterized by a combination of clinical, hormonal, and metabolic abnormalities, including hyperandrogenism, ovulatory dysfunction, and insulin resistance.
Metformin, an insulin-sensitizing drug has been shown to improve insulin resistance, reduce androgen levels, and promote ovulation in women with PCOS. Despite its efficacy, metformin is associated with gastrointestinal side effects, leading to the exploration of alternative therapies
Myo-inositol and D-chiro-inositol, naturally occurring compounds involved in insulin signaling, have emerged as promising alternatives to metformin. These inositols, particularly when used in combination, are thought to improve insulin sensitivity, restore hormonal balance, and regulate menstrual cycles in women with PCOS. Several studies suggest that the combination of MI and DCI can positively influence the metabolic and reproductive profiles of PCOS patients, with fewer side effects compared to pharmacological treatments like metformin.
However, direct comparisons between metformin and the MI/DCI combination are limited. Most of the studies are not randomized with few sample size or having heterogeneous population. This study aims to fill this gap by comparing the effects of metformin and MI/DCI on the clinical, hormonal, and metabolic profiles of women with PCOS, providing crucial data to guide more effective and tolerable treatment options.
In infertility clinic and OPD, after diagnosis of PCOS and informed consent baseline investigations like clinical, metabolic and hormonal parameters are done along with baseline TVS scan and PCOSQOL scale. Patients will be randomized to either the interventional group or the control group . Study group will be treated with myoinositol and d-chiro inositol 2255 mg OD for 3 months. The control group will be treated with metformin 500 mg BD for 3 months. Subjects will be called for follow up visits at 4 weeks, 8 weeks and 12 weeks. At Every follow up visit, counselling sessions, adherence and side effects are noted. After the last visit all parameters- clinical, metabolic and hormonal will be checked and quality of life using PCOSQOL scale will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 21.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •All infertile women with PCOS (Diagnosed according to Rotter-dam’s criteria) attending the infertility clinic/OPD at Women and Children Hospital, JIPMER: 1)Age of the Women: between 21 to 35 years 2) Women with PCOS according to Rotterdam 2003 criteria 3) Willing for regular follow-up.
排除标准
- •A woman who is a known case of 1) Thyroid disorders 2) Congenital adrenal hyperplasia 3) Adrenal tumors 4) Cushing syndrome 5) Presence of any chronic diseases eg; diabetes mellitus, Chronic kidney disease, liver disease, etc.
- •Women who are allergic to metformin or inositols 7) Patient on metformin therapy 8) Women on steroid therapy or Oral contraceptive pills usage for within three months.
结局指标
主要结局
To assess the effect of metformin and myoinositol+ d-chiro inositol on meta-bolic parameter - HOMA IR in infertile women with PCOS.
时间窗: from the day of entry to study and follow up visits at 4 weeks, 8 weeks and 12 weeks
次要结局
- To determine and compare the effects of Metformin and myoinositol with d-chiro inositol on(- Clinical parameters, Hormonal parameters, Metabolic parameters, USG parameters, Quality of life- PCOSQOL scale)