Impact of Myo-Inositol vs Combined Myo-Inositol and Metformin Therapy on Conception Rates, Treatment Adherence, and Tolerability in Overweight Women Diagnosed With PCOS: A Randomized Controlled Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Number of Participants with Confirmed Clinical Pregnancy by Ultrasound
研究概览
简要总结
The goal of this clinical trial (prospective randomized controlled trial) is to compare whether myo-inositol alone or in combination with metformin can improve conception rates, treatment compliance, and side-effect profiles in overweight women (BMI ≥25 kg/m²) diagnosed with polycystic ovary syndrome (PCOS).
The main questions it aims to answer are:
- Does myo-inositol alone achieve conception rates comparable to the combination of myo-inositol and metformin?
- Does the combination therapy result in more side effects and lower compliance compared to myo-inositol alone? If there is a comparison group: Researchers will compare Group A (myo-inositol 4 g/day) with Group B (myo-inositol 4 g/day + metformin 1500 mg/day) to see if the addition of metformin improves conception outcomes but at the cost of tolerability.
Participants will:
- Be randomly assigned to receive either myo-inositol alone or myo-inositol plus metformin for six months.
- Attend follow-up visits for monitoring of pregnancy outcomes confirmed by ultrasound.
- Report any side effects experienced during treatment.
- Provide information on treatment adherence and dropout rates.
- Be assessed for menstrual regularity and ovulation rates.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged 20 to 35 years
- •BMI ≥25 kg/m²
- •Fulfilled at least two of the three Rotterdam criteria for PCOS
- •Attempting to conceive naturally
- •No use of hormonal drugs or insulin-sensitizers in the past three months
排除标准
- •Endocrine disorders (e.g., diabetes, thyroid dysfunction)
- •Hepatic impairment
- •Kidney disease
- •Gastrointestinal or malabsorption issues (IBS, IBD, celiac disease)
- •Known allergies to metformin or inositol
- •Pregnant or breastfeeding
研究组 & 干预措施
arm 1
in the comparison group of study: Researchers will compare Group A (myo-inositol 4 g/day)
干预措施: Myoinositol (Drug)
arm 2
group B will be a combination group (Metformin 1500mg per day and Myo inositol 4gram per day)
干预措施: Myoinositol (Drug)
arm 2
group B will be a combination group (Metformin 1500mg per day and Myo inositol 4gram per day)
干预措施: Metformin 1500 mg daily (Drug)
结局指标
主要结局
Number of Participants with Confirmed Clinical Pregnancy by Ultrasound
时间窗: Up to 6 months or until pregnancy is confirmed
Clinical pregnancy defined as the presence of a gestational sac confirmed by ultrasound.
次要结局
未报告次要终点
研究者
Maria Amin
Postgraduate Resident Gynecology and Obstetrics
PAEC general hospital