Efficacy of Alpha Lipoic Acid Combined With Myo-Inositol in Non-Diabetic PCOS Patients

A Randomized Controlled Trial Evaluating the Efficacy of Alpha Lipoic Acid Combined With Myo-Inositol With or Without Metformin in Non-Diabetic Women With Polycystic Ovary Syndrome

This study evaluates the efficacy of alpha-lipoic acid combined with myo-inositol, with or without metformin, in improving menstrual regularity and ovulation in non-diabetic women with polycystic ovary syndrome (PCOS). The study also assesses metabolic, hormonal, and clinical outcomes.

This is a prospective randomized controlled parallel-group clinical trial evaluating the effects of alpha-lipoic acid combined with myo-inositol, with or without metformin, in women with polycystic ovary syndrome (PCOS).

A total of 180 patients will be randomized into three groups:

Myo-inositol with folic acid Myo-inositol + alpha-lipoic acid Myo-inositol + alpha-lipoic acid + metformin

The study duration is 6 months. Outcomes include menstrual regularity, ovulation rate, hormonal parameters, metabolic markers, and clinical signs of hyperandrogenism.

Inclusion Criteria:

• Women aged 21 to 40 years
• Diagnosed with polycystic ovary syndrome (PCOS) according to Rotterdam criteria
• Not currently pregnant or lactating
• No hormonal therapy within the last 3 months
• Willing and able to provide informed consent

Exclusion Criteria:

• - History of diabetes mellitus, hypertension, or thyroid disorders
• History of cardiovascular, renal, or hepatic disease
• Use of hormonal contraceptives or insulin sensitizers within the last 3 months
• Known hypersensitivity or allergy to study medications (myo-inositol, alpha-lipoic acid, or metformin)
• Non-Egyptian ethnicity