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

De-identified individual participant data underlying the results reported in publications will be made available upon reasonable request to the principal investigator.

Data will be available beginning 6 months after publication of the study results and will be available for up to 2 years.

Access will be granted to qualified researchers upon reasonable request to the principal investigator. Requests will be reviewed based on scientific merit and ethical considerations. Data will be provided after approval and signing of a data sharing agreement.