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Recruiting NCT07630779

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

Phase III Interventional Poly Cystic Ovary Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Myo-inositol, Folic Acid, Alpha Lipoic Acid, Metfomin.
Who it may be relevant to
Registry conditions: Poly Cystic Ovary Syndrome. Basic parameters: 21 years — 40 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Drug Myo-inositol
    Myo-inositol administered orally at a dose of 2 g twice daily for 6 months.
  • Dietary supplement Folic Acid
    Folic acid administered orally at a dose of 200 micrograms twice daily for 6 months.
  • Drug Alpha Lipoic Acid
    Alpha-lipoic acid administered orally at a dose of 600 mg once daily for 6 months.
  • Drug Metfomin
    Metformin administered orally starting at 500 mg once daily and titrated over two weeks to a maximum dose of 1500 mg/day (500 mg three times daily), taken after meals for 6 months.

Primary outcome measures

  • Ovulation Rate [Time frame: From baseline to 6 months]
  • Menstrual Cycle Regularity [Time frame: From baseline to 6 months]
Secondary outcome measures (10)
  • Serum Prolactin Levels [Time frame: Baseline, 3 months, and 6 months]
  • Body Mass Index (BMI) [Time frame: Baseline, 3 months, and 6 months]
  • Serum Triglycerides [Time frame: Baseline, 3 months, and 6 months]
  • Low-Density Lipoprotein (LDL) Cholesterol [Time frame: Baseline, 3 months, and 6 months]
  • High-Density Lipoprotein (HDL) Cholesterol [Time frame: Baseline, 3 months, and 6 months]
  • Fasting Blood Glucose [Time frame: Baseline, 3 months, and 6 months]
  • Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) [Time frame: Baseline, 3 months, and 6 months]
  • Testosterone [Time frame: Baseline, 3 months, and 6 months]
  • Serum Luteinizing Hormone (LH) [Time frame: Baseline, 3 months, and 6 months]
  • Serum Follicle-Stimulating Hormone (FSH) [Time frame: Baseline, 3 months, and 6 months]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Faculty of Medicine, Cairo University — Cairo

Identifiers

NCT: NCT07630779 · N-52-2026

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗