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NCT Number: NCT07630779

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

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.

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Key information

Conditions

Poly Cystic Ovary Syndrome

Age range

21 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Faculty of Medicine, Cairo University

Cairo, Cairo Governorate, Egypt

Location status: Recruiting

Location contact

Hesham ElShaer, Professor

CONTACT

[email protected]

+0201223130881

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Myo-inositol

Drug

Myo-inositol administered orally at a dose of 2 g twice daily for 6 months.

Folic Acid

Dietary Supplement

Folic acid administered orally at a dose of 200 micrograms twice daily for 6 months.

Alpha lipoic acid

Drug

Alpha-lipoic acid administered orally at a dose of 600 mg once daily for 6 months.

Metfomin

Drug

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 outcomes

  1. Ovulation Rate

    Time frame: From baseline to 6 months

    Ovulation confirmed by mid-luteal serum progesterone level greater than 3 ng/mL or ultrasound-confirmed follicular rupture.

  2. Menstrual Cycle Regularity

    Time frame: From baseline to 6 months

    Proportion of participants achieving menstrual cycle regularity, defined as cycle length between 21 and 35 days for at least two consecutive cycles during the study period.

Secondary outcomes

  1. Serum Prolactin Levels

    Time frame: Baseline, 3 months, and 6 months

    Change in serum prolactin levels measured in ng/mL using standard laboratory assays.

  2. Body Mass Index (BMI)

    Time frame: Baseline, 3 months, and 6 months

    Change in body mass index calculated as weight in kilograms divided by height in meters squared (kg/m²).

  3. Serum Triglycerides

    Time frame: Baseline, 3 months, and 6 months

    Change in fasting serum triglyceride levels measured in mg/dL.

  4. Low-Density Lipoprotein (LDL) Cholesterol

    Time frame: Baseline, 3 months, and 6 months

    Change in serum LDL cholesterol levels measured in mg/dL.

  5. High-Density Lipoprotein (HDL) Cholesterol

    Time frame: Baseline, 3 months, and 6 months

    Change in serum HDL cholesterol levels measured in mg/dL.

  6. Fasting Blood Glucose

    Time frame: Baseline, 3 months, and 6 months

    Change in fasting blood glucose levels measured in mg/dL after an overnight fast.

  7. Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)

    Time frame: Baseline, 3 months, and 6 months

    Change in insulin resistance calculated using the HOMA-IR index based on fasting glucose and insulin levels.

  8. Testosterone

    Time frame: Baseline, 3 months, and 6 months

    Change in serum testosterone levels measured in ng/dL.

  9. Serum Luteinizing Hormone (LH)

    Time frame: Baseline, 3 months, and 6 months

    Change in serum luteinizing hormone levels measured in mIU/mL using standard laboratory assays.

  10. Serum Follicle-Stimulating Hormone (FSH)

    Time frame: Baseline, 3 months, and 6 months

    Change in serum follicle-stimulating hormone levels measured in mIU/mL using standard laboratory assays.

Study contacts

Contact information is provided by the study sponsor or research team.

Ahmed A Abdelkader, Lecturer Assistant

CONTACT

[email protected]

+201050095206

Marwa Mohsen Mahmoud, Lecturer

CONTACT

[email protected]

+201202203223

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study 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

Acronym: ALA-MYO-PCOS

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 5, 2026
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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