Efficacy of Alpha Lipoic Acid Combined With Myo-Inositol in Non-Diabetic PCOS Patients (ALA-MYO-PCOS)

June 2, 2026 updated by: Ahmed Abdelkader, Beni-Suef University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Egypt
    • Cairo Governorate
      • Cairo, Cairo Governorate, Egypt
        • Recruiting
        • Faculty of Medicine, Cairo University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Myo-Inositol + Folic Acid
Participants receive myo-inositol 2 g twice daily combined with folic acid 200 µg twice daily for 6 months.
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.
Experimental: Myo-Inositol + Folic Acid + Alpha-Lipoic Acid
Participants receive myo-inositol 2 g twice daily and folic acid 200 µg twice daily combined with alpha-lipoic acid 600 mg once daily for 6 months.
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.
Experimental: Myo-Inositol + Folic Acid + Alpha-Lipoic Acid + Metformin
Participants receive myo-inositol 2 g twice daily and folic acid 200 µg twice daily combined with alpha-lipoic acid 600 mg once daily and metformin titrated up to 1500 mg/day over 2 weeks for 6 months.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From baseline to 6 months
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.
From baseline to 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serum Prolactin Levels
Time Frame: Baseline, 3 months, and 6 months
Change in serum prolactin levels measured in ng/mL using standard laboratory assays.
Baseline, 3 months, and 6 months
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).
Baseline, 3 months, and 6 months
Serum Triglycerides
Time Frame: Baseline, 3 months, and 6 months
Change in fasting serum triglyceride levels measured in mg/dL.
Baseline, 3 months, and 6 months
Low-Density Lipoprotein (LDL) Cholesterol
Time Frame: Baseline, 3 months, and 6 months
Change in serum LDL cholesterol levels measured in mg/dL.
Baseline, 3 months, and 6 months
High-Density Lipoprotein (HDL) Cholesterol
Time Frame: Baseline, 3 months, and 6 months
Change in serum HDL cholesterol levels measured in mg/dL.
Baseline, 3 months, and 6 months
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.
Baseline, 3 months, and 6 months
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.
Baseline, 3 months, and 6 months
Testosterone
Time Frame: Baseline, 3 months, and 6 months
Change in serum testosterone levels measured in ng/dL.
Baseline, 3 months, and 6 months
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.
Baseline, 3 months, and 6 months
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.
Baseline, 3 months, and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beni-Suef University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 10, 2026

Primary Completion (Estimated)

September 10, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

June 2, 2026

First Submitted That Met QC Criteria

June 2, 2026

First Posted (Actual)

June 5, 2026

Study Record Updates

Last Update Posted (Actual)

June 5, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N-52-2026

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

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

IPD Sharing Access Criteria

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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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