Efficacy of Alpha Lipoic Acid Combined With Myo-Inositol in Non-Diabetic PCOS Patients
ALA-MYO-PCOS
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
1 other identifier
interventional
180
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2026
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 10, 2026
CompletedFirst Submitted
Initial submission to the registry
June 2, 2026
CompletedFirst Posted
Study publicly available on registry
June 5, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 10, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
June 5, 2026
June 1, 2026
6 months
June 2, 2026
June 2, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Ovulation Rate
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
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 Outcomes (10)
Serum Prolactin Levels
Baseline, 3 months, and 6 months
Body Mass Index (BMI)
Baseline, 3 months, and 6 months
Serum Triglycerides
Baseline, 3 months, and 6 months
Low-Density Lipoprotein (LDL) Cholesterol
Baseline, 3 months, and 6 months
High-Density Lipoprotein (HDL) Cholesterol
Baseline, 3 months, and 6 months
- +5 more secondary outcomes
Study Arms (3)
Myo-Inositol + Folic Acid
EXPERIMENTALParticipants receive myo-inositol 2 g twice daily combined with folic acid 200 µg twice daily for 6 months.
Myo-Inositol + Folic Acid + Alpha-Lipoic Acid
EXPERIMENTALParticipants 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.
Myo-Inositol + Folic Acid + Alpha-Lipoic Acid + Metformin
EXPERIMENTALParticipants 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.
Interventions
Myo-inositol administered orally at a dose of 2 g twice daily for 6 months.
Folic acid administered orally at a dose of 200 micrograms twice daily for 6 months.
Alpha-lipoic acid administered orally at a dose of 600 mg once daily for 6 months.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- \- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Medicine, Cairo University
Cairo, Cairo Governorate, Egypt
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Lecturer Assistant
Study Record Dates
First Submitted
June 2, 2026
First Posted
June 5, 2026
Study Start
March 10, 2026
Primary Completion (Estimated)
September 10, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
June 5, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data will be available beginning 6 months after publication of the study results and will be available for up to 2 years.
- 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.
De-identified individual participant data underlying the results reported in publications will be made available upon reasonable request to the principal investigator.