Alpha-lipoic acid and myo-inositol for non-diabetic PCOS in women
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
Run by Beni-Suef University · NCT07630779 · Data updated 2026-11-12
This trial tests whether adding alpha-lipoic acid to myo-inositol (with or without metformin) helps non-diabetic women with PCOS improve menstrual regularity and ovulation.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 21 Years to 40 Years |
| Sex | Women only |
| Enrollment | 180 (estimated) |
| Sponsor | Beni-Suef University Academic / other |
| Locations | 1 site (Cairo, Cairo Governorate) |
| Status | Recruiting |
| Started | March 10, 2026 |
| Main results expected | September 10, 2026 |
| Study ends | December 2026 |
| Registry record updated | June 5, 2026 |
| Trial ID | NCT07630779 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Women aged 21-40 with PCOS (Rotterdam criteria), not pregnant or lactating, not on hormonal therapy in the last 3 months, willing to consent.
✕Probably not a fit
Individuals with diabetes or significant comorbidities, or those already taking insulin sensitizers or hormonal therapies within the last 3 months, may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In this Phase 3, randomized, parallel-group study, 180 women with PCOS will be assigned to one of three treatment regimens for six months: myo-inositol alone with folic acid, myo-inositol plus alpha-lipoic acid, or myo-inositol plus alpha-lipoic acid plus metformin. Researchers will evaluate menstrual regularity, ovulation rate, and changes in hormonal and metabolic markers, along with clinical signs of hyperandrogenism. The study aims to determine whether the combination therapies offer added benefits over myo-inositol alone. Outcomes will inform whether these regimens can improve reproductive and metabolic aspects of PCOS.
Why it matters
Potential benefit: If successful, the approach could offer a new treatment option to improve menstrual regularity and ovulation in non-diabetic women with PCOS.
How similar studies have gone: Prior studies in PCOS have shown potential benefits with myo-inositol and insulin sensitizers; this trial tests a novel combination including alpha-lipoic acid.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Faculty of Medicine, Cairo University
Cairo, Cairo Governorate, Egypt Recruiting
Study contacts
- Study coordinator: Ahmed A Abdelkader, Lecturer Assistant
- Email: ahmed.abdelkader@hu.edu.eg
- Phone: +201050095206
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.