A Phase 3 interventional study of Myo-inositol and Folic Acid in Poly Cystic Ovary Syndrome, sponsored by Beni-Suef University. Recruiting at 1 site in Egypt. Open to female participants aged 21 Years to 40 Years. Per ClinicalTrials.gov, last updated 2026-06-05.
Sponsored by Beni-Suef University · Phase 3, Interventional, and Treatment
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.
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.
Beni-Suef University is the lead sponsor of 333 studies on the registry; 116 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants receive myo-inositol 2 g twice daily combined with folic acid 200 µg twice daily for 6 months.
Drug: Myo-inositol · Dietary Supplement: Folic 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 · Dietary Supplement: Folic Acid · Drug: 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 and metformin titrated up to 1500 mg/day over 2 weeks for 6 months.
Drug: Myo-inositol · Dietary Supplement: Folic Acid · Drug: Alpha Lipoic Acid · Drug: Metfomin
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.
Ovulation Rate
Ovulation confirmed by mid-luteal serum progesterone level greater than 3 ng/mL or ultrasound-confirmed follicular rupture.
Time frame: 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.
Time frame: From baseline to 6 months
Serum Prolactin Levels
Change in serum prolactin levels measured in ng/mL using standard laboratory assays.
Time frame: Baseline, 3 months, and 6 months
Body Mass Index (BMI)
Change in body mass index calculated as weight in kilograms divided by height in meters squared (kg/m²).
Time frame: Baseline, 3 months, and 6 months
Serum Triglycerides
Change in fasting serum triglyceride levels measured in mg/dL.
Time frame: Baseline, 3 months, and 6 months
Low-Density Lipoprotein (LDL) Cholesterol
Change in serum LDL cholesterol levels measured in mg/dL.
Time frame: Baseline, 3 months, and 6 months
High-Density Lipoprotein (HDL) Cholesterol
Change in serum HDL cholesterol levels measured in mg/dL.
Time frame: Baseline, 3 months, and 6 months
Fasting Blood Glucose
Change in fasting blood glucose levels measured in mg/dL after an overnight fast.
Time frame: Baseline, 3 months, and 6 months
Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)
Change in insulin resistance calculated using the HOMA-IR index based on fasting glucose and insulin levels.
Time frame: Baseline, 3 months, and 6 months
Testosterone
Change in serum testosterone levels measured in ng/dL.
Time frame: Baseline, 3 months, and 6 months
Serum Luteinizing Hormone (LH)
Change in serum luteinizing hormone levels measured in mIU/mL using standard laboratory assays.
Time frame: Baseline, 3 months, and 6 months
Serum Follicle-Stimulating Hormone (FSH)
Change in serum follicle-stimulating hormone levels measured in mIU/mL using standard laboratory assays.
Time frame: Baseline, 3 months, and 6 months
Plan to share: Yes — De-identified individual participant data underlying the results reported in publications will be made available upon reasonable request to the principal investigator.
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Beni-Suef University