Poly Cystic Ovary Syndrome
Conditions
Keywords
PCOS Myo-Inositol Alpha Lipoic Acid Metformin Insulin Resistance Ovulation
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.
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.
Interventions
DRUGMyo-inositol
Myo-inositol administered orally at a dose of 2 g twice daily for 6 months.
DIETARY_SUPPLEMENTFolic Acid
Folic acid administered orally at a dose of 200 micrograms twice daily for 6 months.
DRUGAlpha Lipoic Acid
Alpha-lipoic acid administered orally at a dose of 600 mg once daily for 6 months.
DRUGMetfomin
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.
Sponsors
Beni-Suef University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ovulation Rate | From baseline to 6 months | Ovulation confirmed by mid-luteal serum progesterone level greater than 3 ng/mL or ultrasound-confirmed follicular rupture. |
| Menstrual Cycle Regularity | 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
| Measure | Time frame | Description |
|---|---|---|
| Serum Prolactin Levels | Baseline, 3 months, and 6 months | Change in serum prolactin levels measured in ng/mL using standard laboratory assays. |
| Body Mass Index (BMI) | Baseline, 3 months, and 6 months | Change in body mass index calculated as weight in kilograms divided by height in meters squared (kg/m²). |
| Serum Triglycerides | Baseline, 3 months, and 6 months | Change in fasting serum triglyceride levels measured in mg/dL. |
| Low-Density Lipoprotein (LDL) Cholesterol | Baseline, 3 months, and 6 months | Change in serum LDL cholesterol levels measured in mg/dL. |
| High-Density Lipoprotein (HDL) Cholesterol | Baseline, 3 months, and 6 months | Change in serum HDL cholesterol levels measured in mg/dL. |
| Fasting Blood Glucose | Baseline, 3 months, and 6 months | Change in fasting blood glucose levels measured in mg/dL after an overnight fast. |
| Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) | Baseline, 3 months, and 6 months | Change in insulin resistance calculated using the HOMA-IR index based on fasting glucose and insulin levels. |
| Testosterone | Baseline, 3 months, and 6 months | Change in serum testosterone levels measured in ng/dL. |
| Serum Luteinizing Hormone (LH) | Baseline, 3 months, and 6 months | Change in serum luteinizing hormone levels measured in mIU/mL using standard laboratory assays. |
| Serum Follicle-Stimulating Hormone (FSH) | Baseline, 3 months, and 6 months | Change in serum follicle-stimulating hormone levels measured in mIU/mL using standard laboratory assays. |
Countries
Egypt
Contacts
CONTACTAhmed A Abdelkader, Lecturer Assistant
CONTACTMarwa Mohsen Mahmoud, Lecturer
Outcome results
None listed