Insulin resistance has important implications in the pathogenesis of the polycystic ovary syndrome (PCOS) and insulin-sensitizing drugs are considered a useful therapeutic approach. Reduction of insulin levels with administration of insulin sensitizing agents has been found to be beneficial in lowering both hyperinsulinemia, hyperandrogenemia, and restoring ovulation. Metformin alone or in combination with oral contraceptives (OCs) has been widely used in the long term treatment of women with PCOS in whom it modifies the ovarian morphology, improves intraovarian androgen levels, and enhances systemic and local insulin resistance. Despite to these beneficial effects, several side effects have been reported due to the long term administration of this drug. In the recent years, inositol has found more and more space in the reproductive clinical practice. Indeed, inositol have been classified as "insulin sensitizing agent" and it is mainly used as a chronic treatment for PCOS. Inositol exists in 9 different isomers and in particular several studies on Myo-inositol and D-chiro-inositol were reported. In this study myo-inositol versus D-chiro-inositol treatments were compared to placebo in women with PCOS and with or without insulin resistance.
Study Type
INTERVENTIONAL
Myo-inositol (2g) Folic acid (200mcg) (2 per day)
Myo-inositol (2g) Folic acid (200mcg) (2 per day)
D-Chiro-inositol (500 mg), manganese (1 mg), folic acid (200 mcg), vit B12 (1.25 mcg) (2 per day)
D-chiro-inositol (500 mg), manganese (1 mg), folic acid (200 mcg), vit B12 (1.25 mcg) (2 per day)
Folic acid (200 mcg), vit B12 (1.25 mcg) (2 per day)
Folic acid (200 mcg), vit B12 (1.25 mcg) (2 per day)
Istituto di Patologia Ostetrica e Ginecologica
Catania, Italy
Body Mass Index (BMI)
Menstrual cycle
Score acne (acne grading system by Cremoncini et al)
Score hirsutism (Ferriman-Gallwey score)
Alopecia
Oral Glucose Tolerance Test (OGTT)
Glucagon levels
C-peptide test
Myo-inositol serum concentration
D-chiro-inositol serum concentration
Luteinizing Hormone (LH), Follicle Stimulating Hormone (FSH), and Estradiol (E2) levels test
Prolactin (PRL) levels test
Thyroid-stimulating hormone (TSH), free thyroid hormone (fT3 and fT4), and alpha-1 antitrypsin (AAT) test
Total and free testosterone levels
Sex hormone binding globulin (SHBG) test
17-Hydroxyprogesterone (17-OHP) levels
Dehydroepiandrosterone (DHEA) and DHEA-sulfate (DHEAS) levels
delta 4-androstenedione levels
progesterone levels
Adrenocorticotropic Hormone (ACTH) stimulation test
Ovarian size and morphology
Ovarian ultrasound scan for the assessment of size and morphology
Antral follicle counts
Stromal/Cortical ratio in the ovary
Endometrial thickness
Transvaginal ultrasound measurement of endometrial thickness performed between day 3 and 5 of the menstrual cycle.
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