Effects of Myo-inositol in Women With Polycystic Ovary Syndrome
- Conditions
- Resistance, InsulinGlucose IntolerancePolycystic Ovary Syndrome
- Interventions
- Registration Number
- NCT04892186
- Lead Sponsor
- University of Sao Paulo General Hospital
- Brief Summary
The study will be carried out at the hospital of the medical school of sao paulo (HC-FMUSP) and the goal is to compare the effects of the administration of myo-inositol in relation to the effects of metformin in women with Polycystic Ovary Syndrome and insulin resistance or glucose intolerance. Menstrual cycle, hyperandrogenism, chronic inflammatory process, carbohydrate metabolism, hepatic steatosis will be evaluated. In total, 60 women in the reproductive period, with a variable age between 18 and 36 years old will be recruited and randomized in two groups: intervention- myo-inositol for 6 months, control group will use metformin also for 6 months.
- Detailed Description
The study will involve 60 women in the reproductive period, with a variable between 19 and 36 years old and diagnosed with polycystic ovary syndrome (PCOS), according to Rotterdam- European Society of Human Reproduction and Embryology (ESHRE) / American Society for Reproductive Medicine (ASRM) criteria defined in 2003 and revised in 2018, and insulin resistance (presence acanthosis nigricans) or glucose intolerance (fasting glycemia, glycated hemoglobin or 75g glycemic overload and blood glucose assessment after 2 hours). It is a comparative and non-inferiority study of myo-inositol in relation to metformin. They will be divided into two groups of 30 patients: Group I (control) - they will receive metformin 850 mg, orally, twice a day; Group II (experiment) - they will receive myo-inositol 2g + folic acid 200mcg, orally, twice a day.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 60
- Women aged 19 to 36 with diagnosis of PCOS and insulin resistance or glucose intolerance.
- Previous use of any hormonal treatment in the past three months;
- Other causes of anovulation;
- Gynecological or other associated conditions (endometriosis, adenomyosis or diabetes mellitus);
- FSH (Follicle Stimulating Hormone) > 15 Ul / L (2nd to 5th day of the cycle);
- Beta-hcG (human chorionic gonadotropin) positive (pregnancy).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Metformin Metformin 30 women with resistance insulin or glucose intolerance will receive metformin 850 mg, orally, twice a day for 6 months Myo-inositol Myo-inositol 30 women with resistance insulin or glucose intolerance will receive myo-inositol 2g + folic acid 200mcg, orally, twice a day for 6 months.
- Primary Outcome Measures
Name Time Method Menstrual cycle 6 months Analysis of period calendar.
Change in Abdominal Circumference and Hip Circumference Every 3 months for up to 6 months Abdominal circumference and hip circumference (measured in centimeters) will be assessed every 3 months.
Change in body mass index Every 3 months for up to 6 months Body mass index (kg/m2) will be assessed every 3 months.
Change in glycated hemoglobin Every 3 months for up to 6 months Glycated hemoglobin will be performed every 3 months.
Change in antral follicle count 6 months Ultrasound of the ovaries will be done before and after treatment for antral follicle count (all follicles from 2 to 9 mm will be measured)
Change in glucose metabolism Every 3 months for up to 6 months Glucose tolerance curve with insulin curve will be performed every 3 months.
Change in ultrasound of the ovaries 6 months Transvaginal ultrasound to assess ovarian volume (measured in cubic centimeters) will be done before and after treatment.
Change in body weight in kilograms Every 3 months for up to 6 months Patients will be weighed every 3 months (measured in kilograms).
- Secondary Outcome Measures
Name Time Method Hormonal dosage (FSH, LH, progesterone, estradiol) 6 months Hormonal dosage (FSH - Follicle-stimulating hormone, LH - luteinizing hormone, progesterone, estradiol) will be preformed before and after treatment.
Homocysteine 6 months Serum homocysteine dosage will be done before and after treatment to help assess a chronic inflammatory process.
Change in Lipid Profile Every 3 months for up to 6 months Serum dosage of the lipid profile (high density lipoprotein - HDL, low density lipoprotein - LDL , very low density lipoprotein - VLDL, triglycerides, total cholesterol) will be done every 3 months
Hepatic steatosis 6 months Initial liver ultrasound will be done and repeated after 6 months of treatment to assess the presence or absence of hepatic steatosis and classify it as mild (grade 1), moderate (grade 2) and severe (grade 3).
Chronic inflammatory process 6 months Chronic inflammatory markers will be accessed by analyzing RNA messenger from cervical-vaginal cytology before and after treatment.
Modified Ferriman-Gallwey Score 6 months Modified Ferriman-Gallwey Score will be performed before and after treatment and patients with a score above 7 will be considered hirsute.
Assess adherence to treatment. Every 3 months for up to 6 months Medication use diary will be delivered and will be reviewed every 3 months to assess adherence to treatment (good adherence will be considered use of more than 80% of the medication provided).
Side effects Every 3 months for up to 6 months Questionnaire will be carried out every 3 months for patient to describe the 3 main side effects and how much they have hindered the treatment or not.
Liver enzymes 6 months Liver enzymes (aspartate aminotransferase, alanine aminotransferase,alkaline phosphatase) will be collected before and after treatment
C-reactive protein 6 months Chronic inflammatory process will be also evaluated by serum measurement of c-reactive protein before and after treatment.
Trial Locations
- Locations (2)
Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
🇧🇷Sao Paulo, Brazil
Hospital Das Clinicas - Fmusp
🇧🇷Sao Paulo, Brazil