Effects of Myo-inositol in Women With Polycystic Ovary Syndrome

Polycystic Ovary Syndrome Clinical Trial

Official title:

Effects of Myo-inositol on the Menstrual Cycle, Hyperandrogenism, Chronic Inflammatory Process and Carbohydrate Metabolism in Women With Polycystic Ovary Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04892186
• Other study ID #: CAAE: 23458719.6.0000.0068
• Status: Completed
• Phase: N/A
• Start date: March 26, 2021
• Est. completion date: October 20, 2023

Study information

• Verified date: October 2023
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 20, 2023
• Est. primary completion date: October 20, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 36 Years

Eligibility

Inclusion Criteria:

• Women aged 19 to 36 with diagnosis of PCOS and insulin resistance or glucose intolerance.

Exclusion Criteria:

• 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).

Related Conditions & MeSH terms

• Glucose Intolerance
• Insulin Resistance
• Polycystic Ovary Syndrome
• Resistance, Insulin
• Syndrome

Intervention

Drug:
• Myo-inositol
30 women with polycystic ovary syndrome and insulin resistance or glucose intolerance will used myo-inositol 2g + folic acid 200mcg twice daily for 6 months, having a re-evaluation every 3 months. Evaluation will be made by transvaginal ultrasound, abdominal ultrasound, inflammatory tests, hormonal tests, glycemic curve with insulin curve, lipid profile, body mass index, evaluation of abdominal and hip circumference.
• Metformin
30 women with polycystic ovary syndrome and insulin resistance or glucose intolerance will used metformin 850 mg twice a day for 6 months, having a re-evaluation every 3 months. Evaluation will be made by transvaginal ultrasound, abdominal ultrasound, inflammatory tests, hormonal tests, glycemic curve with insulin curve, lipid profile, body mass index, evaluation of abdominal and hip circumference.

Locations

Country	Name	City	State
Brazil	Hospital Das Clinicas - Fmusp	Sao Paulo
Brazil	Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Menstrual cycle	Analysis of period calendar.	6 months
Primary	Change in glucose metabolism	Glucose tolerance curve with insulin curve will be performed every 3 months.	Every 3 months for up to 6 months
Primary	Change in glycated hemoglobin	Glycated hemoglobin will be performed every 3 months.	Every 3 months for up to 6 months
Primary	Change in ultrasound of the ovaries	Transvaginal ultrasound to assess ovarian volume (measured in cubic centimeters) will be done before and after treatment.	6 months
Primary	Change in antral follicle count	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)	6 months
Primary	Change in body mass index	Body mass index (kg/m2) will be assessed every 3 months.	Every 3 months for up to 6 months
Primary	Change in Abdominal Circumference and Hip Circumference	Abdominal circumference and hip circumference (measured in centimeters) will be assessed every 3 months.	Every 3 months for up to 6 months
Primary	Change in body weight in kilograms	Patients will be weighed every 3 months (measured in kilograms).	Every 3 months for up to 6 months
Secondary	Assess adherence to treatment.	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).	Every 3 months for up to 6 months
Secondary	Side effects	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.	Every 3 months for up to 6 months
Secondary	Hepatic steatosis	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).	6 months
Secondary	Liver enzymes	Liver enzymes (aspartate aminotransferase, alanine aminotransferase,alkaline phosphatase) will be collected before and after treatment	6 months
Secondary	Chronic inflammatory process	Chronic inflammatory markers will be accessed by analyzing RNA messenger from cervical-vaginal cytology before and after treatment.	6 months
Secondary	C-reactive protein	Chronic inflammatory process will be also evaluated by serum measurement of c-reactive protein before and after treatment.	6 months
Secondary	Homocysteine	Serum homocysteine dosage will be done before and after treatment to help assess a chronic inflammatory process.	6 months
Secondary	Change in Lipid Profile	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	Every 3 months for up to 6 months
Secondary	Modified Ferriman-Gallwey Score	Modified Ferriman-Gallwey Score will be performed before and after treatment and patients with a score above 7 will be considered hirsute.	6 months
Secondary	Hormonal dosage (FSH, LH, progesterone, estradiol)	Hormonal dosage (FSH - Follicle-stimulating hormone, LH - luteinizing hormone, progesterone, estradiol) will be preformed before and after treatment.	6 months