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Completed

NCT Number: NCT04892186

Effects of Myo-inositol in Women With Polycystic Ovary Syndrome

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.

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Key information

Conditions

Polycystic Ovary Syndrome Adnexal Diseases Cysts Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Glucose Intolerance Glucose Metabolism Disorders Gonadal Disorders Hyperglycemia Hyperinsulinism Insulin Resistance Metabolic Diseases Neoplasms Nutritional and Metabolic Diseases Ovarian Cysts Ovarian Diseases Resistance, Insulin Urogenital Diseases

Age range

19 year–36 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Das Clinicas - Fmusp, São Paulo, Brazil

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Myo-inositol

Drug

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

Drug

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.

Primary outcomes

  1. Menstrual cycle

    Time frame: 6 months

    Analysis of period calendar.

  2. Change in glucose metabolism

    Time frame: Every 3 months for up to 6 months

    Glucose tolerance curve with insulin curve will be performed every 3 months.

  3. Change in glycated hemoglobin

    Time frame: Every 3 months for up to 6 months

    Glycated hemoglobin will be performed every 3 months.

  4. Change in ultrasound of the ovaries

    Time frame: 6 months

    Transvaginal ultrasound to assess ovarian volume (measured in cubic centimeters) will be done before and after treatment.

  5. Change in antral follicle count

    Time frame: 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)

  6. Change in body mass index

    Time frame: Every 3 months for up to 6 months

    Body mass index (kg/m2) will be assessed every 3 months.

  7. Change in Abdominal Circumference and Hip Circumference

    Time frame: Every 3 months for up to 6 months

    Abdominal circumference and hip circumference (measured in centimeters) will be assessed every 3 months.

  8. Change in body weight in kilograms

    Time frame: Every 3 months for up to 6 months

    Patients will be weighed every 3 months (measured in kilograms).

Secondary outcomes

  1. Assess adherence to treatment.

    Time frame: 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).

  2. Side effects

    Time frame: 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.

  3. Hepatic steatosis

    Time frame: 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).

  4. Liver enzymes

    Time frame: 6 months

    Liver enzymes (aspartate aminotransferase, alanine aminotransferase,alkaline phosphatase) will be collected before and after treatment

  5. Chronic inflammatory process

    Time frame: 6 months

    Chronic inflammatory markers will be accessed by analyzing RNA messenger from cervical-vaginal cytology before and after treatment.

  6. C-reactive protein

    Time frame: 6 months

    Chronic inflammatory process will be also evaluated by serum measurement of c-reactive protein before and after treatment.

  7. Homocysteine

    Time frame: 6 months

    Serum homocysteine dosage will be done before and after treatment to help assess a chronic inflammatory process.

  8. Change in Lipid Profile

    Time frame: 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

  9. Modified Ferriman-Gallwey Score

    Time frame: 6 months

    Modified Ferriman-Gallwey Score will be performed before and after treatment and patients with a score above 7 will be considered hirsute.

  10. Hormonal dosage (FSH, LH, progesterone, estradiol)

    Time frame: 6 months

    Hormonal dosage (FSH - Follicle-stimulating hormone, LH - luteinizing hormone, progesterone, estradiol) will be preformed before and after treatment.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
May 19, 2021
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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