Myoinositol vs. Metformin for Polycystic Ovarian Syndrome (PCOS): Impact on Metabolic Health and Fertility

NCT07058675 | Completed

• 1 other identifier: RC 1-11-2024
• Study Type: interventional
• Target: 156
• Locations: 1 country
• Sites: 1

Brief Summary

The study aimed to assess how a 6-month insulin sensitizer therapy impacts insulin resistance, glucose tolerance, and hormonal levels in women with PCOS. Researchers evaluated 156 PCOS patients, measuring their BMI, HOMA-IR (for insulin resistance), TyG index, TyG index-BMI, and total testosterone. Participants were divided into two groups, receiving either metformin or a myoinositol/d-chiro-inositol combination for six months, after which all parameters were re-evaluated to determine the percentage of change.

Conditions

PCOS

Outcome Measures

Primary Outcomes (1)

• Success Rate of Treatment Regimens in Restoring Menstrual Regularity and/or Achieving Pregnancy

  The proportion of patients who regained a regular menstrual pattern and/or achieved pregnancy during the study, reflecting the effectiveness of the administered treatment regimens.

  6~7 Months

Study Arms (2)

Myoinositol Group

ACTIVE COMPARATOR

Patients presenting manifestations suggestive of having PCOS were evaluated for enrollment in the study, and took the tablets containing myoinositol/d-chiro-inositol combination (MYO/DCI) in 40:1 ratio

Drug: Myoinositol

Metformin Group

ACTIVE COMPARATOR

Patients presenting manifestations suggestive of having PCOS were evaluated for enrollment in the study, and took metformin (MET) hydrochloride 500 mg

Drug: Metformin Hydrochloride 500 MG

Interventions

Metformin Hydrochloride 500 MG DRUG

metformin (MET) hydrochloride 500 mg three times daily as the standard insulin sensitizer.

Metformin Group

Myoinositol DRUG

myoinositol/d-chiro-inositol combination (MYO/DCI) in 40:1 ratiotwice daily

Also known as: myoinositol/d-chiro-inositol combination (MYO/DCI) in 40:1 ratio

Myoinositol Group

Eligibility Criteria

• Age: 23 Years - 47 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients presenting manifestations suggestive of having PCOS;

You may not qualify if:

• Patients who were maintained on a diet regimen, or/and regular exercise;
• Patients who were on medical therapy of PCOS, antidiabetic or/and antihypertensive therapy;
• Patients who underwent laparoscopic drilling;
• Patients with dyslipidemia, hereditary lipoprotein disorders:
• Patients with chronic liver or kidney diseases.

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha university

Banhā, El Qalyoubia, 13511, Egypt

Location

MeSH Terms

Interventions

Metformin; Inositol

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals; Sugar Alcohols; Alcohols; Carbohydrates

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Obstetrics & Gynecology, Faculty of Medicine, Benha University

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: July 10, 2025
• Study Start: November 25, 2024
• Primary Completion: May 30, 2025
• Study Completion: June 18, 2025
• Last Updated: July 10, 2025

Record last verified: 2025-07

Locations

EG (1)