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

Not Applicable

Completed

• Conditions: PCOS
• Interventions: Drug: Myoinositol; Drug: Metformin Hydrochloride 500 MG

• Registration Number: NCT07058675
• Lead Sponsor: Benha University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-11-25
• Primary Completion: 2025-05-30
• Study Completion: 2025-06-18
• Status Verified: 2025-07
• Study First Submitted: 2025-07-01
• Study First Submitted QC: 2025-07-01
• Last Update Submitted: 2025-07-01
• Study First Posted: 2025-07-10
• Last Update Posted: 2025-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 156

Inclusion Criteria

• Patients presenting manifestations suggestive of having PCOS;
• Patients were free of exclusion criteria.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Myoinositol Group	Myoinositol	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
Metformin Group	Metformin Hydrochloride 500 MG	Patients presenting manifestations suggestive of having PCOS were evaluated for enrollment in the study, and took metformin (MET) hydrochloride 500 mg

Primary Outcome Measures

Name	Time	Method
Success Rate of Treatment Regimens in Restoring Menstrual Regularity and/or Achieving Pregnancy	6~7 Months	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.

Trial Locations

Locations (1)

Benha university; 🇪🇬 Banhā, El Qalyoubia, Egypt