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

Sponsor
Benha University
Study ID
NCT07058675
Status
Completed

Conditions

  • PCOS

Eligibility Criteria

Sex
FEMALE
Age
23 Years - 47 Years
Healthy Volunteers
Not accepted

Interventions

  • Metformin Hydrochloride 500 MG — DRUG
    metformin (MET) hydrochloride 500 mg three times daily as the standard insulin sensitizer.
  • Myoinositol — DRUG
    myoinositol/d-chiro-inositol combination (MYO/DCI) in 40:1 ratiotwice daily

Study Details

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.

Key Dates

Start date
Nov 25, 2024
Status verified
Jul 2025
Primary completion
May 30, 2025
Completion
Jun 18, 2025

Study Design

Enrollment
156 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Myoinositol Group
    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
  • Active Comparator: Metformin Group
    Patients presenting manifestations suggestive of having PCOS were evaluated for enrollment in the study, and took metformin (MET) hydrochloride 500 mg

Primary Outcome Measure

Success Rate of Treatment Regimens in Restoring Menstrual Regularity and/or Achieving Pregnancy [ Time Frame: 6~7 Months ]

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