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OpenTrials
Completed

NCT Number: NCT07058675

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

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.

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Key information

Conditions

PCOS

Age range

23 year–47 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Benha university

Banhā, El Qalyoubia, 13511, Egypt

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

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

Other names: myoinositol/d-chiro-inositol combination (MYO/DCI) in 40:1 ratio

Primary outcomes

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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

Myoinositol Therapy May Adjust The Metabolic Deregulation in Infertile Polycystic Ovarian Syndrome (PCOS) Women Through Modulation of The TyG Index-BMI: A Comparative Study Versus Metformin

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 10, 2025
Registry last updated
Jul 10, 2025

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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