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

NCT ID: NCT07058675

Last Updated: 2025-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

156 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-25

Study Completion Date

2025-06-18

Brief Summary

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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

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Conditions

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PCOS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Myoinositol

Intervention Type DRUG

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

Metformin Group

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

Group Type ACTIVE_COMPARATOR

Metformin Hydrochloride 500 MG

Intervention Type DRUG

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

Interventions

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Metformin Hydrochloride 500 MG

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

Intervention Type DRUG

Myoinositol

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

Intervention Type DRUG

Other Intervention Names

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

Eligibility Criteria

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Inclusion Criteria

* Patients presenting manifestations suggestive of having PCOS;

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.
Minimum Eligible Age

23 Years

Maximum Eligible Age

47 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Benha University

OTHER

Sponsor Role lead

Responsible Party

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Basma Sakr

Assistant Professor of Obstetrics & Gynecology, Faculty of Medicine, Benha University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Benha university

Banhā, El Qalyoubia, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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RC 1-11-2024

Identifier Type: -

Identifier Source: org_study_id

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