Impact of Myo-Inositol Alone vs Myo-Inositol Plus Metformin on Conception, Adherence, and Tolerability in PCOS

December 22, 2025 updated by: Maria Amin, PAEC general hospital

Impact of Myo-Inositol vs Combined Myo-Inositol and Metformin Therapy on Conception Rates, Treatment Adherence, and Tolerability in Overweight Women Diagnosed With PCOS: A Randomized Controlled Study

The goal of this clinical trial (prospective randomized controlled trial) is to compare whether myo-inositol alone or in combination with metformin can improve conception rates, treatment compliance, and side-effect profiles in overweight women (BMI ≥25 kg/m²) diagnosed with polycystic ovary syndrome (PCOS).

The main questions it aims to answer are:

  1. Does myo-inositol alone achieve conception rates comparable to the combination of myo-inositol and metformin?
  2. Does the combination therapy result in more side effects and lower compliance compared to myo-inositol alone? If there is a comparison group: Researchers will compare Group A (myo-inositol 4 g/day) with Group B (myo-inositol 4 g/day + metformin 1500 mg/day) to see if the addition of metformin improves conception outcomes but at the cost of tolerability.

Participants will:

  • Be randomly assigned to receive either myo-inositol alone or myo-inositol plus metformin for six months.
  • Attend follow-up visits for monitoring of pregnancy outcomes confirmed by ultrasound.
  • Report any side effects experienced during treatment.
  • Provide information on treatment adherence and dropout rates.
  • Be assessed for menstrual regularity and ovulation rates.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Isb
      • Islamabad, Isb, Pakistan, 440000
        • PAEC general hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Women aged 20 to 35 years
  • BMI ≥25 kg/m²
  • Fulfilled at least two of the three Rotterdam criteria for PCOS
  • Attempting to conceive naturally
  • No use of hormonal drugs or insulin-sensitizers in the past three months

Exclusion Criteria:

  • Endocrine disorders (e.g., diabetes, thyroid dysfunction)
  • Hepatic impairment
  • Kidney disease
  • Gastrointestinal or malabsorption issues (IBS, IBD, celiac disease)
  • Known allergies to metformin or inositol
  • Pregnant or breastfeeding

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: arm 1
in the comparison group of study: Researchers will compare Group A (myo-inositol 4 g/day)
Drug: Myoinositol
myo-inositol (4 g/day)
Experimental: arm 2
group B will be a combination group (Metformin 1500mg per day and Myo inositol 4gram per day)
Drug: Myoinositol
myo-inositol (4 g/day)
Drug: Metformin 1500 mg daily
metfromin plus myoinositol 1500mg and 4gram per day respectively

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Confirmed Clinical Pregnancy by Ultrasound
Time Frame: Up to 6 months or until pregnancy is confirmed
Clinical pregnancy defined as the presence of a gestational sac confirmed by ultrasound.
Up to 6 months or until pregnancy is confirmed

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

PAEC general hospital

Investigators

  • Principal Investigator: Maria Amin, PAEC general hospital, H-11/4, islamabad

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Actual)

July 30, 2025

Study Completion (Actual)

October 25, 2025

Study Registration Dates

First Submitted

November 14, 2025

First Submitted That Met QC Criteria

December 22, 2025

First Posted (Actual)

January 7, 2026

Study Record Updates

Last Update Posted (Actual)

January 7, 2026

Last Update Submitted That Met QC Criteria

December 22, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PGHI-IRB(DME)-RCD-06-097

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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