Comparative Effect of Myo-inositol With That of D-chiro-inositol on Insulin Resistance in Infertile Women With Polycystic Ovary Syndrome (PCOS). (PCOS HOMA IR)

March 3, 2026 updated by: Mst.Sumyara Khatun

Effect of Myo-inositol Compared to D-chiro-inositol on Insulin Resistance in Infertile Women With Polycystic Ovary Syndrome: A Non-inferiority Trial

This randomized controlled trial was conducted in the Department of Reproductive Endocrinology and Infertility, BSMMU.A total of 80 infertile women ofPCOS withinsulinresistanceparticipatedinthestudyandwere randomly allocated into 2 groups. One group was treated with tab. Myoinositol (MI) 750 mg thrice daily and other group with D-chiro-inositol (DCI) 500 mg once daily for 3 months. After 3 months, follow up fasting blood sugar, fasting insulin and HOMA-IR were measured

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

After obtaining approval of the Institutional Review Board (IRB), this randomized clinical trial was conducted at Bangabandhu Sheikh Mujib Medical University (BSMMU), Dhaka. Already diagnosed patients of polycystic ovary syndrome with infertilitywithHOMA-IR>2.0attendingintheOPDofReproductiveEndocrinology and Infertility Department at BSMMU were the study population. After approval of protocol, women with PCOS fulfilling inclusion and exclusion criteria were explained in detail regarding the objectives, rationality, procedure, and potential benefits of the study. The patients were counseled regarding the drugs and unexpected side-effects and an informed written consent was taken.

Those who gave voluntary informed consent were randomized to any of the two treatment arms.Afterenrollmentofthepatients, allocation was doneby computerized permuted block randomization. Allocation concealment was done using serially numbered closed opaque envelopes. Each envelope was labeled with a serial number and had a card inside notingthe intervention drug. Allocation never changed after opening the closed envelope. Eligible women were randomly allocated into two groups:

Experimental group: Myoinositol group:Tab Myoinositol (Tab Myosit, Renata Pharmaceutical Limited)750mg was given three times daily for 3 months

Controlgroup:D-chiro-inositol group: Cap D-chiro-inositol (Cap Chirocyst,Radiant Pharmaceutical Limited) 500 mg was given once daily for 3 months.

Data were collected through interviews, physical examinations and laboratory investigations. Prior to commencement of treatment, full assessment including demographic and clinical information (age, weight, height, BMI, waist circumference, hirsutism, acne, acanthosis nigricans)and the result of baseline investigations were undertaken. All the data were enrolled in the clinical record form for this study.

Follow up:

During the study period, patients were contacted every monthover telephone and inquired about the compliance to the regimen as well as any side effects.Second visit was scheduled at the end of 3rd month to assess the treatment outcome.

End points:

After the allotted study period of 3 months, fasting blood samples were collected to estimate fasting blood sugar level and fasting insulin. HOMA-IR was calculated using specific formula and comparison was made between the effect of myo-inositol and D-chiro-inositolon insulin resistance parameters in infertile women with polycystic ovary syndrome.

For each and every subject, a separate clinical record form was prepared. Data were collected from the patients on different visits on variables of interest using interview, observation, clinical examination, investigations and from the history sheet of the patients. The cumulative data were then subjected to analysis.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

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

  • Bangladesh
      • Dhaka, Bangladesh, 1000
        • Bangladesh Medical University

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:

  • Diagnosed case of PCOS according to Rotterdam criteria
  • Primary or secondary infertility
  • Insulin resistance (HOMA-IR >2)

Exclusion Criteria:

  • Age less than 18 years and more than 35 years
  • BMI less than 18.5kg/ m² and more than 30 kg/ m²
  • Endocrine disorders (Diabetes mellitus, hypothyroidism, hyperprolactinemia)
  • Any contraindications to MI or DCI
  • Any insulin sensitizer (metformin or inositol) in the last three months

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental arm: Myoinositol Group
Myo-inositol group:Tab Myo-inositol 750mg 3 times daily for 3 months
Dietary supplement: Tab Myo-inositol 750mg
Tab Myo-inositol 750mg 3 times daily for 3 months
Active Comparator: Comparator arm: D chiro-inositol group
D-chiro-inositol group: Cap D-chiro-inositol 500 mg once daily for 3 months
Dietary supplement: D-chiro-inositol 500mg
Cap D-chiro-inositol 500 mg once daily for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
• Fasting insulin
Time Frame: 12 weeks
Serum fasting insulinlevel wasdeterminedby chemiluminescent microparticle immunoassay (CMIA) usingcommertially available Alinityi reagent kit
12 weeks
HOMA-IR
Time Frame: 12 weeks

HOMA-IR was calculated by usingfollowing formula:

HOMA-IR= Fasting glucose (mmol/L) x Fasting insulin (µU/ml) divided by 22.5. HOMA-IR was 1.93 at the 75thpercentile among Indian population and 1.82 at the75th percentile among Pakistani population (Hydrie et al, 2012).

So, for the present study, HOMA-IR >2 was considered as insulin resistance
12 weeks

Collaborators and Investigators

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

Sponsor

Mst.Sumyara Khatun

Collaborators

Bangladesh Medical University

Investigators

  • Study Director: Shakeela Ishrat, FCPS, Bangladesh Medical University

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)

June 1, 2023

Primary Completion (Actual)

May 1, 2024

Study Completion (Actual)

May 1, 2024

Study Registration Dates

First Submitted

February 10, 2026

First Submitted That Met QC Criteria

March 3, 2026

First Posted (Actual)

March 6, 2026

Study Record Updates

Last Update Posted (Actual)

March 6, 2026

Last Update Submitted That Met QC Criteria

March 3, 2026

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4350 (PCORI)

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

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.

Clinical Trials on PCOS (Polycystic Ovary Syndrome)

Clinical Trials on Tab Myo-inositol 750mg

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Benin

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe