Effect of Levocarnitine Plus Myoinositol Versus Myoinositol Alone on Hormonal and Insulin Resistance in PCOS Women

December 13, 2025 updated by: Mst.Sumyara Khatun

Effects of Levocarnitine and Myoinositol in Comparison to Myoinositol Alone on Hormonal and Insulin Resistance Parameters in Subfertile Women With Insulin Resistant Polycystic Ovary Syndrome

The goal of this clinical trial is to learn if combination of levocarnitine and myoinositol works better than myoinositol alone on insulin resistance and hormonal parameters in subfertile women with insulin resistant polycystic ovary syndrome . It will also learn about the safety of drug levocarnitine and myoinositol. The main questions it aims to answer are:

Does combined action of levocarnitine and myoinositol improve insulin resistance and hormonal parameters in comparison to myoinositol alone in subfertile women with insulin resistant polycystic ovary syndrome ? What medical problems do participants have when taking drug levocarnitine and myoinositol? Researchers will compare the drug combination of levocarnitine and myoinositol to myoinositol alone to see if combination therapy works better?

Participants will:

Take drug levocarnitine and myoinositol or a myoinositol alone twice daily for 3 months Visit the clinic once after 3 months for checkups and tests Keep a diary of their symptoms and the number of times.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

After obtaining approval of the Institutional Review Board, this randomized controlled trial will be conducted in the department of Reproductive Endocrinology & Infertility,,Bangladesh Medical University (BMU), Shahbag,Dhaka. A total number of 72 subfertile women with insulin resistance polycystic ovary syndrome, after fulfilling the inclusion and exclusion criteria will be approached for informed written consent after discussing the purpose and procedure of the study. This patient will be collected from REI outdoor department of Reproductive Endocrinology & Infertility, BMU.Every patient will be asked to come fasting on a particular day, time, and place. Related history will be taken and physical examination (height, weight, waist circumference, hip circumference, acne, hirsutism, acanthosis nigricans) will be done and all data will be documented in a pretested semi-structured questionnaire.

After adequate preparation and precaution, about 04 ml of venous blood will be drawn from each participant after 8-12 hours of fasting.

About4 ml of whole blood collected during fasting, 2 ml will be kept in a fluorinated tube for measuring fasting blood glucose (FBG), and 2 ml of blood for serum collection, will be kept standing for 15 minutes to allow clotting before centrifugation. After centrifugation, the serum will be separated and kept in microcentrifuge tubes. After proper labeling, the fluorinated tube and adequate serum will be tested for fasting blood sugar andserum fasting insulin on the same collection day in department of biochemistry and molecular biology,BMU.Fasting blood glucose by glucose oxidase method,fasting insulin by chemiluminescent technology by atellicaIM IRI assay in BMU. Then HOMA-IR will be calculated.If HOMA-IR index >2.6 ,then patient will be asked to come on their second day of menstruation.After adequate preparation and precaution, about 4 ml of venous blood will be drawn from each participant,will be kept standing for 15 minutes to allow clotting before centrifugation. After centrifugation, the serum will be separated and kept in microcentrifuge tubes. After proper labeling, adequate serum will be tested for serum follicle stimulating hormone(FSH),serum luteinizing hormone(LH) by chemiluminescence immunoassay(ADVIA Centaur XPT Immunoassay) and serum free testosterone level by chemiluminescence (MAGLUMI X8) on the same collection day in microbiology & immunology department of BMU.

Detailed socio-demographic data, history,examination findings and investigations will be recorded in a predesigned data sheet.

Eligible women who will give their informed consent will be randomized into two groups. Allocation concealment will be done by serially numbered sealed envelopes. Each envelope will be labeled with a serial number and will have a card noting the intervention type. Allocation will never be changed after opening the sealed envelopes.

The experimental group will be treated with levocarnitine 330mg and myoinositol 750mg twice daily for 3 months.The comparator group will be treated with myoinositol 750 mg twice daily alone for 3 months.Then monthly over phone follow-up will be given about the patient's compliance. Any adverse events or side effects related to supplementation will be recorded and managed accordingly.

They will also be informed not to take other medications except after consulting with us.

After 3 months of intervention patients will come at Reproductive Endocrinology Infertility department on their second day(D2) of menstruation with 8-12 hours fasting. Then I will check strip of drug whether patient had taken the drug properly or not. Fasting blood sugar,fasting insulin,serum FSH,LH,free testosterone will be done by the same procedure.

Then data will be collected from the patients on using interviews, observation, clinical examination, investigations. The cumulative data will be subjected to analysis. All the clinical, biochemical and hormonal information will be documented in a pretested,semi structured clinical case record form.

Study Type

Interventional

Enrollment (Estimated)

72

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 Contact

Study Contact Backup

Study Locations

  • Bangladesh
    • Shahbag
      • Dhaka, Shahbag, Bangladesh, 1000
        • Recruiting
        • Bangladesh Medical University
        • Contact:
          • Mst Sumyara Khatun Medical officer, MS
          • Phone Number: +8801746046581
          • Email: sumirmc09@gmail.com
        • Sub-Investigator:
          • Jemine Banu, MS
        • Contact:
        • Principal Investigator:
          • Mst rebeka sultana
      • Dhaka, Shahbag, Bangladesh, 1000
        • Not yet recruiting
        • Bangladesh Medical University
        • Contact:
          • Mst sumiyara khatun

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:

  • Age:18-40 years old.
  • Diagnosed cases of PCOS patients(both old & new cases) according to International evidence-based guideline criteria 2023
  • Primary or secondary subfertility.
  • Insulin resistance (HOMA-IR >2.6)

Exclusion Criteria:

  • Hypothyroidism
  • Diabetes mellitus
  • Hormonal (Myo-inositol,D-chiro-inositol) or insulin sensitizing drugs like Metformin,Pioglitazone etc. treatment in the last three months
  • Known hypersensitivity to Myo-inositol and Levo-carnitine
  • Pregnancy

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:( Levocarnitine and myoinositol)
Participants will receive levocarnitine 330mg and myoinositol 750mg twice daily for 3 months
Combination product: Levo-Carnitine
Levocarnitine 330 mg and Myoinositol 750 mg twice daily for 3 months
Other Names:
  • Myoinositol
Active Comparator: Active Comparator (Myoinositol)
Participants will receive myoinositol 750mg twice daily for 3 months
Dietary supplement: Myoinositol
Myoinositol 750mg twice daily for 3 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in homeostatic model assessment of Insulin Resistance (HOMA-IR)
Time Frame: Baseline to 12 weeks after treatment
HOMA-IR will be calculated as (fasting insulin(micro IU/mL*fasting glucose(mmol/L)/22.5
Baseline to 12 weeks after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in serum LH level
Time Frame: Baseline and after 12 weeks of treatment
Serum LH level will be measured on day 2 of the menstrual cycle by Chemiluminescence immunoassay [ADVIA Centaur XPT ImmunoassaySystem].D2-D5 Serum LH-5-20IU/L.
Baseline and after 12 weeks of treatment
Change in serum FSH level
Time Frame: baseline and 12 weeks after treatment
Serum FSH level will be measured on day 2of the menstrual cycle by Chemiluminescence immunoassay [ADVIA Centaur XPTImmunoassay System].(D2-D5) Serum FSH-5-20IU/L
baseline and 12 weeks after treatment
Change in LH:FSH ratio
Time Frame: baseline and 12 weeks after treatment
The LH/FSH ratio will be calculated by dividing serum LH (mIU/mL) by FSH mIU/mL).
baseline and 12 weeks after treatment
Change in serum free testosterone
Time Frame: baseline and 12 weeks after treatment
Free testosterone will bemeasured on menstrual day 2 by Chemiluminescence immunoassay [MAGLUMI X8, Germany]. Normal value for a female is 0.7 to 3.6 pg/mL
baseline and 12 weeks after treatment

Collaborators and Investigators

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

Sponsor

Mst.Sumyara Khatun

Investigators

  • Study Director: Jemine Banu, MS, 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)

September 19, 2025

Primary Completion (Estimated)

August 18, 2026

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

September 21, 2025

First Submitted That Met QC Criteria

November 24, 2025

First Posted (Estimated)

December 5, 2025

Study Record Updates

Last Update Posted (Actual)

December 19, 2025

Last Update Submitted That Met QC Criteria

December 13, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5722

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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