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

ConditionPolycystic Ovary Syndrome (PCOS)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorMst.Sumyara Khatun

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Myoinositol

    Dietary supplement

    Myoinositol 750mg twice daily for 3 months

  • Levo-Carnitine

    Combination product

    Levocarnitine 330 mg and Myoinositol 750 mg twice daily for 3 months

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: Experimental arm:( Levocarnitine and myoinositol)Experimental treatment 1 intervention
Group B: Active Comparator (Myoinositol)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in homeostatic model assessment of Insulin Resistance (HOMA-IR)

HOMA-IR will be calculated as (fasting insulin(micro IU/mL\*fasting glucose(mmol/L)/22.5

Time frame
Baseline to 12 weeks after treatment

Secondary outcomes

1

Change in serum LH level

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.

Time frame
Baseline and after 12 weeks of treatment
2

Change in serum FSH level

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

Time frame
baseline and 12 weeks after treatment
3

Change in LH:FSH ratio

The LH/FSH ratio will be calculated by dividing serum LH (mIU/mL) by FSH mIU/mL).

Time frame
baseline and 12 weeks after treatment
4

Change in serum free testosterone

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

Time frame
baseline and 12 weeks after treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mst.Sumyara Khatun

Lead sponsor

Bangladesh Medical University

Sponsor institution

Source ClinicalTrials.gov
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