Effect of Levocarnitine Plus Myoinositol Versus Myoinositol Alone on Hormonal and Insulin Resistance in PCOS Women
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
1 other identifier
interventional
72
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2025
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 19, 2025
CompletedFirst Submitted
Initial submission to the registry
September 21, 2025
CompletedFirst Posted
Study publicly available on registry
December 5, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 18, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
December 19, 2025
September 1, 2025
11 months
September 21, 2025
December 13, 2025
Conditions
Keywords
Outcome Measures
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
Baseline to 12 weeks after treatment
Secondary Outcomes (4)
Change in serum LH level
Baseline and after 12 weeks of treatment
Change in serum FSH level
baseline and 12 weeks after treatment
Change in LH:FSH ratio
baseline and 12 weeks after treatment
Change in serum free testosterone
baseline and 12 weeks after treatment
Study Arms (2)
Experimental arm:( Levocarnitine and myoinositol)
EXPERIMENTALParticipants will receive levocarnitine 330mg and myoinositol 750mg twice daily for 3 months
Active Comparator (Myoinositol)
ACTIVE COMPARATORParticipants will receive myoinositol 750mg twice daily for 3 months
Interventions
Myoinositol 750mg twice daily for 3 months
Levocarnitine 330 mg and Myoinositol 750 mg twice daily for 3 months
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Bangladesh Medical University
Dhaka, Shahbag, 1000, Bangladesh
Bangladesh Medical University
Dhaka, Shahbag, 1000, Bangladesh
Related Publications (2)
Genazzani AD, Battipaglia C, Foschi M, Semprini E, Aio C, Spelta E, Kostrzak A, Rusce ML, Szeliga A, Meczekalski B. Improved insulin sensitivity and reproductive profile in overweight/obese PCOS patients undergoing integrative treatment with carnitines, L-arginine, L-cysteine and myo-inositol. Gynecol Endocrinol. 2025 Dec;41(1):2458710. doi: 10.1080/09513590.2025.2458710. Epub 2025 Jan 28.
PMID: 39874141BACKGROUNDAgarwal A, Sengupta P, Durairajanayagam D. Role of L-carnitine in female infertility. Reprod Biol Endocrinol. 2018 Jan 26;16(1):5. doi: 10.1186/s12958-018-0323-4.
PMID: 29373970BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jemine Banu, MS
Bangladesh Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Medical Officer
Study Record Dates
First Submitted
September 21, 2025
First Posted
December 5, 2025
Study Start
September 19, 2025
Primary Completion (Estimated)
August 18, 2026
Study Completion (Estimated)
March 1, 2027
Last Updated
December 19, 2025
Record last verified: 2025-09