Levocarnitine plus myoinositol versus myoinositol alone for insulin resistance and hormone balance in women with PCOS
Official title: 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
Run by Bangladesh Medical University · NCT07266259 · Data updated 2026-11-12
This test will see whether adding levocarnitine to myoinositol improves insulin resistance and hormone levels in subfertile women with insulin-resistant PCOS.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 40 Years |
| Sex | Women only |
| Enrollment | 72 (estimated) |
| Sponsor | Bangladesh Medical University Academic / other |
| Locations | 2 sites (Dhaka, Shahbag and 1 other locations) |
| Status | Recruiting |
| Started | September 19, 2025 |
| Main results expected | August 18, 2026 |
| Study ends | March 1, 2027 |
| Registry record updated | December 19, 2025 |
| Trial ID | NCT07266259 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are subfertile women aged 18–40 with PCOS and documented insulin resistance (HOMA‑IR >2.6) who are not pregnant, do not have diabetes or hypothyroidism, and have not used insulin-sensitizing or inositol therapies in the past three months.
✕Probably not a fit
Patients with diabetes, thyroid disease, current pregnancy, known allergy to the study drugs, or PCOS without insulin resistance are unlikely to benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized controlled trial will enroll 72 subfertile women aged 18–40 with insulin-resistant PCOS (HOMA‑IR >2.6) at Bangladesh Medical University. Participants will be randomly assigned to receive levocarnitine plus myoinositol or myoinositol alone, taken twice daily for three months. Clinical measures (weight, waist/hip, hirsutism, acne) and fasting blood tests including glucose, insulin, and hormonal panels will be collected at baseline and after three months to measure changes in insulin resistance and hormone levels. Safety and adverse events related to levocarnitine and myoinositol will be recorded.
Why it matters
Potential benefit: If successful, the combination could improve insulin sensitivity and hormone balance, potentially restoring ovulation and increasing chances of pregnancy.
How similar studies have gone: Myoinositol has prior supportive evidence for improving insulin sensitivity and ovulation in PCOS, while levocarnitine has smaller, less conclusive studies, so combining them is a moderately novel approach with limited direct prior data.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
Bangladesh Medical University
Dhaka, Shahbag, Bangladesh Recruiting -
Bangladesh Medical University
Dhaka, Shahbag, Bangladesh Not yet recruiting
Study contacts
- Study coordinator: Mst.Sumyara Khatun, MS
- Email: sumirmc09@gmail.com
- Phone: +8801746046581
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.