Levocarnitine plus myoinositol versus myoinositol alone for insulin resistance and hormone balance in women with PCOS
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
NA · Bangladesh Medical University · NCT07266259
This test will see whether adding levocarnitine to myoinositol improves insulin resistance and hormone levels in subfertile women with insulin-resistant PCOS.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 72 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Bangladesh Medical University (other) |
| Locations | 2 sites (Dhaka, Shahbag and 1 other locations) |
| Trial ID | NCT07266259 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Dhaka, Shahbag and 1 other locations
- Bangladesh Medical University — Dhaka, Shahbag, Bangladesh (NOT_YET_RECRUITING)
- Bangladesh Medical University — Dhaka, Shahbag, Bangladesh (RECRUITING)
Study contacts
- Study coordinator: Mst.Sumyara Khatun, MS
- Email: sumirmc09@gmail.com
- Phone: +8801746046581
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Polycystic Ovary Syndrome, levocarnitine myoinositol, insulin resistance hormonal parameters, polycystic ovary syndrome