Study of Levocarnitine Plus Myoinositol Versus Myoinositol Alone to Improve Hormone and Insulin Resistance in Women with Polycystic Ovary Syndrome

What this Trial Is About

Researchers are evaluating whether the combination of levocarnitine and myoinositol is more effective than myoinositol alone in improving insulin resistance and hormonal parameters in subfertile women with insulin resistant polycystic ovary syndrome PCOS. The study also aims to assess the safety of levocarnitine and myoinositol in this group of women. This randomized controlled trial will include 72 women diagnosed with insulin resistant PCOS and subfertility, following specific criteria and consent procedures. Participants will be randomly assigned to one of two groups one receiving levocarnitine 330 mg plus myoinositol 750 mg twice daily for 3 months, and the other receiving myoinositol 750 mg twice daily alone for the same duration. They will be monitored monthly by phone to check compliance and any side effects. After 3 months of treatment, participants will return for clinical and laboratory assessments on the second day of menstruation after fasting. During the study, participants will undergo detailed history taking, physical exams, and blood tests measuring fasting blood glucose, fasting insulin, and hormones including FSH, LH, and free testosterone. Insulin resistance will be evaluated using the HOMA-IR index. Researchers will collect data on symptoms and treatment adherence through diaries and interviews. The main outcome is the change in insulin resistance after 12 weeks, with additional hormonal changes also measured. Safety and side effects will be recorded throughout the study.

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