Clomiphene citrate (CC) plus L-Carnitine improves clinical pregnancy rate along with glycemic status and lipid profile in clomiphene-resistant polycystic ovary syndrome patients: A triple-blind randomized controlled clinical trial

Abstract

Despite the high prevalence of polycystic ovary syndrome (PCOS), its pathogenesis has not been well understood. This study was designed to evaluate the reproductive and metabolic effects of L-carnitine in clomiphene citrate (CC)-resistant PCOS women. The triple-blind randomized controlled clinical trial was conducted in the infertility clinic of the Imam Hossein hospital and registered with registration number: IRCT20210415050980N1. A total of 148 CC-resistance PCOS women have randomly divided into two groups; group A received 150 mg/day CC from day 5 to day 9 of the ovulation cycle and 3 g oral L-carnitine, and Group B received 150 mg/day oral CC plus placebo. The primary outcome was the clinical pregnancy rate. The secondary outcomes were hormonal and metabolic profile changes. L-carnitine significantly improves ovulation and pregnancy rate (71.4% vs. 28.6%; p < 0.001 and 33% vs. 11%; p < 0.001). The number of stimulated follicles reaching˃17 mm diameter was significantly higher in Group A compared to Group B (2.14 ± 0.64 vs. 0.71 ± 0.7; p < 0.001). Endometrium was significantly thicker in Group A (8.14 ± 1.89 mm vs. 6.43 ± 1.3 mm; p < 0.001). L-carnitine treatment significantly decreased fasting serum glucose and Hb A1c (P > 0.001) and improved lipid profile. L-carnitine treatment may increase pregnancy rate along with improving the glycemic status and lipid profile. However, further studies are recommended to explore the exact mechanisms of L-carnitine role in patients with PCOS. • The number of stimulated follicles reaching˃17 mm diameter was significantly higher in Clomiphene citrate plus L-carnitine group compared to Clomiphene citrate plus placebo Group. • L-carnitine treatment significantly increased endometrium thickness. • L-carnitine treatment significantly decreased fasting serum glucose and Hb A1c as well as improved lipid profile. • L-carnitine significantly improve ovulation rate and pregnancy rate.