l-Carnitine plus metformin in clomiphene-resistant obese PCOS women, reproductive and metabolic effects: a randomized clinical trial

Abstract

To evaluate the reproductive and metabolic effects of L-carnitine plus metformin in clomiphene citrate (CC) resistant obese polycystic ovary syndrome (PCOS) women. A double-blinded randomized controlled clinical trial, clomiphene-citrate resistant obese women were allocated randomly to receive CC plus metformin and L-carnitine (n = 138) or CC plus metformin and placebo (n = 136). The primary outcome was clinical pregnancy rate. The secondary outcomes were hormonal and metabolic profile changes in addition to ovulation and first trimester (13 weeks) miscarriage rates. Clomiphene-citrate, L-carnitine, and metformin group showed significant improvement in the menstrual regularity, ovulation rate, and pregnancy rate compared to CC plus metformin and placebo group (29% vs. 9%, 34.7% vs.11%, and 28.2% vs. 6.6%, respectively). No statistically significant difference in the miscarriage rate between the two groups (p = .08). After three months of treatment, the reduction in body mass index (BMI) was non-significant (p = .061) between both groups. The hormonal and metabolic parameters were more significantly improved in the L-carnitine group compared with the placebo group. l-Carnitine may act synergistically with metformin for improvement of reproductive performance, insulin resistance, and lipid profile in clomiphene-resistant obese PCOS women.

摘要

为了探讨左旋肉碱联合二甲双胍对克罗米芬（CC）耐药的肥胖多囊卵巢综合征（PCOS）女性生殖代谢的影响。在一项双盲随机对照临床试验中, 克罗米芬-柠檬酸耐药的肥胖女性被随机分配接受CC +二甲双胍+左旋肉碱治疗（n = 138）或CC +二甲双胍+安慰剂治疗（n = 136）。主要结局指标是临床妊娠率。次要结局指标是排卵和妊娠早期（13周）的流产率及激素和代谢谱的变化。与CC +二甲双胍组+安慰剂组相比, 枸橼酸克罗米芬+左旋肉碱+二甲双胍组在月经规律、排卵率和妊娠率方面均有显著改善（分别为29% vs. 9%、34.7% vs.11%和28.2% vs. 6.6%）。两组流产率差异无统计学意义（p=.08）。治疗3个月后, 两组患者的体重指数（BMI）均无显著下降（p= .061）。与安慰剂组相比, 左旋肉碱组的激素和代谢参数明显改善。左旋肉碱可与二甲双胍协同作用, 改善克罗米芬耐药肥胖多囊卵巢综合征女性的生殖功能、胰岛素抵抗和血脂水平。

The Chinese abstracts are translated by Prof. Dr. Xiangyan Ruan and her team: Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing 100026, China.

Keywords:

• l-Carnitine
• metformin
• obese
• polycystic ovary syndrome
• reproductive effect
• metabolic effect

Acknowledgments

We acknowledge the residents and nursing staff who helped in this study.

Disclosure statement

The authors have no conflict of interest to disclose.