Comparison of metformin plus myoinositol vs metformin alone in PCOS women undergoing ovulation induction cycles: randomized controlled trial

Abstract

The present study was planned to evaluate the benefit of synergetic effect of Metformin plus Myo-inositol versus Metformin alone in infertile polycystic ovarian syndrome (PCOS) women undergoing ovulation induction. One hundred and twenty infertile PCOS women were randomized: Group I (n = 60) received Metformin (500 mg) plus Myoinositol(600 mg) three times a day; Group II received Metformin 500 mg three times a day. Subjects were advised to try for spontaneous conception. Those who did not conceive after 3 months, were given three cycles of ovulation induction + intrauterine insemination. Hormonal and biochemical profile parameters were done at baseline and after 3 months of therapy. Primary outcome measure was live birth rate. Secondary outcomes were improvement in menstrual cycle, hormonal and biochemical parameters, spontaneous conception, abortions, multiple pregnancy, and ovarian hyperstimulation syndrome. Baseline demographic, hormonal and biochemical parameters were comparable in two groups. There was a significant improvement in menstrual cycles (cycle length and bleeding days) in Group I as compared to Group II. The improvement in biochemical and hormonal parameters were comparable in the two groups after 3 months. Live birth rate was significantly higher in the Group I as compared to Group II [55% (33/60); 26.67% (16/60); p = .002]. The study concluded significantly higher live birth rate in women receiving the combination as compared to metformin alone.

摘要

本研究拟评价二甲双胍联合肌醇与二甲双胍单独应用于不孕的多囊卵巢综合征（PCOS）的女性促排卵的疗效。将120名不孕的PCOS的女性随机分为两组：第一组（n＝60）服用二甲双胍（500mg）+肌醇（600mg）, 一天三次；第二组服用二甲双胍500mg, 一天三次。建议受试者尝试自然受孕, 三个月后仍未怀孕者给与三个周期的促排卵治疗+人工授精。治疗前和治疗三个月后分别进行激素水平及生化指标的检测。评估结局的主要方法是活产率。其次包括月经周期、激素水平和生化指标、自然受孕、流产、多胎妊娠和卵巢过度刺激综合征。两组的基础人口统计学, 激素水平和生化指标具有可比性。与第二组相比, 第一组的月经周期（周期长度和出血天数）明显改善。三个月后, 与第二组相比第一组的胰岛素抵抗显著改善（p＝0.03）。I组的活产率显著高于II组的活产率[55% (33/60)；26.67% (16/60)；p＝0.002]。本研究的结论：与单独服用二甲双胍相比, 接受联合用药的女性活产率显著提高。

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:

• Infertility
• PCOS
• metformin
• myoinositol
• OHSS

Acknowledgement

All the authors agree with the interpretations/conclusions of this paper. The study has no financial relationship with any organization. The authors would like to acknowledge Erislifesciences Ltd. (Montana Div) Pharmaceuticals for providing free drug samples used in this study.

Disclosure statement

No financial relationship with any organization. Authors have full control of all primary data. Informed written consent was obtained from the patients for publication. The authors report no conflicts of interest.