Impact of myoinositol with metformin and myoinositol alone in infertile PCOS women undergoing ovulation induction cycles - randomized controlled trial

Abstract

Purpose

To evaluate the benefits of myoinositol plus metformin versus myoinositol alone in infertile polycystic ovarian syndrome (PCOS) women undergoing ovulation induction cycles.

Materials and methods

Total 116 infertile PCOS women were randomized: Group I (n = 57): metformin (1500 mg) plus myoinositol (4 g) per day; Group II (n=59): myoinositol 4 g per day. Subjects were advised to try for spontaneous conception. Those who did not conceive after three months were given three cycles of ovulation induction. Primary outcome was clinical pregnancy rate after 6 months. Secondary outcomes were improvement in metabolic and endocrine parameters, ongoing pregnancy, abortion and multiple pregnancy rate.

Results

Baseline demographic, metabolic and hormonal parameters were comparable in two groups. After 3 months of therapy, both study groups had comparable improvement in metabolic and hormonal parameters. After 6 months, clinical pregnancy rate was 42.0% in Group I and 45.5% Group II respectively (RR 0.92(95% CI:0.60–1.43) (p > .05). Side-effects (mainly gastrointestinal) were significantly higher in Group I than group II.

Conclusions

Myoinositol (4 g) might be used alone as an insulin sensitizer to improve metabolic, hormonal and reproductive outcome in infertile PCOS women. Further studies with large numbers are warranted to confirm the role of myoinostiol as a sole insulin sensitizer.

摘要

目的：评价肌醇联合二甲双胍与单用肌醇在多囊卵巢综合征(PCOS)促排卵周期中的疗效。材料和方法：116例PCOS不孕女性随机分为两组：I组(n = 57例)：二甲双胍(1500 mg/d)+肌醇(4g/d), II组(n = 59例)：肌醇4g/d。研究人员建议受试者尝试自然受孕。那些在三个月后没有怀孕的人接受了三个周期的促排卵。主要结果是6个月后的临床妊娠率。次要结果是代谢和内分泌参数的改善、持续妊娠、流产和多胎妊娠率。结果：两组的基线人口学、代谢和激素参数具有可比性。经过3个月的治疗, 两个研究组在代谢和激素参数方面都有类似的改善。6个月后, I组和II组的临床妊娠率分别为42.0%和45.5%(RR=0.92(95%CI：0.60∼1.43), P>0.05)。不良反应(主要是胃肠道反应)I组明显高于II组。结论：肌醇(4g)可单独作为胰岛素增敏剂用于改善PCOS不孕女性的代谢、激素和生殖结局。有必要进行大样本量的进一步研究, 确定以肌醇作为唯一的胰岛素增敏剂的作用。

Keywords:

• Metformin
• myoinositol
• PCOS
• infertility
• insulin resistance

Acknowledegment

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 Eris lifesciences Ltd. (Montana Div.) Pharmaceuticals and Akumentis healthcare Ltd. 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.