Cheraghi Ebrahim, Soleimani Mehranjani Malek, Shariatzadeh Mohammad Ali, Nasr Esfahani Mohammad Hossein, Ebrahimi Zahra
Medical Sciences Research Laboratory, Department of Biology, Faculty of Science, Arak University, Arak, Iran.
Department of Biology, Faculty of Science, Arak University, Arak, Iran.
Int J Fertil Steril. 2014 Jul;8(2):119-28. Epub 2014 Jul 8.
Studies have demonstrated the efficacy of metformin (MTF ) in reducing insulin resistance and N-acetyl cysteine (NAC) in inhibiting oxidative stress which are involved in the pathogenesis of polycystic ovarian syndrome (PCOS). We aimed to compare the effects of MTF and NAC combination on serum metabolite and hormonal levels during the course of ovulation induction in PCOS individual candidates of intracytoplasmic sperm injection (ICSI).
In this prospective randomized clinical trial, placebo con- trolled pilot study, 80 patients of polycystic ovarian syndrome at the age of 25-35 years were divided into 4 groups (n=20): i. NAC=treated with N-acetyl cysteine (600 mg three times daily), ii. MTF=treated with metformin (500 mg three times daily), iii. MTF+NAC=treated with N-acetyl cysteine plus metformin (the offered doses) and iv. placebo (PLA). A total number of 20 patients (6 from MTF group, 4 from NAC group, 6 from MTF+NAC group and 4 from PLA group) were dropped of the study. The drugs were administrated from day 3 of menses of previous cycle until ovum pick-up.
Serum levels of luteinizing hormone (LH), total testosterone, cholester- ol and triglyceride, insulin and leptin significantly reduced in the MTF and NAC groups compared to the placebo (p<0.01). But levels of LH, total testosterone, cholesterol and triglyceride had no significant reduction in the MTF+NAC groups compared to the placebo. The serum levels of malonyldialdehyde (MDA), insulin and leptin reduced significantly after treatment in the MTF+NAC group compared to the placebo (p<0.05).
CONSIDERING THE ADVERSE EFFECT OF COMBINATION THERAPY, WE PROPOSED THE CONADMINISTRATION MIGHT HAVE NO BENEFICIAL EFFECT FOR PCOS PATIENT DURING COURSE OF OVULATION INDUCTION OF ICSI (REGISTRATION NUMBER: IRCT201204159476N1).
研究表明二甲双胍(MTF)在降低胰岛素抵抗方面具有疗效,而N - 乙酰半胱氨酸(NAC)在抑制氧化应激方面具有作用,这些均与多囊卵巢综合征(PCOS)的发病机制相关。我们旨在比较MTF与NAC联合用药对接受卵胞浆内单精子注射(ICSI)的PCOS个体候选者在促排卵过程中血清代谢物和激素水平的影响。
在这项前瞻性随机临床试验、安慰剂对照的初步研究中,80例年龄在25 - 35岁的多囊卵巢综合征患者被分为4组(n = 20):i. NAC组 = 接受N - 乙酰半胱氨酸治疗(每日三次,每次600毫克);ii. MTF组 = 接受二甲双胍治疗(每日三次,每次500毫克);iii. MTF + NAC组 = 接受N - 乙酰半胱氨酸加二甲双胍治疗(上述剂量);iv. 安慰剂(PLA)组。共有20例患者(MTF组6例、NAC组4例、MTF + NAC组6例、PLA组4例)退出研究。药物从前一周期月经第3天开始服用直至取卵。
与安慰剂组相比,MTF组和NAC组的促黄体生成素(LH)、总睾酮、胆固醇和甘油三酯、胰岛素及瘦素的血清水平显著降低(p < 0.01)。但与安慰剂组相比,MTF + NAC组的LH、总睾酮、胆固醇和甘油三酯水平无显著降低。与安慰剂组相比,MTF + NAC组治疗后丙二醛(MDA)、胰岛素及瘦素的血清水平显著降低(p < 0.05)。
考虑到联合治疗的不良反应,我们提出在ICSI促排卵过程中,联合用药对PCOS患者可能没有益处(注册号:IRCT201204159476N1)。