Integrative Medicine Research Centre of Reproduction and Heredity, Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Jinan, China.
J Altern Complement Med. 2013 Apr;19(4):353-9. doi: 10.1089/acm.2011.0410. Epub 2012 Oct 17.
The purpose of this study was to explore the effects of Erzhi Tiangui Granule (ETG) on DNA methyltransferases (DNMT) 1 protein expression in endometrium of infertile women with Kidney-yin Deficiency syndrome.
A randomized, double-blinded, placebo-controlled clinical trial was conducted. Sixty-six (66) infertile patients who had Kidney-yin Deficiency syndrome and who were to undergo in vitro fertilization-embryo transfer (IVF-ET) were randomly assigned to either a treatment group or a control group according to a random table. Besides gonadotropin (Gn) therapy in both groups, the treatment group received ETG for 3 menstrual cycles before IVF, and the control group received placebo granules. The ETG and the placebo granules were made with similar color and shape, as well as in the same packaging. The scores of the Kidney-yin Deficiency syndrome were assessed. Other outcome measures included the dosage and duration of Gn, the number of retrieved oocytes, the rate of high-quality oocytes, the rate of high-quality embryos, the fertilization rate, and the clinical pregnancy rate. DNMT1 protein expression in the endometrium was measured in the midluteal phase.
The difference in the syndrome score change before and after treatment between the two groups was statistically significant (p<0.05). The dosage and duration of Gn were significantly lower in the treatment group than those in the control group (p<0.05). The high-quality oocyte and embryo rates, and clinical pregnancy rate were all higher in the treatment group than those in the control group (p<0.05). The fertilization rate was not significant when compared to the placebo group. No difference was found in the number of retrieved oocytes between the two groups. The DNMT1 protein expression in the endometrium was much more abundant in the treatment group than that in the control group (p<0.05).
For the infertile patients undergoing IVF, the Chinese recipe for tonifying the Kidney as an adjunct treatment could reduce Gn dosage and treatment duration, alleviate clinical symptoms, and improve the clinical pregnancy rate. The increased level of DNMT1 protein expression after treatment may lead to enhanced endometrial receptivity. This finding may explain the improvement in clinical pregnancy rate.
本研究旨在探讨二至天癸颗粒（ETG）对肾虚型不孕患者子宫内膜 DNA 甲基转移酶（DNMT）1 蛋白表达的影响。
采用随机、双盲、安慰剂对照的临床试验。根据随机表，将 66 例肾虚型不孕患者随机分为治疗组和对照组。两组均给予促性腺激素（Gn）治疗，治疗组在 IVF-ET 前 3 个月经周期给予 ETG 治疗，对照组给予安慰剂颗粒。ETG 和安慰剂颗粒采用相似的颜色和形状，并采用相同的包装。评估肾虚证的评分。其他结局指标包括 Gn 的剂量和持续时间、获卵数、优质卵率、优质胚胎率、受精率和临床妊娠率。在黄体中期测量子宫内膜 DNMT1 蛋白的表达。
两组治疗前后证候评分变化差异有统计学意义（p<0.05）。治疗组 Gn 的剂量和持续时间明显低于对照组（p<0.05）。治疗组优质卵率、优质胚胎率和临床妊娠率均高于对照组（p<0.05）。与安慰剂组相比，受精率无显著差异。两组获卵数无差异。治疗组子宫内膜 DNMT1 蛋白表达明显多于对照组（p<0.05）。
对于接受 IVF 的不孕患者，补肾中药方剂作为辅助治疗可减少 Gn 剂量和治疗时间，缓解临床症状，提高临床妊娠率。治疗后 DNMT1 蛋白表达水平的增加可能导致子宫内膜容受性增强。这一发现可能解释了临床妊娠率的提高。
