Trial One
Objectives: 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.
Methods: 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.
Results: 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).
Conclusions: 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.
Trial Two
In 20016 a Chinese Clinical trial studied the effects of a Chinese herbal formula on infertile women under going IVF.
Treatment method:
Members of both groups went through the standard preparatory treatment for IVF. In addition, the treatment group started taking herbs from day three in their menstrual cycle throughout the cycle up to the day of HCG administration.[1] The members of the treatment group were orally administered 10 grams each time, three times per day of Er Zhi Tian Gui Ke Li (Two Ultimates Tian Gui Granules). This consisted of unspecified amounts and/or proportions of:
Nu Zhen Zi (Fructus Ligustri Lucidi)
Han Lian Cao (Herba Ecliptae)
Gou Qi Zi (Fructus Lycii)
Tu Si Zi (Semen Cuscutae)
Dang Gui (Radix Angelicae Sinensis)
Bai Shao (Radix Paeoniae Albae)
Sheng Di (uncooked Radix Rehmanniae)
Chuan Xiong (Rhizoma Chuanxiong)
processed Xiang Fu (Rhizoma Cyperi)
Gan Cao (Radix Glycyrrhizae)
More about participants
Altogether, there were 122 patients enrolled in this two-wing comparison study, all of whom suffered from infertility and were being treated with IVF. These 122 patients were randomly divided into two groups of 61 women each, a treatment group and a comparison group. In the treatment group, 20 women were 25-29 years old, 32 were 30-34 years old, and nine were35-39 years old. In the comparison group, the numbers of cases these ages were 18, 36, and seven cases respectively. In the treatment group, 20 cases had been infertile for 1-2 years, 25 cases had been infertile for 3-4 years, seven cases had been infertile for 5-6, and nine cases had been infertile for seven or more years. In the comparison group, these numbers were 18, 21, nine, and 13 respectively. In the treatment group, there were 37 cases of primary infertility and 24 cases of secondary infertility. In the comparison group, these numbers were 40 and 21 respectively. Therefore, in terms of age, duration of infertility, and type of infertility, these two groups were considered statistically comparable for the purposes of this study. In addition, all these women met the criteria for kidney qi and yin dual vacuity infertility. Exclusion criteria included use of sex hormones within three months, cardiovascular, liver, or kidney disease, neurological or psychiatric disturbances, or and allergic constitution.
References
Trial One
Lian Fang, Wang Rui-Xia, Ma Feng-Mei, Sun Zhen-Gao, Wang Li-Hong, and Shi Lei. The Journal of Alternative and Complementary Medicine. April 2013, 19(4): 353-359. doi:10.1089/acm.2011.0410.
Trial Two
On pages 439-441 of issue #6, 2006 of the Zhong Yi Za Zhi (Journal of Chinese Medicine), Lian Fang et al. published an article titled, “A Clinical Study on the Treatment of 61 Cases of Infertility with Er Zhi Tian Gui Ke Li (Two Ultimates Tian Gui Granules) Combined with In Vitro Fertilization.” A summary of this article is presented below.
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