SUMMARY: In this study, 90 patients with infertility due to luteal phase defect were divided into the control group and treatment group according to the random number table methods. All subjects met the diagnostic criteria of infertility due to luteal phase defect according to the “Gynecology of Traditional Chinese Medicine”. There was no significant difference in age, course of disease and etiology of disease, and the two groups were therefore statistically comparable (P>0.05).
In the control group, subjects received oral clomiphene citrate tablets 50mg (Jiangsu Hengrui Pharmaceutical Co., Ltd.) or 2.5mg of letrozole from day 5 of menstruation (Codal. Synto Limited), once a day for 5 days. Once ovulation is confirmed by B-ultrasound, subjects received oral dydrogesterone tablets (Abbott Biologicals B. V.), 10 mg twice a day for 14 days.
In treatment group, subjects received the Nourishing Kidney and Soothing Liver Formula (補腎疏肝方) 200ml twice a day (morning and evening) for 21 days, starting from day 5 of the subject’s menstrual period. The ingredients of the formula included: Bai Shao 25g (白芍 Radix Paeoniae Alba), Fu Ling 20g (茯苓 Poria), Dang Gui 20g (當歸 Radix Angelicae Sinensis), He Shou Wu 20g (何首烏 Radix Polygoni Multiflori), Huang Qi 20g (黃耆 Radix Astragali seu Hedysari), Tu Si Zi 15g (菟蕬子 Semen Cuscutae), Shu Di Huang 15g (熟地黃 Radix Rehmanniae Praeparata), Dan Shen 15g (丹參 Radix Salviae Miltiorrhizae), Nu Zhen Zi 15g (女貞子 Fructus Ligustri Lucidi), Mu Gua 15 g(木瓜 Fructus Chaenomelis), Shi Chang Pu 10g (石菖蒲 Rhizoma Acori Graminei), Chuan Xiong 10g (川芎 Rhizoma Ligustici Chuanxiong), Chai Hu 10g (柴胡 Radix Bupleuri) and Gan Cao 6g (甘草 Radix Glycyrrhizae). Once ovulation is confirmed by B-ultrasound, subjects also received oral dydrogesterone tablets, 10 mg twice a day for 14 days.
To evaluate the clinical efficacy, the clinical signs and symptoms, ovarian hormone levels (blood estradiol [E2] and progesterone [P] on day 7 after ovulation), the maximum diameter of the dominant follicle and endometrial thickness were measured before and after treatment.
The result was considered as: 1). Markedly effective: signs and symptoms resolved after treatment, laboratory markers returned to normal range; 2). Effective: signs and symptoms significantly relieved after treatment, laboratory markers improved; 3). Ineffective: signs and symptoms did not improve, or even exacerbated after the treatment
Table 1. Comparison of Clinical Efficacy in Treating Infertility due to Luteal Phase Defect between Treatment Group and Control Group
| Group | n | Markedly Effective | Effective | Ineffective | Total Effective Rate (%) |
| Treatment | 45 | 27 (60.00) | 16 (35.56) | 2 (4.44) | 43 (95.56) |
| Control | 45 | 17 (37.78) | 20 (44.44) | 8 (17.78 | 37 (82.22) |
| χ2 | 4.050 | ||||
| P value | 0.044 |
After 14 days of treatment, both treatment and control groups showed significant improvement. In the treatment group, the total effective rate was 95.56%, which was significantly higher than the control group (82.22%) (P<0.05). The result also indicated that the treatment group showed a more significant improvement in E2, P level, the maximum diameter of the dominant follicle and endometrial thickness (P<0.05). This suggested that Nourishing Kidney and Soothing Liver Formula could increase the success rate in treating infertility due to luteal phase defect, potentially by improving the microcirculation of the body, regulate the endocrine function of the reproductive system, and promote the growth of follicles and endometrial development.
Jia Song. Chinese Medicine Modern Distance Education of China. 2022. 20 (10): 82-89