ABSTRACT
<p><b>OBJECTIVE</b>To observe the clinical curative effect of Wenshen Yangxue Granule (WSYXG) combined with clomifene citrate (CC) in treating follicular maldevelopment (FM) infertility, and to explore its possible action channels.</p><p><b>METHODS</b>Ninety patients with FM of Shen-deficiency blood stasis syndrome were randomly assigned to 3 groups, i.e., the Chinese medicine group (CMG, treated with WXYXG), the Western medicine group (WMG, treated with CC), and the combination group of Chinese medicine and Western medicine (CG, treated with both WSYXG and CC), 30 cases in each group. Three menstrual cycles were totally observed. Serum levels of luteinizing hormone (LH), follicle stimulating hormone (FSH), estradiol (E2 ), inhibin B (INHB), activin A (ACTA), and follistatin (FS) were tested before and after treatment, and the ovulation was monitored and their basic body temperature measured.</p><p><b>RESULTS</b>There was no statistical difference in clinical efficacy among the three groups (P> 0.05). Better effects on the Chinese medicine syndrome efficacy, the ovulation rate, and the endometrium thickness on the ovulation day were shown in CMG and CG than in WMG, showing statistical difference (P < 0.05). The E2 level increased on the third day of the first menstrual cycle in CG when compared with before treatment. On the 10th day of the 1st menstrual cycle, the INHB and FS increased and the ACTA decreased, showing statistical difference (P < 0.05). On the 10th day of the 3rd menstrual cycle the serum LH level decreased more obviously in CG than in WMG, showing statistical difference (P < 0.05). On the 3rd day of the 3rd menstrual cycle in CG, the INHB was negatively correlated with FSH (r = -0.492,P < 0.01), and INHB on the 10th day was positively correlated with E2 and FS (r = 0.682, 0.772, P < 0.01), and negatively correlated with ACTA on the 10th day (r = -0.635, P < 0.01).</p><p><b>CONCLUSION</b>WSYXG combined with CC could improve Chinese medicine syndrome, regulate the expressions of FM patients' ovary local factors INHB, ACTA and FS, improve the condition of ovary functions, and control the follicle development.</p>