Sequential therapy for infertility in women with polycystic ovary syndrome and luteal phase defects by Yangxin Dianji decoction and Nuangong Tiaojing decoction: a real-world study.

Objective: To evaluate the effectiveness and safety of the sequential therapy in treating infertility with polycystic ovary syndrome (PCOS) and luteal phase defects (LPD) by Yangxin Dianji decoction (, YXDJ-D) and Nuangong Tiaojing decoction (, NGTJ-D).

Methods: This study was undertaken in the Jiangsu Province Hospital of Chinese Medicine. Altogether 90 eligible patients with PCOS and LPD were assigned to exposed group A (Chinese Medicine therapy, YXDJ-D and NGTJ-D), exposed group B (Chinese Medicine plus Western Medicine therapy), control group (Western Medicine therapy). The exposed group A adopted the sequential therapy that YXDJ-D is taken in the postmenstrual period (follicular phase) and NGTJ-D is taken in premenstrual period (luteal phase). Control group took letrozole, dydrogesterone and was given intramuscular injection of human menopausal gonadotropin, human chorionic gonadotropin. The exposed group B was treated with the above-mentioned therapy project of integrated Chinese Medicine and Western Medicine. This study lasted for 2 courses for 6 months. The primary outcomes were pregnancy rate and early abortion rate. The secondary outcomes were the Traditional Chinese Medicine (TCM) syndrome scores, estrogen (E₂) and progesterone (P), endometrial volume (EV), vascularity index (VI), flow index (FI) and vascularization flow index (VFI). These outcomes will be assessed at baseline and post-intervention.

Results: The pregnancy rates of the exposed group A and B were higher than the control group (60.00% vs 60.00% vs 53.33%), while early abortion rates of exposed groups A and B were lower than the control group (33.33% vs 16.67% vs 43.75%, P > 0.05). Total efficacy rates in exposed group A and B were better than the control group (93.30% vs 93.30% vs 53.30%, P < 0.01). TCM symptom scores and endometrial receptivity indexes (EV, FI, VFI) were significantly lower in exposed groups compared to the control group (P < 0.05). P increase in exposed group B was superior to the other two groups (P < 0.01). No noticeable abnormalities in safety indicators in the three groups.

Conclusion: The sequential therapy of YXDJ-D and NGTJ-D can effectively increase pregnancy rate, reduce the early abortion rate and alleviate the clinical symptoms of infertility in patients with PCOS and LPD by improving luteal function and promoting the endometrial receptivity.