Sequential therapy for infertility in women with polycystic ovary syndrome and luteal phase defects by Yangxin Dianji decoction (养心奠基方) and Nuangong Tiaojing decoction (暖宫调经方): a real-world study

doi:10.19852/j.cnki.jtcm.2025.05.016

Abstract

Abstract:

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 (养心奠基方, YXDJ-D) and Nuangong Tiaojing decoction (暖宫调经方, 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.

Key words: infertility, polycystic ovary syndrome, luteal phase defect, endometrial receptivity, Yangxin Dianji decoction, Nuangong Tiaojing decoction

JIANG Xiaoyue, DIING Yinyin, LIU Xinyuan, RUAN Fang, ZOU Yeting, HONG Yanli, ZHOU Huifang. Sequential therapy for infertility in women with polycystic ovary syndrome and luteal phase defects by Yangxin Dianji decoction (养心奠基方) and Nuangong Tiaojing decoction (暖宫调经方): a real-world study[J]. Journal of Traditional Chinese Medicine, 2025, 45(5): 1098-1105.

Figures/Tables 5

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General character	Exposed group A (n = 30)	Exposed group B (n = 30)	Control group (n = 30)	F value	P value
Age (years)	30.7±3.3	29.2±2.8	30.2±4.1	1.566	0.215
Height (cm)	161.5±3.6	161.4±5.5	162.4±4.4	0.419	0.659
Weight (kg)	57.6±7.5	62.3±10.2	58.0±10.2	2.308	0.106
BMI (kg/m²)	22.1±2.8	24.0±4.4	22.0±3.6	2.870	0.062
Secondary infertility [n (%)]	14.0 (46.7)	12.0 (40.0)	11.0 (36.7)	0.643	0.725
Primary infertility [n (%)]	16.0 (53.30)	18.0 (60.0)	19.0 (63.3)	0.643	0.725

General character	Exposed group A (n = 30)	Exposed group B (n = 30)	Control group (n = 30)	F value	P value
Age (years)	30.7±3.3	29.2±2.8	30.2±4.1	1.566	0.215
Height (cm)	161.5±3.6	161.4±5.5	162.4±4.4	0.419	0.659
Weight (kg)	57.6±7.5	62.3±10.2	58.0±10.2	2.308	0.106
BMI (kg/m²)	22.1±2.8	24.0±4.4	22.0±3.6	2.870	0.062
Secondary infertility [n (%)]	14.0 (46.7)	12.0 (40.0)	11.0 (36.7)	0.643	0.725
Primary infertility [n (%)]	16.0 (53.30)	18.0 (60.0)	19.0 (63.3)	0.643	0.725

Symptom	Time	Exposed group A (n = 30)	Exposed group B (n = 30)	Control group (n = 30)	Z/χ2/F value	P value
Premenstrual backache	Pre-treatment	3.00 (2.25, 6.00)	3.00 (3.00, 9.00)	3.00 (3.00, 3.75)	1.074	0.584
Premenstrual backache	Post-treatment	0.00 (0.00, 3.00)^ab	0.00 (0.00, 0.00)^ab	3.00 (3.00, 3.00)	14.026	0.001
Breast swelling and pain	Pre-treatment	3.00 (3.00, 6.00)	3.00 (0.00, 6.00)	3.00 (0.00, 6.00)	4.093	0.129
Breast swelling and pain	Post-treatment	0.00 (0.00, 3.00)^a	0.00(0.00, 0.00)	3.00 (0.00, 3.00)	6.031	0.049
Cold intolerance	Pre-treatment	3.00 (0.00, 6.00)	3.00 (3.00, 6.00)	3.00 (0.00, 3.00)	4.905	0.086
Cold intolerance	Post-treatment	0.00 (0.00, 3.00)^ac	0.00 (0.00, 0.00)^bd	3.00 (0.00, 3.00)	14.418	0.001
Depression or irritability	Pre-treatment	3.00 (0.00, 6.00)	3.00 (0.00, 6.00)	3.00 (3.00, 6.00)	1.262	0.532
Depression or irritability	Post-treatment	0.00 (0.00, 3.00)^ac	0.00 (0.00, 3.00)^bd	3.00 (0.00, 3.00)	6.465	0.039
Insomnia	Pre-treatment	3.00 (0.00, 3.00)	3.00 (3.00, 6.00)	3.00 (0.00, 3.00)	2.651	0.266
Insomnia	Post-treatment	0.00 (0.00, 3.00)^a	0.00 (0.00, 1.50)^a	0.00(0.00, 0.00)^a	2.651	0.266
Dysmenorrhea	Pre-treatment	3.00 (0.00, 3.00)	3.00 (3.00, 6.00)	3.00 (3.00, 3.00)	2.651	0.266
Dysmenorrhea	Post-treatment	0.00 (0.00, 0.00)^a	0.00 (0.00, 1.50)^a	0.00 (0.00,0.00)^a	2.651	0.266
Total TCM symptom score	Pre-treatment	24.90±11.00	21.80±9.08	20.40±8.05	1.778	0.175
Total TCM symptom score	Post-treatment	8.40±9.91^ab	7.20±9.21^ab	13.10±7.58^a	3.890	0.024

Symptom	Time	Exposed group A (n = 30)	Exposed group B (n = 30)	Control group (n = 30)	Z/χ2/F value	P value
Premenstrual backache	Pre-treatment	3.00 (2.25, 6.00)	3.00 (3.00, 9.00)	3.00 (3.00, 3.75)	1.074	0.584
Premenstrual backache	Post-treatment	0.00 (0.00, 3.00)^ab	0.00 (0.00, 0.00)^ab	3.00 (3.00, 3.00)	14.026	0.001
Breast swelling and pain	Pre-treatment	3.00 (3.00, 6.00)	3.00 (0.00, 6.00)	3.00 (0.00, 6.00)	4.093	0.129
Breast swelling and pain	Post-treatment	0.00 (0.00, 3.00)^a	0.00(0.00, 0.00)	3.00 (0.00, 3.00)	6.031	0.049
Cold intolerance	Pre-treatment	3.00 (0.00, 6.00)	3.00 (3.00, 6.00)	3.00 (0.00, 3.00)	4.905	0.086
Cold intolerance	Post-treatment	0.00 (0.00, 3.00)^ac	0.00 (0.00, 0.00)^bd	3.00 (0.00, 3.00)	14.418	0.001
Depression or irritability	Pre-treatment	3.00 (0.00, 6.00)	3.00 (0.00, 6.00)	3.00 (3.00, 6.00)	1.262	0.532
Depression or irritability	Post-treatment	0.00 (0.00, 3.00)^ac	0.00 (0.00, 3.00)^bd	3.00 (0.00, 3.00)	6.465	0.039
Insomnia	Pre-treatment	3.00 (0.00, 3.00)	3.00 (3.00, 6.00)	3.00 (0.00, 3.00)	2.651	0.266
Insomnia	Post-treatment	0.00 (0.00, 3.00)^a	0.00 (0.00, 1.50)^a	0.00(0.00, 0.00)^a	2.651	0.266
Dysmenorrhea	Pre-treatment	3.00 (0.00, 3.00)	3.00 (3.00, 6.00)	3.00 (3.00, 3.00)	2.651	0.266
Dysmenorrhea	Post-treatment	0.00 (0.00, 0.00)^a	0.00 (0.00, 1.50)^a	0.00 (0.00,0.00)^a	2.651	0.266
Total TCM symptom score	Pre-treatment	24.90±11.00	21.80±9.08	20.40±8.05	1.778	0.175
Total TCM symptom score	Post-treatment	8.40±9.91^ab	7.20±9.21^ab	13.10±7.58^a	3.890	0.024

Item	Time	Exposed group A (n = 30)	Exposed group B (n = 30)	Control group (n = 30)	Z/χ2/F value	P value
E₂ (ng/L)	Pre-treatment	165.00 (119.25, 231.25)	167.00 (94.75, 203.50)	187.15 (139.03, 221.50)	1.543	0.462
E₂ (ng/L)	Post-treatment	209.50 (140.75, 250.75)^a	226.00 (145.00, 300.75)^b	225.00 (161.33, 71.75)^a	1.305	0.521
P (ng/mL)	Pre-treatment	8.98 (6.30, 10.71)	9.59 (6.85, 15.51)	7.43 (5.35, 12.68)	2.589	0.274
P (ng/mL)	Post-treatment	12.91 (8.59, 17.42)^b	22.45 (15.52, 29.39)^bc	13.00 (8.62, 24.96)^a	14.578	0.001
EV (mL)	Pre-treatment	2.64 (2.16, 3.38)	2.70 (2.15, 3.81)	3.06 (2.29, 3.91)	0.928	0.629
EV (mL)	Post-treatment	3.57 (2.69, 5.49)^bc	3.86 (3.10, 5.25)^bc	2.66 (2.02, 3.75)	12.316	0.002
VI	Pre-treatment	0.88 (0.21, 2.21)	0.82 (0.10, 2.91)	2.14 (0.48, 2.94)	3.776	0.151
VI	Post-treatment	2.30 (1.04, 3.25)^b	2.18 (0.50, 4.36)	1.31 (0.60, 2.71)	1.879	0.391
FI	Pre-treatment	19.11 (10.42, 23.70)	19.35 (16.60, 24.22)	21.64 (10.00, 25.28)	0.278	0.870
FI	Post-treatment	24.2 (20.28, 26.07)^bc	24.70 (22.60, 28.67)^bc	20.57 (13.20, 24.20)	14.95	0.001
VFI	Pre-treatment	0.10 (0.02, 0.38)	0.07 (0.02, 0.59)	0.23 (0.04, 0.55)	1.428	0.490
VFI	Post-treatment	0.79 (0.33, 1.10)^bc	0.90 (0.18, 1.37)^bc	0.26 (0.06, 0.63)	10.974	0.004

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