Journal of Traditional Chinese Medicine ›› 2025, Vol. 45 ›› Issue (5): 1098-1105.DOI: 10.19852/j.cnki.jtcm.2025.05.016
• Original Articles • Previous Articles Next Articles
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
JIANG Xiaoyue1,2, DIING Yinyin1,2, LIU Xinyuan1,2, RUAN Fang1,2, ZOU Yeting2, HONG Yanli3(
), ZHOU Huifang2()
- 1 the First School of Clinical Medicine, Nanjing University of Chinese Medicine, Nanjing 210023, China
2 Department of Gynecology, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing 210029, China
3 Department of Reproductive Medicine, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing 210029, China
-
Received:2024-08-12Accepted:2025-02-25Online:2025-10-15Published:2025-09-15 -
Contact:Dr HONG Yanli, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing 210029, China. 15951711586@126.com;
Prof. ZHOU Huifang, Affiliated Hospital of Nanjing University of Chinese Medicine, Nanjing 210029, China. zhouhuifang2011301@163.com.,Telephone: +86-15951711586; +86-13851858108 -
Supported by:National Natural Science Foundation of China: Elucidation of a New Mechanism of the Prescription for Reinforcing Kidney and Promoting Pregnancy (Bushen Zhuyun Decoction) in Treating Luteal Phase Defects Infertility based on Coenzyme Q10/Ubiquinol Mediated New Ferroptosis Pathway in Endometrium During Implantation(82474567);Jiangsu Province Key Research and Development Plan (Society Development) Project: a Multicenter Real-world Study of Sequential Treatment of Luteal Phase Defects Infertility with “Improving Endometrial Receptivity” as the Effect Point(BE2021726);Project of Clinical Innovation Center of Traditional Chinese Medicine in Jiangsu Province: Clinical And Basic Research on the Treatment of Luteal Phase Defects Infertility with “Improving Endometrial Receptivity” as the Effect Point(k2021j18-1)
Cite this article
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.
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Figure 1 Flow diagram of the study
Figure 1 Flow diagram of the study
Table 1 Baseline characteristics in the three groups
| 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) |
Table 1 Baseline characteristics in the three groups
| 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) |
Table 2 TCM symptom score before and after treatment
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Post-treatment | 8.40±9.91ab | 7.20±9.21 ab | 13.10±7.58a | 3.890 | 0.024 |
Table 2 TCM symptom score before and after treatment
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Post-treatment | 8.40±9.91ab | 7.20±9.21 ab | 13.10±7.58a | 3.890 | 0.024 |
Table 3 Changes in serum indexes and endometrial receptivity indicators
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Table 3 Changes in serum indexes and endometrial receptivity indicators
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Table 4 Adverse events in process of treatment [n (%)]
| Any adverse events | Exposed group A (n = 30) | Exposed group B (n = 30) | Control group (n = 30) |
|---|---|---|---|
| Increased aspart aminotransferase | 1 (3.33) | 2 (6.67) | 1 (3.33) |
| Increased alanine aminotransferase | 0 | 3 (10.00) | 2 (6.67) |
| Increased uric acid | 0 | 4 (13.33) | 2 (6.67) |
| Nausea and vomiting | 0 | 1 (3.33) | 3 (10.00) |
| Dizziness | 0 | 1 (3.33) | 2 (6.67) |
| Headache | 0 | 0 | 0 |
| Increased white blood cell | 2 (6.67) | 6 (20.00) | 5 (16.67) |
| Increased red blood cell | 2 (6.67) | 3 (10.00) | 1 (3.33) |
| Increased blood platelet | 2 (6.67) | 6 (20.00) | 6 (20.00) |
| Increased neutrophil granulocyte | 3 (10.00) | 5 (16.67) | 3 (10.00) |
Table 4 Adverse events in process of treatment [n (%)]
| Any adverse events | Exposed group A (n = 30) | Exposed group B (n = 30) | Control group (n = 30) |
|---|---|---|---|
| Increased aspart aminotransferase | 1 (3.33) | 2 (6.67) | 1 (3.33) |
| Increased alanine aminotransferase | 0 | 3 (10.00) | 2 (6.67) |
| Increased uric acid | 0 | 4 (13.33) | 2 (6.67) |
| Nausea and vomiting | 0 | 1 (3.33) | 3 (10.00) |
| Dizziness | 0 | 1 (3.33) | 2 (6.67) |
| Headache | 0 | 0 | 0 |
| Increased white blood cell | 2 (6.67) | 6 (20.00) | 5 (16.67) |
| Increased red blood cell | 2 (6.67) | 3 (10.00) | 1 (3.33) |
| Increased blood platelet | 2 (6.67) | 6 (20.00) | 6 (20.00) |
| Increased neutrophil granulocyte | 3 (10.00) | 5 (16.67) | 3 (10.00) |
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