Advanced Search

Journal of Traditional Chinese Medicine >

2025 , Vol. 45 >Issue 5: 1098 - 1105

DOI: https://doi.org/10.19852/j.cnki.jtcm.2025.05.016

Original 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

  • Xiaoyue JIANG ,
  • Yinyin DIING ,
  • Xinyuan LIU ,
  • Fang RUAN ,
  • Yeting ZOU ,
  • Yanli HONG ,
  • Huifang ZHOU
Expand
  • 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 date: 2024-08-12

  Accepted date: 2025-02-25

  Online published: 2025-09-15

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)

Fold

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

Cite this article

Xiaoyue JIANG , Yinyin DIING , Xinyuan LIU , Fang RUAN , Yeting ZOU , Yanli HONG , Huifang ZHOU . 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 . DOI: 10.19852/j.cnki.jtcm.2025.05.016

References

1. Stańczak NA, Grywalska E, Dudzińska E. The latest reports and treatment methods on polycystic ovary syndrome. Ann Med 2024; 56: 2357737.
2. Duane M, Schliep K, Porucznik CA, Najmabadi S, Stanford JB. Does a short luteal phase correlate with an increased risk of miscarriage? A cohort study. BMC Pregnancy Childbirth 2022; 22: 922.
3. Shi L, Cui L, Yang L, et al. Hotspots and frontiers in luteal phase defect research: an in-depth global trend bibliometric and visualization analysis over a 52-year period. Heliyon 2024; 10: e35088.
4. Dabravolski SA, Nikiforov NG, Eid AH, et al. Mitochondrial dysfunction and chronic inflammation in polycystic ovary syndrome. Int J Mol Sci 2021; 22: 3923.
5. Luan YY, Zhang L, Peng YQ, Li YY, Liu RX, Yin CH. Immune regulation in polycystic ovary syndrome. Clin Chim Acta 2022; 531: 265-72.
6. Palomba S, Piltonen TT, Giudice LC. Endometrial function in women with polycystic ovary syndrome: a comprehensive review. Hum Reprod Update 2021; 27: 584-618.
7. Awonuga AO, Camp OG, Abu-Soud HM. A review of nitric oxide and oxidative stress in typical ovulatory women and in the pathogenesis of ovulatory dysfunction in PCOS. Reprod Biol Endocrinol 2023; 21: 111.
8. Tavaniotou A, Smitz J, Bourgain C, Devroey P. Ovulation induction disrupts luteal phase function. Ann N Y Acad Sci 2001; 943: 55-63.
9. Tesarik J, Conde-López C, Galán-Lázaro M, Mendoza-Tesarik R. Luteal phase in assisted reproductive technology. Front Reprod Health 2020; 2: 595183.
10. Tavaniotou A, Albano C, Smitz J, Devroey P. Impact of ovarian stimulation on corpus luteum function and embryonic implantation. J Reprod Immunol 2002; 55: 123-30.
11. Messinis IE, Messini CI, Dafopoulos K. Luteal-phase endocrinology. Reprod Biomed Online 2009; 19 Suppl 4: 4314.
12. Meenakumari KJ, Agarwal S, Krishna A, Pandey LK. Effects of metformin treatment on luteal phase progesterone concentration in polycystic ovary syndrome. Braz J Med Biol Res 2004; 37: 1637-44.
13. Xue Z, Li J, Feng J, et al. Research progress on the mechanism between polycystic ovary syndrome and abnormal endometrium. Front Physiol 2021; 12: 788772.
14. Mir R, Altayar MA, Hamadi A, et al. Molecular determination of progesterone receptor's PROGINS allele (Alu insertion) and its association with the predisposition and susceptibility to polycystic ovary syndrome (PCOS). Mamm Genome 2022; 33: 508-16.
15. MacLean JA 2nd, Hayashi K. Progesterone actions and resistance in gynecological disorders. Cells 2022; 11: 647.
16. Department of Traditional Chinese Medicine of Shanghai Health Bureau, Jiangsu Provincial Administration of Traditional Chinese Medicine, Zhejiang Provincial Administration of Traditional Chinese Medicine, Jiangsu Provincial Association of Chinese Medicine. Criteria of diagnosis and therapeutic effect of gynecological diseases and syndromes in Traditional Chinese Medicine: ZY/T 001.3-94. Beijing: National Administration of Traditional Chinese Medicine, 1994: 59-73 [accessed October 25, 2023] https://kns.cnki.net/kcms2/article/abstract?v=wScU5_ zS5 CMXbgGG7kZy_lXHV3iJI1O08amNL3VyYmtq8qfJ93bG1guwGDWrzYQcocIDMw0tiaAK-VqbfIJhka3KvembScUjDDVm S2c KtNBpuqP6zFT5DevR6hKqFB6eXm6LaTyPN2g7U5h4amA_zn9PUZdZGp3aA-Wly0hcVWc92nvJ4vxk8A==&uniplatform=N ZKPT&language=CHS .
17. Endocrinology Subgroup and Expert Panel, Chinese Society of Obstetrics and Gyneocology, Chinese Medical Association. Chinese Society of Obstetrics and Gyneocology, Chinese Medical Association. Chinese guideline for diagnosis and management of polycystic ovary syndrome. Zhong Hua Fu Chan Ke Za Zhi 2018; 53: 2-6.
18. Teede HJ, Misso ML, Costello MF, et al. Recommendations from the international evidence-based guideline for the assessment and management of polycystic ovary syndrome. Fertil Steril 2018; 110: 364-79.
19. Practice Committees of the American Society for Reproductive Medicine and the Society for Reproductive Endocrinology and Infertility. Diagnosis and treatment of luteal phase deficiency: a committee opinion. Fertil Steril 2021; 115: 1416-23.
20. Yu J. Practical Obstetrics gynecology of integrated Chinese and Western Medicine. Beijing: Peking University Health Science Center and Peking Union Medical College Press, 1997: 100-5
21. Chen ZJ, Liu JY, Huang HF, et al. Guideline on diagnosis of infertility. Zhong Hua Fu Chan Ke Za Zhi 2019; 54: 505-11.
22. Qiu YL. Clinical study of Bushen Zhuyun decoction the treatment of infertility with luteal dysfunction induced by continuous stress. Nanjing: Nanjing University of Chinese Medicine, 2020: 22-37.
23. Zhang Y, Wang JH, Hu YY, Sao BY, Fu ZJ, Liu JP. Determination of pre-test sample size in clinical research of Traditional Chinese Medicine. J Tradit Chin Med 2021; 62: 307-11.
24. Zheng XY. Guiding principles of clinical research on new drugs of Traditional Chinese Medicine:trial implementation. Beijing: China Medical Science and Technology Press, 2002: 239-43.
25. Zung WW. A rating instrument for anxiety disorders. Psychosomatics 1971; 12: 371-9.
26. Zung WW. A self-rating depression scale. Arch Gen Psychiatry 1965; 12: 63-70.
27. Wang P, Du S, Guo C, et al. The presence of blastocyst within the uteri facilitates lumenal epithelium transformation for implantation via upregulating lysosome proteostasis activity. Autophagy 2024; 20: 58-75.
28. Labarta E, Sebastian-Leon P, Devesa-Peiro A, et al. Analysis of serum and endometrial progesterone in determining endometrial receptivity. Hum Reprod 2021; 36: 2861-70.
29. McCartney CR, Eagleson CA, Marshall JC. Regulation of gonadotropin secretion: implications for polycystic ovary syndrome. Semin Reprod Med 2002; 20: 317-26.
30. Naji M, Nekoonam S, Aleyasin A, et al. Expression of miR-15a, miR-145, and miR-182 in granulosa-lutein cells, follicular fluid, and serum of women with polycystic ovary syndrome (PCOS). Arch Gynecol Obstet 2018; 297: 221-1.
31. Ping L. Formation of corpus luteum and mechanism of luteal insufficiency. Zhong Guo Shi Yong Fu Ke Yu Chan Ke Za Zhi 2021; 37: 412-4.
32. Zhang Y, Xu SY, Liu MN, et al. Comparative studies on chemical contents and effect in kidney-Yang deficiency rats of salt-processed product and wine-processed product of Cuscutae Semen. Evid Based Complement Alternat Med 2019; 2019: 2049497.
33. Hao Q, Wang J, Niu J, et al. Study on phytoestrogenic-like effects of four kinds of Chinese medicine including Radix Rehmanniae Preparata, Radix Paeoniae Alba, Radix Angelicae Sinensis, Rhizoma Chuanxiong. Zhong Guo Zhong Yao Za Zhi 2009; 34: 620-4.
34. Liu PL, Song AR, Dong CD, et al. Network pharmacology study on the mechanism of the herb pair of prepared Rehmannia root-Chinese arborvitae kernel for anxiety disorders. Ann Palliat Med 2021; 10: 3313-27.
35. Li X, Rao Z, Xie Z, Qi H, Zeng N. Isolation, structure and bioactivity of polysaccharides from Atractylodes macrocephala: a review. J Ethnopharmacol 2022; 296: 115506.
36. Luo L, Cai J, Zhou Z, et al. Polysaccharides from Rhizoma Atractylodis Macrocephalae: a review on their extraction, purification, structure, and bioactivities. Evid Based Complement Alternat Med 2022: 2338533.
37. Nai J, Zhang C, Shao H, et al. Extraction, structure, pharmacological activities and drug carrier applications of Angelica sinensis polysaccharide. Int J Biol Macromol 2021; 183: 2337-53.
38. Shan XX, Hong BZ, Liu J, et al. Review of chemical composition, pharmacological effects, and clinical application of Salviae Miltiorrhizae Radix et Rhizoma and prediction of its Q-markers. Zhong Guo Zhong Yao Za Zhi 2021; 46: 5496-11.
39. Bian Z, Zhang W, Tang J, et al. Mechanisms underlying the action of Ziziphi Spinosae Semen in the treatment of insomnia: a study involving network pharmacology and experimental validation. Front Pharmacol 2021; 12: 752211.
40. Han T, Jia Z, Zhang H, et al. Analysis of color regulation of fluoritum in Chinese pharmacopoeia based on the coloration mechanism of fluorite. Zhong Guo Zhong Yao Za Zhi 2016; 41: 4469-73.
41. Gao X, Liu Y, An Z, Ni J. Active components and pharmacological effects of Cornus Officinalis: literature review. Front Pharmacol 2021; 12: 633447.
42. Lyu JL, Bai Y, Lv YE, et al. Integrated colon microbiome and metabolomics to elucidate the antidepressant mechanisms of the Radix Bupleuri-Radix Paeoniae Alba herb pair. Metab Brain Dis 2024; 28; 40-45.
43. Zhang S, Zhou HF, Liu YN, et al. Study on Modified Dihuang decoction regulating Bcl-2-related mitochondrial apoptosis signal pathway to improve mouse ovarian reserve function. Zhong Guo Zhong Yao Za Zhi 2021; 46: 6493-501.
44. Jiang XF, Zhou HF, Shi M, et al. Bu-Shen-Zhu-Yun decoction promotes synthesis and secretion of FSHβ and LHβ in anterior pituitary cells in vitro. Biomed Pharmacother 2018; 102: 494-501.
45. Zhou HF, Li AP, Tan Y. Effect of Bushen Zhuyun recipe on the expression of ER, PR and integrin α5, β3 protein in rat endometrium during embryo implantation. Zhong Guo Jie He Yi Xue Za Zhi 2009; 29: 628-31.
46. Zhou HF, Jiang FG, Dun WL, Tan Y. Effect of Bushen Zhuyun recipe on morphology of endometrium and ovary during embryo implantation in rats. Shanxi Zhong Yi Yao Za Zhi 2009; 30: 117-8.
47. Karunyam BV, Abdul Karim AK, Naina Mohamed I, et al. Infertility and cortisol: a systematic review. Front Endocrinol (Lausanne) 2023; 14: 1147306.
Options
Outlines

/

〈 〉