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Journal of Traditional Chinese Medicine ›› 2017, Vol. 37 ›› Issue (04): 530-537.

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Heyan Kuntai capsule versus dehydroepiandrosterone in treating Chinese patients with infertility caused by diminished ovarian reserve: a multicenter, randomized controlled trial

Gao Hui, Xia Tian, Ma Ruihong, Zhao Zhimei, Song Xueru, Wang Baojuan, Liu Lijing, Han Kaimei, Wang Guoqing, Fu Yu, Hao Guimin   

  1. Department of Traditional Chinese Medicine, Affiliated Hospital of Chengde Medical College;Department of Reproductive Center, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine;Department of Reproductive center, Tianjin Medical University General Hospital;Graduate School,Tianjin University of Traditional Chinese Medicine;Department of Acupuncture, First Teaching Hospital of Tianjin University of TCM;Department of Reproductive Center, The Second Hospital of Hebei Medical University;
  • Accepted:2017-08-15 Online:2017-08-15 Published:2022-04-04
  • Supported by:
    Supported by The Scientific research project of Administration of Traditional Chinese Medicine of Hebei Province:The Clinical Study of Kuntai Capsule in the Treatment of Infertility Women with Diminished Ovarian Reserve Diagnosed Liver-kidney Yin Deficiency and Heart-kidney Imbalance Syndrome(No.2016068)

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Abstract: OBJECTIVE: To evaluate the clinical efficacy and safety of Heyan Kuntai capsule(HYKT) in treating women with infertility caused by diminished ovarian reserve(DOR).METHODS: One hundred eight eligible patientsfrom three Chinese hospitals were randomly divided into an HYKT treatment group(n = 55) or a dehydroepiandrosterone(DHEA) treatment group(n =53). Patients in the HYKT group were treated orally with four 0.5 g HYKT three times a day; patients in the DHEA group were treated with one 25.0 mg DHEA capsule three times a day. All patients were treated for 3 months and followed up over a3-month period.RESULTS: Of 108 patients, 12 dropped out: six from the HYKT group, and six from the DHEA group. Eleven patients got pregnant during the treatment. Serum anti-Müllerian hormone levels and antral follicle counts increased significantly in both groups after treatment(P < 0.05) especially in the HYKT group(P < 0.05). Serum follicle stimulating hormone(FSH) levels and FSH/luteinizing hormone ratios decreased(P < 0.05) with no significant difference between the two groups. Estradiol levels in the HYKT group and DHEA-sulfate levels in the DHEA group both increased(P < 0.05). The spontaneous pregnancy rates were 12% and 11% in the HYKT and DHEA groups, respectively(not significant). During the follow-up period, 16 patients in the HYKT group underwent in vitro fertilization-embryo transfer(IVF-ET) and the number of retrieved oocytes was(5.1 ± 1.8). In DHEA group, 20 patients underwent IVF-ET and the number of retrieved oocyte was(4.2 ± 1.9)(not significant); clinical pregnancy rates were 38% in the HYKT group and 20%in DHEA group(not significant). No significant adverse reactions were observed.CONCLUSION: HYKT can improve the ovarian re-serve and hormone levels in patients with infertility caused by DOR. Pregnancy rates after HYKT treatment were similar to those of DHEA treatment.HYKT might be an alternative to the treatment of infertility caused by DOR.

Key words: Infertility,female, Ovarian reserve, Hormones, Dehydroepiandrosterone, Heyan Kuntaicapsule, Randomized controlled trial

Cite this article

Gao Hui, Xia Tian, Ma Ruihong, Zhao Zhimei, Song Xueru, Wang Baojuan, Liu Lijing, Han Kaimei, Wang Guoqing, Fu Yu, Hao Guimin. Heyan Kuntai capsule versus dehydroepiandrosterone in treating Chinese patients with infertility caused by diminished ovarian reserve: a multicenter, randomized controlled trial[J]. Journal of Traditional Chinese Medicine, 2017, 37(04): 530-537.