Efficacy of Yushen Tongluo Granule Combined with Clomiphene Citrate for Anovulatory Infertility: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial

Huayun Xu; Songpo Wang; Xiaohong Gao; Guozeng Wang

doi:10.1155/2022/7933611

Efficacy of Yushen Tongluo Granule Combined with Clomiphene Citrate for Anovulatory Infertility: A Double-Blind, Randomized, Placebo-Controlled Clinical Trial

Evid Based Complement Alternat Med. 2022 Jan 27:2022:7933611. doi: 10.1155/2022/7933611. eCollection 2022.

Authors

Huayun Xu¹, Songpo Wang¹, Xiaohong Gao², Guozeng Wang³

Affiliations

¹ Department of Traditional Chinese Medicine, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200080, China.
² Department of Obstetrics and Gynecology, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200080, China.
³ Department of Obstetrics and Gynecology, Shanghai East Hospital, Tongji University School of Medicine, Shanghai 200120, China.

Abstract

Objective: To evaluate the efficacy and safety of Yushen Tongluo Granule (YSTLG) combined with clomiphene citrate (CC) in the treatment of anovulatory infertility.

Methods: This randomized, double-blinded, placebo-controlled clinical trial was carried out in the Department of Obstetrics and Gynecology and the Department of Traditional Chinese Medicine (TCM). During the 3 menstrual cycle intervention periods, all subjects received 50 mg/day CC from day 5 until day 9 of the menstruation. If no ovulation, the amount of CC per cycle increased 50 mg/day until 150 mg/day. Participants in the experimental group received YSTLG, while participants in the control group received YSTLG placebo. The granules were orally taken from the end of menstruation until ovulation. When one leading follicle attained a diameter of 18 mm or more, 5000 U human chorionic gonadotropin (hCG) was given intramuscularly. The primary outcome measure was the ovulation rate, and follicular development was monitored by transvaginal ultrasound on the 10^th day of the cycles until ovulation. Secondary outcome measures including the overall curative effect, endometrial thickness, and pregnancy outcomes were also compared between the two groups.

Results: The ovulation rate in the experimental group was higher than that in the control group (P < 0.05). Compared with the control group, the overall curative effect of the experimental group was better than that of the control group (P < 0.05), and the endometrial thickness in the ovulation phase was significantly thicker than that in the control group (P < 0.01). There was no significant difference in pregnancy rate and miscarriage rate between the experimental group and control group (P > 0.05).

Conclusion: The combined YSTLG and CC used to treat anovulatory infertility can improve the ovulation rate without affecting endometrial thickness, which is efficacious and safe.