Chinese Medicine Sequential Therapy Improves Pregnancy Outcomes after Surgery for Endometriosis-Associated Infertility: A Multicenter Randomized Double-blind Placebo Parallel Controlled Clinical Trial.
10.1007/s11655-019-3208-2
- Author:
Rui-Hua ZHAO
1
,
2
;
Yong LIU
3
;
Dan LU
4
;
Ying WU
4
;
Xiao-Yun WANG
5
;
Wei-Li LI
6
;
Cheng ZENG
7
;
Qing-Wei MENG
8
;
Feng-Mei LIAN
3
;
Jun ZHOU
6
;
Yun SHI
9
;
Wei-Wei SUN
3
;
Qian HAN
4
;
Yi TANG
10
;
Guang SHI
3
Author Information
1. Department of Gynecology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China. rhzh801@
2. com.
3. Department of Gynecology, Guang'anmen Hospital, China Academy of Chinese Medical Sciences, Beijing, 100053, China.
4. Department of Gynecology, Beijing Obstetrics and Gynecology Hospital, Capital Medical University, Beijing, 100026, China.
5. Department of Gynecology, Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou, 510120, China.
6. Department of Gynecology, First Affiliated Hospital of Anhui University of Traditional Chinese Medicine, Hefei, 230031, China.
7. Department of Gynecology, First Affiliated Hospital of Guangzhou University of Traditional Chinese Medicine, Guangzhou, 510405, China.
8. Department of Gynecology, Beijing Hospital, Beijing, 100730, China.
9. Department of Gynecology, Dongzhimen Hospital Beijing University of Chinese Medicine, Beijing, 100700, China.
10. Maternal and Child Health Service Center of Pidu District, Chengdu, 611730, China.
- Publication Type:Journal Article
- Keywords:
Bushen Zhuyun Granule;
Chinese medicine;
Huoxue Xiaoyi Granule;
endometriosis;
infertility;
pregnancy rate;
randomized controlled clinical trial
- From:
Chinese journal of integrative medicine
2020;26(2):92-99
- CountryChina
- Language:English
-
Abstract:
OBJECTIVE:To evaluate the efficacy and safety of Chinese medicine (CM) improving pregnancy outcomes after surgery for endometriosis-associated infertility.
METHODS:A multicenter, randomized, double-blind placebo parallel controlled clinical trial was designed. A total of 202 patients who had laparoscopy for endometriosis-associated infertility with qi stagnation and blood stasis syndrome were included and randomly divided into the CM treatment group and placebo control group at a ratio of 1:1 using a central block randomization from May 2014 to September 2017, 101 patients in each group. The two groups received continuous intervention at 1-5 days after surgery, for 6 menstrual cycles. Before ovulation, the CM group was treated Huoxue Xiaoyi Granule (); after ovulation, Bushen Zhuyun Granule ( was involved. The control group was treated with placebo. Transvaginal ultrasonography was performed every menstrual cycle during the treatment, and female hormone levels in the follicular and luteal phases were measured during the 1st, 3rd and 6th menstrual cycles. The analysis was continued until pregnancy. The primary outcomes were clinical pregnancy rate and pregnancy outcome, and the secondary outcomes were follicular development and endometrial receptivity. Safety evaluations were performed before and after treatment.
RESULTS:(1) Clinical pregnancy and live birth rates: the clinical pregnancy and live birth rates of the CM group were significantly higher than those of the placebo group [44.6% (45/101) vs. 29.7% (30/101), 34.7% (35/101) vs. 20.8% (21/101), both P<0.05]. (2) Follicle development: the incidence of dominant follicles, rate of cumulative cycle ovulation, and rate of cumulative cycle mature follicle ovulation were significantly higher in the CM group than those in the placebo group [93.8% (350/373) vs. 89.5% (341/381), 80.4% (275/342) vs. 69.1% (253/366), 65.8% (181/275) vs 56.1% (142/253), P<0.05 or P<0.01]). The incidence of cumulative cycle luteinized unruptured follicle syndrome was significantly lower in the CM group than in the placebo group [11.7% (40/342) vs. 17.8% (65/366), P<0.05). (3) Endometrial receptivity: after treatment, both endometrial types and endometrial blood flow types in the CM group were mainly types A and B, while those in the placebo group were mainly types B and C, with a significant difference between the two groups (both P<0.05). (4) Adverse events: the incidence of adverse events between the two groups was not significantly different (P>0.05).
CONCLUSION:Strategies for activating blood circulation-regulating Gan (Liver)-tonifying Shen (Kidney) sequential therapy can effectively improve the clinical pregnancy rate and live birth rate of endometriosis-associated infertility with qi stagnation and blood stasis after laparoscopy, improve follicular development, promote ovulation, improve endometrial receptivity, while being a safe treatment option. (Trial registration No. NCT02676713).
