| Title | A multicenter randomized trial of personalized acupuncture, fixed acupuncture, letrozole, and placebo letrozole on live birth in infertile women with polycystic ovary syndrome |
| Authors | Huang, Shiya Hu, Min Ng, Ernest Hung Yu Stener-Victorin, Elisabet Zheng, Yanhua Wen, Qidan Wang, Cong Lai, Maohua Li, Juan Gao, Xingcheng Wang, Xinhua Hu, Zhenxing Xia, Tian Hu, Rongkui Liu, Jianping Wen, Xiaohui Li, Shuna Quan, Kewei Liang, Xingyan Shang, Hongcai Ma, Hongxia Qiao, Jie |
| Affiliation | Guangzhou Med Univ, Dept Tradit Chinese Med, Affiliated Hosp 1, Guangzhou, Guangdong, Peoples R China Guangzhou Med Univ, Inst Integrat Tradit Chinese Med & Western Med, Guangzhou, Guangdong, Peoples R China Univ Hong Kong, Dept Obstet & Gynecol, Hong Kong, Peoples R China Karolinska Inst, Dept Physiol & Pharmacol, Stockholm, Sweden Guangzhou Med Univ, Dept Tradit Chinese Med, Affiliated Hosp 2, Guangzhou, Guangdong, Peoples R China Guangdong Prov Hosp Tradit Chinese Med, Dept Tradit Therapy, Guangzhou, Guangdong, Peoples R China Guangzhou Med Univ, Dept Urol, Affiliated Hosp 1, Guangzhou, Guangdong, Peoples R China Xuzhou Matern & Child Hlth Care Hosp, Dept Gynecol, Xuzhou, Jiangsu, Peoples R China Tianjin Univ Tradit Chinese Med, Ctr Reprod Med, Teaching Hosp 1, Tianjin, Peoples R China Nanjing Univ Chinese Med, Dept Reprod Med, Affiliated Hosp, Nanjing, Jiangsu, Peoples R China Beijing Univ Chinese Med, Ctr Evidence Based Chinese Med, Beijing, Peoples R China Dongguan Hosp Tradit Chinese Med, Dept Obstet & Gynecol, Dongguan, Guangdong, Peoples R China Beijing Univ Chinese Med, Minist Educ, Key Lab Chinese Internal Med, Beijing, Peoples R China Beijing Univ Chinese Med, Dongzhimen Hosp, Beijing, Peoples R China Peking Univ, Hosp 3, Dept Obstet & Gynecol, Beijing, Peoples R China |
| Keywords | CHINESE WOMEN MANAGEMENT CLOMIPHENE CONSENSUS OVULATION |
| Issue Date | 4-Mar-2020 |
| Publisher | TRIALS |
| Abstract | Background Traditional Chinese medicine (TCM) usually involves syndrome differentiation and treatment. Acupuncture, one form of TCM, requires the selection of appropriate acupoints and needling techniques, but many clinical trials on acupuncture have used fixed acupuncture protocols without accounting for individual patient differences. We have designed a multicenter randomized controlled trial (RCT) to evaluate whether personalized or fixed acupuncture increases the likelihood of live births in infertile women with polycystic ovary syndrome (PCOS) compared with letrozole or placebo letrozole. We hypothesize that letrozole is more effective than personalized acupuncture, which in turn is more effective than fixed acupuncture, and that placebo letrozole is the least effective intervention. Moreover, we hypothesize that personalized acupuncture is more likely to reduce the miscarriage rate and the risk of pregnancy complications compared with letrozole. Methods/design The study is designed as an assessor-blinded RCT. A total of 1100 infertile women with PCOS will be recruited from 28 hospitals and randomly allocated to 4 groups: personalized acupuncture, fixed acupuncture, letrozole, or placebo letrozole. They will receive treatment for 16 weeks, and the primary outcome is live birth. Secondary outcomes include ovulation rate, conception rate, pregnancy rate, pregnancy loss rate, changes in hormonal and metabolic parameters, and changes in quality of life scores. Adverse events will be recorded throughout the trial. All statistical analyses will be performed using IBM SPSS Statistics version 21.0 software (IBM Corp., Armonk, NY, USA), and a P value < 0.05 will be considered statistically significant. Discussion This study will be the first multicenter RCT to compare the effect of personalized or fixed acupuncture with letrozole or placebo letrozole on live birth in infertile women with PCOS. The findings will inform whether personalized acupuncture therapy can be considered an alternative treatment to improve the live birth rate in infertile women with PCOS. |
| URI | http://hdl.handle.net/20.500.11897/587069 |
| DOI | 10.1186/s13063-020-4154-1 |
| Indexed | SCI(E) Scopus |
| Appears in Collections: | 第三医院 |
