A multicenter randomized trial of personalized acupuncture, fixed acupuncture, letrozole, and placebo letrozole on live birth in infertile women with polycystic ovary syndrome
Shiya Huang,
Min Hu,
Ernest Hung Yu Ng,
Elisabet Stener-Victorin,
Yanhua Zheng,
Qidan Wen,
Cong Wang,
Maohua Lai,
Juan Li,
Xingcheng Gao,
Xinhua Wang,
Zhenxing Hu,
Tian Xia,
Rongkui Hu,
Jianping Liu,
Xiaohui Wen,
Shuna Li,
Kewei Quan,
Xingyan Liang,
Hongcai Shang,
Hongxia Ma,
Jie Qiao
Affiliations
Shiya Huang
Department of Traditional Chinese Medicine, First Affiliated Hospital of Guangzhou Medical University
Min Hu
Department of Traditional Chinese Medicine, First Affiliated Hospital of Guangzhou Medical University
Ernest Hung Yu Ng
Department of Obstetrics and Gynecology, University of Hong Kong
Elisabet Stener-Victorin
Institute of Integration of Traditional Chinese Medicine and Western Medicine, Guangzhou Medical University
Yanhua Zheng
Department of Traditional Chinese Medicine, Second Affiliated Hospital of Guangzhou Medical University
Qidan Wen
Department of Traditional Chinese Medicine, First Affiliated Hospital of Guangzhou Medical University
Cong Wang
Department of Traditional Therapy, Guangdong Provincial Hospital of Traditional Chinese Medicine
Maohua Lai
Department of Traditional Chinese Medicine, First Affiliated Hospital of Guangzhou Medical University
Juan Li
Department of Traditional Chinese Medicine, First Affiliated Hospital of Guangzhou Medical University
Xingcheng Gao
Department of Urology, First Affiliated Hospital of Guangzhou Medical University
Xinhua Wang
Department of Traditional Chinese Medicine, First Affiliated Hospital of Guangzhou Medical University
Zhenxing Hu
Department of Gynecology, Xuzhou Maternity and Child Health Care Hospital
Tian Xia
Center for Reproductive Medicine, First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Rongkui Hu
Department of Reproductive Medicine, Affiliated Hospital of Nanjing University of Chinese Medicine
Jianping Liu
Institute of Integration of Traditional Chinese Medicine and Western Medicine, Guangzhou Medical University
Xiaohui Wen
Department of Traditional Chinese Medicine, First Affiliated Hospital of Guangzhou Medical University
Shuna Li
Department of Traditional Chinese Medicine, First Affiliated Hospital of Guangzhou Medical University
Kewei Quan
Department of Obstetrics and Gynecology, Dongguan Hospital of Traditional Chinese Medicine
Xingyan Liang
Department of Traditional Chinese Medicine, First Affiliated Hospital of Guangzhou Medical University
Hongcai Shang
Institute of Integration of Traditional Chinese Medicine and Western Medicine, Guangzhou Medical University
Hongxia Ma
Department of Traditional Chinese Medicine, First Affiliated Hospital of Guangzhou Medical University
Jie Qiao
Department of Obstetrics and Gynecology, Third Hospital, Peking University
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. Trial registration ClinicalTrials.gov, NCT03625531. Registered on July 13, 2018. Chinese Clinical Trial Registry, ChiCTR1800017304. Registered on July 23, 2018.