title: Comparison of acupuncture pretreatment followed by letrozole versus letrozole alone on live birth in anovulatory infertile women with polycystic ovary syndrome: a study protocol for a randomised controlled trial.
abstract: The high prevalence of insulin resistance in women with polycystic ovary syndrome (PCOS) is considered to be one of the major pathophysiological changes in PCOS that leads to anovulatory infertility. We hypothesise that electroacupuncture pretreatment improves insulin sensitivity and leads to a higher ovulation rate and greater chances of live birth after the induction of ovulation. The effect of electroacupuncture pretreatment followed by ovulation induction in women with anovulatory PCOS has not been investigated before, and we present here a randomised controlled trial to test this hypothesis by comparing electroacupuncture pretreatment followed by letrozole versus letrozole alone in anovulatory women with PCOS.
  
  
  
  This is a multicentre, randomised,and controlled trial. A total of 384 patients will be enrolled in this study and will be randomly allocated by a central randomisation system to the treatment group or the control group in a 1:1 ratio. The treatment group will undergo 16 weeks of electroacupuncture pretreatment followed by 4 cycles of letrozole, and the control group will only undergo 4 cycles of letrozole. The primary outcome will be the live birth rate. All statistical analyses will be performed using the SPSS program V.21.0 (SPSS, Chicago, Illinois, USA), and a p value <0.05 will be considered statistically significant.
  
  
  
  This study has been approved by the ethics committees of each participating centre. Written consent will be obtained from each patient and her husband before any study procedure is performed. Adverse events will be categorised, and the percentage of patients experiencing adverse events or serious adverse events during the treatment period will be documented. The results of this trial will be disseminated in peer-reviewed journals and presented at international meetings.
  
  
  
  NCT02491320.
authors.affiliation: Department of Traditional Chinese Medicine, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.
authors.forename: Juan
authors.initials: J
authors.lastname: Li
authors.affiliation: Department of Obstetrics and Gynecology, The University of Hong Kong, Hong Kong Special Administrative Region, Hong Kong, Hong Kong.
authors.forename: Ernest Hung Yu
authors.initials: EH
authors.lastname: Ng
authors.affiliation: Department of Physiology and Pharmacology, Karolinska Institutet, Stockholm, Sweden.
authors.forename: Elisabet
authors.initials: E
authors.lastname: Stener-Victorin
authors.affiliation: Department of Gynecology, Xuzhou Maternity and Child Health Hospital, Xuzhou, Jiangsu, China.
authors.forename: Zhenxing
authors.initials: Z
authors.lastname: Hu
authors.affiliation: Department of Traditional Chinese Medicine, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.
authors.forename: Wanting
authors.initials: W
authors.lastname: Wu
authors.affiliation: Department of Traditional Chinese Medicine, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.
authors.forename: Maohua
authors.initials: M
authors.lastname: Lai
authors.affiliation: Chinese Clinical Trial Registry, Beijing, China.
authors.forename: Taixiang
authors.initials: T
authors.lastname: Wu
authors.affiliation: Department of Traditional Chinese Medicine, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.
authors.forename: Hongxia
authors.initials: H
authors.lastname: Ma
mesh_terms: D015670:Acupuncture Therapy; D000328:Adult; D047072:Aromatase Inhibitors / Q000627:therapeutic use; D001723:Birth Rate; D002985:Clinical Protocols; D015671:Electroacupuncture; D005260:Female; D006801:Humans; D007247:Infertility, Female / Q000209:etiology / Q000628:therapy*; D007333:Insulin Resistance; D000077289:Letrozole; D050498:Live Birth; D009570:Nitriles / Q000627:therapeutic use*; D010060:Ovulation; D010062:Ovulation Induction; D011085:Polycystic Ovary Syndrome / Q000150:complications / Q000628:therapy*; D012107:Research Design; D014230:Triazoles / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D047072:Aromatase Inhibitors; D009570:Nitriles; D014230:Triazoles; D000077289:Letrozole
keywords: acupuncture pretreatment; letrozole; live birth rate; polycystic ovary syndrome