title: Acupuncture to improve live birth rates for women undergoing in vitro fertilization: a protocol for a randomized controlled trial.
abstract: BACKGROUND
  IVF is a costly treatment option for women, their partners, and the public. Therefore new therapies that improve reproductive and health outcomes are highly desirable. There is a growing body of research evaluating the effect of acupuncture administered during IVF, and specifically on the day of embryo transfer (ET). Many trials are heterogeneous and results inconsistent. There remains insufficient evidence to determine if acupuncture can enhance live birth rates when used as an adjunct to IVF treatment.The study will determine the clinical effectiveness of acupuncture with improving the proportion of women undergoing IVF having live births. Other objectives include: determination of the cost effectiveness of IVF with acupuncture; and examination of the personal and social context of acupuncture in IVF patients, and examining the reasons why the acupuncture may or may not have worked.
  
  
  METHODS
  We will conduct a randomized controlled trial of acupuncture compared to placebo acupuncture.Inclusion criteria include: women aged less than 43 years; undergoing a fresh IVF or ICSI cycle; and restricted to women with the potential for a lower live birth rate defined as two or more previous unsuccessful ETs; and unsuccessful clinical pregnancies of quality embryos deemed by the embryologist to have been suitable for freezing by standard criteria. Women will be randomized to acupuncture or placebo acupuncture. Treatment is administered on days 6 to 8 of the stimulated cycle and two treatments on the day of ET. A non-randomized cohort of women not using acupuncture will be recruited to the study. The primary study outcome is the proportion of women reporting a live birth. Secondary outcomes include the proportion of women reporting a clinical pregnancy miscarriage prior to 12 weeks, quality of life, and self-efficacy. The sample size of the study is 1,168 women, with the aim of detecting a 7% difference in live births between groups (P = 0.05, 80% power).
  
  
  CONCLUSIONS
  There remains a need for further research to add significant new knowledge to defining the exact role of certain acupuncture protocols in the management of infertility requiring IVF from a clinical and cost-effectiveness perspective.
  
  
  BACKGROUND
  Australian and New Zealand Clinical Trial Registry ACTRN12611000226909.
authors.affiliation: Centre for Complementary Medicine Research, University of Western Sydney, Locked Bag, 1797, Penrith South, DC, NSW 2751, Australia. caroline.smith@uws.edu.au
authors.forename: Caroline A
authors.initials: CA
authors.lastname: Smith
authors.forename: Sheryl
authors.initials: S
authors.lastname: de Lacey
authors.forename: Michael
authors.initials: M
authors.lastname: Chapman
authors.forename: Julie
authors.initials: J
authors.lastname: Ratcliffe
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Norman
authors.forename: Neil
authors.initials: N
authors.lastname: Johnson
authors.forename: Gavin
authors.initials: G
authors.lastname: Sacks
authors.forename: Jane
authors.initials: J
authors.lastname: Lyttleton
authors.forename: Clare
authors.initials: C
authors.lastname: Boothroyd
mesh_terms: D000022:Abortion, Spontaneous / Q000209:etiology; D015670:Acupuncture Therapy / Q000009:adverse effects / Q000191:economics; D000328:Adult; D001315:Australia; D003131:Combined Modality Therapy; D004624:Embryo Transfer; D005260:Female; D005307:Fertilization in Vitro / Q000009:adverse effects / Q000191:economics; D017048:Health Care Costs; D006801:Humans; D007246:Infertility / Q000191:economics / Q000523:psychology / Q000628:therapy*; D050498:Live Birth; D009520:New Zealand; D011247:Pregnancy; D011788:Quality of Life; D012107:Research Design; D020377:Self Efficacy; D020554:Sperm Injections, Intracytoplasmic; D013997:Time Factors; D016896:Treatment Outcome