title: Acupuncture in reproductive medicine: the motivations of infertile women to participate in a randomised controlled trial.
abstract: Randomised controlled trials are the gold standard in medical research and are challenging to conduct successfully since high numbers of participants are needed to produce robust results. Therefore, it is important to understand what motivates patients to participate in one, particularly in Reproductive Medicine where the conduct of RCTs is rare. Just as it is important to evaluate medical interventions, it is equally important that adjuvant therapies are properly assessed. There has been an increased interest in adding acupuncture to in vitro fertilisation (IVF) in the hope of increasing the chance of pregnancy and a live birth. However, evidence that acupuncture assists IVF outcomes is conflicted and insight into the experiences and motivations of infertile women is important. This paper describes how an invitation to participate in an RCT of acupuncture as an adjuvant to IVF was received by infertile women and how they processed their decision to participate.
  
  
  
  In-depth interviews were conducted with 50 infertile women recruited from the RCT sample cohort. Recruitment aimed for maximum variation in social demographics. The data were saturated. Data pertaining to the theme of motivations to participate in an RCT were subjected to semantic thematic analysis.
  
  
  
  Two subthemes contained categories related to (a) the reasons women put forward for participation in an RCT, and (b) the rationale that underpinned and surrounded their decision. Women described themselves as active agents searching for a better outcome for their infertility or improved outcomes for women in the future. Their decision to participate in an RCT was motivated by factors such as opportunity, novelty and a value of science and was made after weighing various risks and benefits.
  
  
  
  The decision to participate in an RCT was an informed one. Infertile women in a stressful treatment situation participated in an RCT in the hope of finding a therapy to improve IVF outcomes for themselves and for other infertile women.
authors.affiliation: a School of Nursing and Midwifery, Flinders University , Adelaide , Australia.
authors.forename: Sheryl L
authors.identifier: 0000-0002-5652-9451
authors.initials: SL
authors.lastname: de Lacey
authors.affiliation: a School of Nursing and Midwifery, Flinders University , Adelaide , Australia.
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Sanderman
authors.affiliation: b National Institute of Complementary Medicine, Western Sydney University , Penrith , Sydney , Australia.
authors.forename: Caroline A
authors.initials: CA
authors.lastname: Smith
mesh_terms: D015670:Acupuncture Therapy / Q000379:methods*; D000328:Adult; D003131:Combined Modality Therapy; D005260:Female; D005307:Fertilization in Vitro / Q000379:methods*; D006801:Humans; D007246:Infertility / Q000628:therapy*; D010342:Patient Acceptance of Health Care; D010358:Patient Participation; D036301:Qualitative Research; D016032:Randomized Controlled Trials as Topic; D018456:Reproductive Medicine / Q000379:methods*
keywords: Acupuncture; in vitro fertilisation; infertility; qualitative research; randomised controlled trial; reproductive medicine