Acupuncture in reproductive medicine: the motivations of infertile women to participate in a randomised controlled trial

Abstract

Introduction: 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.

Methods: 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.

Results: 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.

Conclusions: 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.

Keywords:

• Acupuncture
• infertility
• in vitro fertilisation
• randomised controlled trial
• reproductive medicine
• qualitative research

Acknowledgements

The RCT in which this study was nested is funded by a National Health and Medical Research Council (NHMRC) project grant: ID63905. The authors would like to acknowledge Sarah Fogarty and the research nurses and clinicians who have participated in the RCT recruitment. We would also like to acknowledge the generosity of the infertile women who participated in the interview.

Disclosure statement

The authors report no conflicts of interest.

Current knowledge on the subject

• Randomised clinical trials (RCTs) are rare in reproductive medicine (RM) despite the use of a variety of adjunct medical therapies, and few RCTs have taken place to study the efficacy of adjuvant acupuncture.

• No other studies exist that examine the motivations of infertile women for taking part in an RCT of adjuvant therapy whilst undergoing in vitro fertilisation.

What this study adds

• RCTs are the gold standard in medical research; therefore, it is important to understand what motivates women to participate in one. This study offers insight into the way infertile women in a reproductive medicine setting receive and process an invitation to participate in an RCT.

• Such insight will assist RM clinicians to decide whether to conduct an RCT and what factors are important in an ethical approach to recruitment and consent of infertile women.

Additional information

Funding

The RCT in which this study was nested is funded by a National Health and Medical Research Council (NHMRC) project grant: ID63905. The authors would like to acknowledge Sarah Fogarty and the research nurses and clinicians who have participated in the RCT recruitment.