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Randomized Controlled Trial
. 2018 May 15;319(19):1990-1998.
doi: 10.1001/jama.2018.5336.

Effect of Acupuncture vs Sham Acupuncture on Live Births Among Women Undergoing In Vitro Fertilization: A Randomized Clinical Trial

Caroline A Smith  1 , Sheryl de Lacey  2 , Michael Chapman  3 , Julie Ratcliffe  4 , Robert J Norman  5 , Neil P Johnson  6   7 , Clare Boothroyd  8 , Paul Fahey  9
Affiliations
Randomized Controlled Trial

Effect of Acupuncture vs Sham Acupuncture on Live Births Among Women Undergoing In Vitro Fertilization: A Randomized Clinical Trial

Caroline A Smith et al. JAMA. .

Abstract

Importance: Acupuncture is widely used by women undergoing in vitro fertilization (IVF), although the evidence for efficacy is conflicting.

Objective: To determine the efficacy of acupuncture compared with a sham acupuncture control performed during IVF on live births.

Design, setting, and participants: A single-blind, parallel-group randomized clinical trial including 848 women undergoing a fresh IVF cycle was conducted at 16 IVF centers in Australia and New Zealand between June 29, 2011, and October 23, 2015, with 10 months of pregnancy follow-up until August 2016.

Interventions: Women received either acupuncture (n = 424) or a sham acupuncture control (n = 424). The first treatment was administered between days 6 to 8 of follicle stimulation, and 2 treatments were administered prior to and following embryo transfer. The sham control used a noninvasive needle placed away from the true acupuncture points.

Main outcomes and measures: The primary outcome was live birth, defined as the delivery of 1 or more living infants at greater than 20 weeks' gestation or birth weight of at least 400 g.

Results: Among 848 randomized women, 24 withdrew consent, 824 were included in the study (mean [SD] age, 35.4 [4.3] years); 371 [45.0%] had undergone more than 2 previous IVF cycles), 607 proceeded to an embryo transfer, and 809 (98.2%) had data available on live birth outcomes. Live births occurred among 74 of 405 women (18.3%) receiving acupuncture compared with 72 of 404 women (17.8%) receiving sham control (risk difference, 0.5% [95% CI, -4.9% to 5.8%]; relative risk, 1.02 [95% CI, 0.76 to 1.38]).

Conclusions and relevance: Among women undergoing IVF, administration of acupuncture vs sham acupuncture at the time of ovarian stimulation and embryo transfer resulted in no significant difference in live birth rates. These findings do not support the use of acupuncture to improve the rate of live births among women undergoing IVF.

Trial registration: anzctr.org.au Identifier: ACTRN12611000226909.

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Conflict of interest statement

Conflict of Interest Disclosures: All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest. Dr Smith reported collaborating with Jane Lyttleton, MPhil, a clinical director of the Acupuncture Pregnancy Clinic where some treatments were administered in this study (Ms Lyttleton did not receive compensation). Ms Lyttleton, in addition to other international experts, provided clinical advice to the design of the acupuncture treatment used in this study. As a medical research institute, the NICM Health Research Institute receives research grants and donations from foundations, universities, government agencies, and industry. Sponsors and donors provide untied and tied funding for work to advance the vision and mission of the institute. Dr Chapman reported he is a shareholder in an in vitro fertilization clinic. Dr Norman reported being a shareholder in a fertility company, Fertility SA. Dr Johnson reported receiving personal fees from Guerbet and Vifor Pharma; nonfinancial support from Bayer Pharma, Merck-Serono, and Merck Sharp & Dohme; and grants from AbbVie. Mr Fahey reported receiving grants from the National Health and Medical Research Council, Australia. No other disclosures were reported.

Figures

Figure.
Figure.. Flow of Participants Randomized to Acupuncture vs Sham Acupuncture
aReasons for which women did not meet inclusion criteria or did not attend study treatments are not available. bPostrandomization exclusions did not receive treatment because following randomization, they did not meet the eligibility criteria, ie, their type of treatment changed or they got pregnant naturally; therefore, there was no need for in vitro fertilization or acupuncture. However, some of their data were included in the sensitivity analysis. cPrimary analysis excludes women who withdrew consent for data to be used and those excluded postrandomization; included are the cases with live births.
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