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

Educational Objective
To learn about the efficacy of acupuncture for women undergoing in vitro fertilization (IVF).
1 Credit CME
Key Points

Question  Does acupuncture increase the likelihood of a live birth in women undergoing in vitro fertilization?

Findings  In this randomized clinical trial of 824 women, the rate of live births was 18.3% among women who received acupuncture vs 17.8% among women who received a sham acupuncture control, a nonsignificant difference.

Meaning  These findings do not support the use of acupuncture when administered at the time of ovarian stimulation and embryo transfer to improve the rate of live births.

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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Article Information

Corresponding Author: Caroline A. Smith, PhD, NICM Health Research Institute, Western Sydney University, Locked Bag 1797, Penrith, 2751, Australia (caroline.smith@westernsydney.edu.au).

Accepted for Publication: April 6, 2018.

Author Contributions: Dr Smith and Mr Fahey had full access to all of the data in the study and take responsibility for the integrity of the data and accuracy of the data analysis.

Concept and design: Smith, de Lacey, Chapman, Ratcliffe, Norman, Johnson, Boothroyd.

Acquisition, analysis, or interpretation of data: Smith, Chapman, Ratcliffe, Johnson, Boothroyd, Fahey.

Drafting of the manuscript: Smith, de Lacey, Chapman, Ratcliffe, Norman, Johnson.

Critical revision of the manuscript for important intellectual content: Smith, Chapman, Ratcliffe, Johnson, Boothroyd, Fahey.

Statistical analysis: Ratcliffe, Fahey.

Obtained funding: Smith, de Lacey, Chapman, Ratcliffe, Norman.

Administrative, technical, or material support: Smith, de Lacey, Ratcliffe, Boothroyd.

Supervision: Smith, Johnson, Boothroyd.

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.

Funding/Support: This study was funded by project grant APP 1003661 from the National Health and Medical Research Council of Australia. Acupuncture needles were donated by Helio Supply Co.

Role of the Funder/Sponsor: The funder had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.

Additional Contributions: We are grateful for all the women who consented to participate in the study. We thank the members of the data and safety monitoring committee who did not receive compensation: Peter Illingworth, MD (Hons), IVF Australia; William Ledger, MA, DPhil (Oxon), MB, ChB, University of New South Wales; and Chris Brown, MBiostat, National Health and Medical Research Council Clinical Trials Centre. We thank the following colleagues who were compensated for their role as clinical trial coordinators in the study: Sarah Fogarty, PhD, and Danielle Parker, BAppSci (TCM), NICM Health Research Institute, Western Sydney University. The following individuals contributed to recruitment and data collection at the sites: Gavin Sacks, DPhil, Sharne Rutherford, RN, RM, Stella Murphy, RN, Prue Sweeten, B Nursing, Mary O’Neil, RN, RM, IVF Australia; Manuela Toledo, MBBS, CREI, Franca Agresta, RN, Melbourne IVF; Howard Smith, PhD, Prue Fabrio, RN, Westmead Fertility; Gill Homan, RN, Mary Walkington, RN, Helen Newman, RN, Flinders Fertility; Martyn Stafford Bell, MBBS, Canberra Fertility; Paula Scanlon, RN, Fertility SA; Sandra Kennedy, Grad Cert RM, The Fertility Centre; Jane Campbell, RN, Fertility Plus; Sue Elliot, RN, Reproductive Medicine Albury; Rachael Harris, RN, Southern Clinical Trials; and Andrea Davidson, B Nursing, Fertility Associates. In vitro fertilization units were compensated. We thank all the participating acupuncturists for delivering the treatment interventions who were compensated for their contribution, in particular Mike Armour, PhD, Auckland; Janine Nana, BHS (Acupuncture), Wellington; Heather Barwick, BSc (Hons) (Acupuncture), Adelaide; Danielle Baker, BHS (Acupuncture), Melbourne; Farzaneh Ghaffari, BAppSc (ChinMed), Melbourne; Elissa Chapman, BAppSc (TCM), Canberra; Georgie Smith, MSc, Brisbane; Andrea Hart, BA, Adelaide; and Teresa Jezioranski Masters (TCM), Adelaide, for delivery of the interventions in Australia and New Zealand.

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