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Open Access Study protocol

Acupuncture to improve live birth rates for women undergoing in vitro fertilization: a protocol for a randomized controlled trial

Caroline A Smith1*, Sheryl de Lacey2, Michael Chapman3, Julie Ratcliffe4, Robert J Norman5, Neil Johnson6, Gavin Sacks7, Jane Lyttleton8 and Clare Boothroyd9

Author Affiliations

1 Centre for Complementary Medicine Research, University of Western Sydney, Locked Bag, 1797, Penrith South, DC, NSW 2751, Australia

2 School of Nursing & Midwifery, Flinders University, GPO Box 2100, Adelaide, South Australia, 5001, Australia

3 School of Women’s and Children’s Health, University of New South Wales, St George Hospital, IVF Australia, Southern Sydney, South Street Kogarah, NSW 2217, Australia

4 Flinders Clinical Effectiveness, Flinders University, Bedford Park, South Australia, 5001, Australia

5 Robinson Institute, University of Adelaide, Norwich House, 55 King William Road, North Adelaide, South Australia, 5006, Australia

6 Fertility Plus, Auckland District Health Board; Repromed Auckland, University of Auckland, Auckland, New Zealand

7 School of Women’s and Children’s Health, University of New South Wales, St George Hospital, South Street, Kogarah, New South Wales, 2217, Australia

8 Paddington Medical Centre, 198 Oxford St, Paddington, New South Wales, 2021, Australia

9 Assisted Conception Australia, Greenslopes Private Hospital, Suite 9A, Administration Building, Brisbane, QLD, 4120, Australia

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Trials 2012, 13:60  doi:10.1186/1745-6215-13-60

Published: 18 May 2012

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).

Discussion

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.

Clinical Trial Registration

Australian and New Zealand Clinical Trial Registry ACTRN12611000226909