Centre for Complementary Medicine Research, University of Western Sydney, Locked Bag, 1797, Penrith South, DC, NSW 2751, Australia.
Trials. 2012 May 18;13:60. doi: 10.1186/1745-6215-13-60.
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.
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).
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.
Australian and New Zealand Clinical Trial Registry ACTRN12611000226909.
体外受精（IVF）是一种昂贵的治疗选择，无论是对女性、其伴侣还是公众而言。因此，人们非常希望有新的治疗方法能够改善生殖和健康结果。目前有越来越多的研究评估了在 IVF 期间进行针灸的效果，特别是在胚胎移植（ET）当天。许多试验存在异质性，结果不一致。仍然没有足够的证据来确定针灸是否可以提高作为 IVF 治疗辅助手段的活产率。本研究将确定针灸在提高 IVF 患者活产率方面的临床效果。其他目标包括：确定 IVF 加用针灸的成本效益；以及检查 IVF 患者针灸的个人和社会背景，并研究针灸可能有效或无效的原因。
我们将进行一项随机对照试验，比较针灸与安慰剂针灸。纳入标准包括：年龄小于 43 岁的女性；接受新鲜 IVF 或 ICSI 周期；以及限制为具有较低活产率潜力的女性，定义为两次或两次以上先前 ET 失败；以及胚胎学家认为适合通过标准标准冷冻的优质胚胎的不成功临床妊娠。女性将被随机分配到针灸或安慰剂针灸组。治疗在刺激周期的第 6 至 8 天进行，并在 ET 当天进行两次治疗。未使用针灸的女性将被招募到研究的非随机队列中。主要研究结果是报告活产的女性比例。次要结果包括报告 12 周前临床妊娠流产的女性比例、生活质量和自我效能。该研究的样本量为 1168 名女性，旨在检测组间活产率差异 7%（P=0.05，80%效力）。
从临床和成本效益的角度来看，仍需要进一步研究来增加关于特定针灸方案在需要 IVF 的不孕症管理中的确切作用的新的重要知识。
澳大利亚和新西兰临床试验注册 ACTRN12611000226909。
