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

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  • Additional Information
    • Source:
      Publisher: BioMed Central Country of Publication: England NLM ID: 101263253 Publication Model: Electronic Cited Medium: Internet ISSN: 1745-6215 (Electronic) Linking ISSN: 17456215 NLM ISO Abbreviation: Trials Subsets: MEDLINE
    • Publication Information:
      Original Publication: [London] : BioMed Central, 2006-
    • Subject Terms:
      Acupuncture Therapy*/adverse effects ; Acupuncture Therapy*/economics ; Fertilization in Vitro*/adverse effects ; Fertilization in Vitro*/economics ; Live Birth* ; Research Design*; Infertility/*therapy; Abortion, Spontaneous/etiology ; Infertility/economics ; Infertility/psychology ; Adult ; Australia ; Combined Modality Therapy ; Embryo Transfer ; Female ; Health Care Costs ; Humans ; New Zealand ; Pregnancy ; Quality of Life ; Self Efficacy ; Sperm Injections, Intracytoplasmic ; Time Factors ; Treatment Outcome
    • 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.
    • Comments:
      Erratum in: Trials. 2017 Jun 1;18(1):248. doi: 10.1186/s13063-017-1986-4.. (PMID: 28571569)
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    • Publication Date:
      Date Created: 20120522 Date Completed: 20121106 Latest Revision: 20211021
    • Publication Date:
      20260130
    • Accession Number:
      PMC3464889
    • Accession Number:
      10.1186/1745-6215-13-60
    • Accession Number:
      22607192