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Effects of a Delphi consensus acupuncture treatment protocol on the levels of stress and vascular tone in women undergoing in-vitro fertilization: a randomized clinical trial protocol.

ABSTRACT: The variability of published acupuncture protocols for patients undergoing In-Vitro Fertilization (IVF) complicates the interpretation of data and hinders our understanding of acupuncture's impact. In 2012, an acupuncture treatment protocol developed by a Delphi consensus process was published to describe the parameters of best practice acupuncture for Assisted Reproductive Technology and future research. However, there has been no clinical trial utilizing this protocol to assess the effects of acupuncture. This study aims to ?a?sse?ss the implementation of Dephi consensus acupuncture protocol and to examine the impact of acupuncture on stress and uterine and ovarian blood flow among women between ages 21-42 years seeking IVF.This study is a one site prospective, two-arm randomized controlled non-blind clinical trial conducted in a medical school-affiliated fertility center . Participants will be randomized 1:1 into either the acupuncture group or the standard of care (no acupuncture) group using computer generated tables. Both groups will have 3 regular clinical visits as their standard IVF care during an approximately 2 to 3 weeks window. Women who are randomized into the acupuncture group would receive three sessions based on the Delphi consensus acupuncture protocol in addition to the standard care. The first treatment will be administered between days 6 to 8 of the stimulated IVF cycle. The second session will be performed on the day of embryo transfer at least 1 h prior to the transfer. The third session will be performed within 48 h post-embryo transfer. Participants will be followed for their pregnancy test and pregnancy outcome when applicable. The outcomes stress and blood flow will be measured by a validated perceived stress scale and vasoactive molecules, respectively.Although recruitment and scheduling could be challenging at times, the Delphi consensus acupuncture protocol was implemented as planned and well-accepted by the patients. Because of the time-specified sessions around patients' IVF cycle, it is highly recommended to have on-site study acupuncturist(s) to accommodate the schedule.ClinicalTrials NCT02591186 registered on October 7, 2015.

SUBMITTER: Zhang Y

PROVIDER: S-EPMC5381072 | biostudies-literature | 2017 Apr

REPOSITORIES: biostudies-literature

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Effects of a Delphi consensus acupuncture treatment protocol on the levels of stress and vascular tone in women undergoing in-vitro fertilization: a randomized clinical trial protocol.

Zhang Yan Y Phy Jennifer J Scott-Johnson Chris C Garos Sheila S Orlando Jennie J Prien Samuel S Huang Jaou-Chen JC

BMC complementary and alternative medicine 20170404 1

<h4>Background</h4>The variability of published acupuncture protocols for patients undergoing In-Vitro Fertilization (IVF) complicates the interpretation of data and hinders our understanding of acupuncture's impact. In 2012, an acupuncture treatment protocol developed by a Delphi consensus process was published to describe the parameters of best practice acupuncture for Assisted Reproductive Technology and future research. However, there has been no clinical trial utilizing this protocol to ass ...[more]

PMID: 28376836

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Project description:BackgroundAssisted reproductive technologies (ART) are increasingly utilised for resolving difficulties conceiving. These technologies are expensive to both the public purse and the individual consumers. Acupuncture is widely used as an adjunct to ART with indications that it may assist reducing the time to conception and increasing live birth rates. Heterogeneity is high between treatment protocols. The aim of this study was to examine what fertility acupuncturists consider key components of best practice acupuncture during an ART cycle, and to establish an acupuncture protocol by consensus.MethodsFifteen international acupuncturists with extensive experience treating women during ART interventions participated in 3 rounds of Delphi questionnaires. The first round focused on identifying the parameters of acupuncture treatment as adjunct to ART, the second round evaluated statements derived from the earlier round, and the third evaluated specific parameters for a proposed trial protocol. Consensus was defined as greater than 80% agreement.ResultsSignificant agreement was achieved on the parameters of best practice acupuncture, including an acupuncture protocol suitable for future research. Study participants confirmed the importance of needling aspects relating to the dose of acupuncture, the therapeutic relationship, tailoring treatment to the individual, and the role of co-interventions. From two rounds of the Delphi a consensus was achieved on seven treatment parameters for the design of the acupuncture treatment to be used in a clinical trial of acupuncture as an adjunct to ART. The treatment protocol includes the use of the traditional Chinese medicine acupuncture, use of manual acupuncture, a first treatment administered between day 6-8 of the stimulated ART cycle which is individualised to the participant, two treatments will be administered on the day of embryo transfer, and will include points SP8, SP10, LR3, ST29, CV4, and post transfer include: GV20, KD3, ST36, SP6, and PC6. Auricular points Shenmen and Zigong will be used. Practitioner intent or yi will be addressed in the treatment protocol.ConclusionsDespite a lack of homogeneity in the research and clinical literature on ART and acupuncture, a consensus amongst experts on key components of a best practice treatment protocol was possible. Such consensus offers guidance for further research.

Project description: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.

Project description:Background: Currently, more and more subfertility couples are opting for combined acupuncture to improve the success rate of in vitro fertilization and embryo transfer (IVF-ET). However, the efficacy and safety of acupuncture in IVF-ET is still highly controversial. Objectives: The purpose of this overview is to summarize evidence of essential outcomes of systematic reviews (SRs) of acupuncture in IVF-ET and evaluate their methodological quality. Methods: We conducted a comprehensive literature search for relevant SRs in eight databases from inception to July 31, 2020, without language restriction. We evaluated the methodological quality of the included SRs by using A Measurement Tool to Assess Systematic Reviews 2 (AMSTAR-2), which was the latest available assessment tool. The Risk of Bias in Systematic Review (ROBIS) tool was used to assess the risk of bias in SRs. We assessed the Grades of Recommendation, Assessment, Development, and Evaluation (GRADE) score to determine the strength of evidence. We excluded the overlapping randomized controlled trials (RCTs) and performed a re-meta-analysis of the primary RCTs. Results: This review included 312 original RCT studies and 65,388 participants. By using AMSTAR-2, we found that the methodological quality of 16 SRs was critically low, because they had more than one critical weakness. Our reviews showed that although the GRADE for quality of evidence profile was suboptimal, acupuncture seemed to be beneficial in increasing the pregnancy rate. Our re-meta-analysis suggested that acupuncture was superior to sham acupuncture in improving the clinical pregnancy rate (CPR) of IVF-ET with substantial heterogeneity (RR = 1.31, 95% CI: 1.13-1.52, p = 0.0004, I 2 = 66%). No statistical difference was observed regarding the outcomes of live birth rate (LBR), ongoing pregnancy rate (OPR), biochemical pregnancy rate (BPR), and miscarriage rate (MR) between two groups. When compared with no adjunctive treatment groups, acupuncture improved CPR (RR = 1. 25, 95% CI: 1.11-1.42, p = 0.0003) and OPR (RR = 1. 38, 95% CI: 1.04-1.83, p = 0.03). Acupuncture was more superior than no adjunctive treatment in reducing MR (OR = 1.42, 95% CI: 1.03-1.95, p = 0.03) and BPR (RR = 1.19, 95% CI: 1.02-1.37, p = 0.02). Conclusions: Although the evidence of acupuncture in IVF-ET is insufficient, acupuncture appears to be beneficial to increase the clinical pregnancy rate in women undergoing IVF-ET. However, there are severe heterogeneity and methodological quality defects, which limit the reliability of results. Further, high-quality primary studies are still needed.

Project description:BACKGROUND Recent systematic reviews of adjuvant acupuncture for IVF have pooled heterogeneous trials, without examining variables that might explain the heterogeneity. The aims of our meta-analysis were to quantify the overall pooled effects of adjuvant acupuncture on IVF clinical pregnancy success rates, and evaluate whether study design-, treatment- and population-related factors influence effect estimates. METHODS We included randomized controlled trials that compared needle acupuncture administered within 1 day of embryo transfer, versus sham acupuncture or no adjuvant treatment. Our primary outcome was clinical pregnancy rates. We obtained from all investigators additional methodological details and outcome data not included in their original publications. We analysed sham-controlled and no adjuvant treatment-controlled trials separately, but since there were no large or significant differences between these two subsets, we pooled all trials for subgroup analyses. We prespecified 11 subgroup variables (5 clinical and 6 methodological) to investigate sources of heterogeneity, using single covariate meta-regressions. RESULTS Sixteen trials (4021 participants) were included in the meta-analyses. There was no statistically significant difference between acupuncture and controls when combining all trials [risk ratio (RR) 1.12, 95% confidence interval (CI), 0.96-1.31; I(2) = 68%; 16 trials; 4021 participants], or when restricting to sham-controlled (RR 1.02, 0.83-1.26; I(2) = 66%; 7 trials; 2044 participants) or no adjuvant treatment-controlled trials (RR 1.22, 0.97-1.52; I(2) = 67%; 9 trials; 1977 participants). The type of control used did not significantly explain the statistical heterogeneity (interaction P = 0.27). Baseline pregnancy rate, measured as the observed rate of clinical pregnancy in the control group of each trial, was a statistically significant effect modifier (interaction P < 0.001), and this covariate explained most of the heterogeneity of the effects of adjuvant acupuncture across all trials (adjusted R(2) = 93%; I(2) residual = 9%). Trials with lower control group rates of clinical pregnancy showed larger effects of adjuvant acupuncture (RR 1.53, 1.28-1.84; 7 trials; 1732 participants) than trials with higher control group rates of clinical pregnancy (RR 0.90, 0.80-1.01; 9 trials; 2289 participants). The asymmetric funnel plot showed a tendency for the intervention effects to be more beneficial in smaller trials. CONCLUSIONS We found no pooled benefit of adjuvant acupuncture for IVF. The subgroup finding of a benefit in trials with lower, but not higher, baseline pregnancy rates (the only statistically significant subgroup finding in our earlier review) has been confirmed in this update, and was not explained by any confounding variables evaluated. However, this baseline pregnancy rate subgroup finding among published trials requires further confirmation and exploration in additional studies because of the multiple subgroup tests conducted, the risk of unidentified confounders, the multiple different factors that determine baseline rates, and the possibility of publication bias.

Project description:Introduction: Growing evidence suggests that acupuncture can improve pelvic pain in women with endometriosis. The treatments used in research vary considerably. It remains unclear which treatment could be recommended for clinical practice. This research project aimed at clarifying how acupuncture could be used when treating this condition. Methods: This research comprised two phases: a systematized literature review to extract acupuncture treatment details from published research, and an e-Delphi study to gain knowledge about details as used by expert acupuncturists. Review: Four databases were searched using predefined eligibility criteria. Data were extracted based on the STandards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) criteria. e-Delphi: Purposeful sampling from colleagues and international experts. An open first round gathered qualitative data, analyzed with the Framework method. In rounds 2 and 3, experts rated statements to build group consensus, defined as a rating of ≥5 on a 7-point Likert scale by ≥70% of the experts. The strength of agreement was graded using the median score and interquartile range. Results from the literature review and the e-Delphi were compared using the STRICTA items. Results: The literature review (n = 29 unique studies) found a wide range of treatment details with little agreement. The e-Delphi of international experts (n = 20) resulted in agreement on 94 statements (such as key factors for effectiveness); disagreement on a further 29 (such as acupressure); and absence of consensus on 55 statements (such as the number of needle insertions). A comparison of the review and e-Delphi results found little agreement. Conclusions: Details of acupuncture treatment for endometriosis-related pelvic pain were presented. In the absence of acupuncture guidelines for this condition, the researchers of this e-Delphi recommend using the treatment details on which experts agreed as guidance for good practice. The effectiveness of these guidelines should be evaluated in future research. Study registration: Deutsches Register Klinischer Studien, DRKS00022215, June 30, 2020, retrospectively registered.

Dataset Information

Effects of a Delphi consensus acupuncture treatment protocol on the levels of stress and vascular tone in women undergoing in-vitro fertilization: a randomized clinical trial protocol.

Publications

Effects of a Delphi consensus acupuncture treatment protocol on the levels of stress and vascular tone in women undergoing in-vitro fertilization: a randomized clinical trial protocol.

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