| Background:Infertility has become a global medical problem affecting human reproductive health and social development.Currently,In Vitro Fertilization-Embryo Transfer(IVF-ET)and its derivatives are the mainstay of treatment for infertility.According to the American Society for Reproductive Medicine,its current live birth rate hovers around 30%-35%.Several studies have shown that acupuncture has a positive effect in improving egg quality,promoting ovulation,enhancing endometrial tolerance,reducing the incidence of ovarian hyperstimulation syndrome during IVFET and relieving patients’ depression and anxiety.As a result,many doctors and patients have started to use acupuncture as an adjunctive treatment measure for IVF-ET in clinical practice.As the number of published clinical studies and evidence-based evaluations of acupuncture as an adjunct to IVF-ET has increased,the findings have been inconsistent across study types or between the same study design types.Based on this,the aim of this study was to systematically review and summarize the evidence in the field of acupuncture-assisted IVF-ET,including the types of evidence and the current state of the evidence,to identify problems in existing studies,and to identify research gaps and future trends.At the same time,the conclusions of the randomized controlled trials in the above clinical studies were assessed and biased to investigate whether there is any bias in the interpretation of the findings in the conclusions of the randomized controlled trials of acupuncture-assisted IVF-ET,in order to draw the attention of experts and scholars to the phenomenon of bias in the conclusions and to advocate objective reporting of the conclusions of clinical studies on acupuncture.Methods:Eight electronic databases,including PubMed,were systematically searched and supplemented by manual searches of the relevant reference lists of all included literature.The included studies were those of infertile women undergoing IVF-ET,and the interventions consisted of manual acupuncture,electroacupuncture,laser acupuncture,transcutaneous electrical acupoint stimulation,auricular acupuncture and dry needling.The type of comparison was that the intervention group received acupuncture as an adjunct to IVF-ET and the control group did not receive acupuncture treatment or received sham acupuncture(placebo acupuncture)treatment.For outcome indicators,clinical pregnancy rates and/or live birth rates had to be reported for inclusion in the study,and the study design types included randomized controlled trials,clinical randomized controlled trials,cohort studies and systematic reviews.Study screening and data extraction were completed back-to-back by pairs and included systematic evaluations were assessed for methodological quality using AMSTAR-2.The third part of the conclusion bias study was conducted on all randomized controlled trials of acupuncture-assisted IVF-ET included in the second part and their conclusion reporting and bias was evaluated using a modified version of the Randomized Controlled Conclusion Bias Assessment Tool.Results:A total of 82 clinical studies on acupuncture-assisted IVF-ET have been published in the last two decades,including 64 primary studies(of which 47 were randomized controlled trials)and 18 systematic reviews.Of the 63 primary studies reporting clinical pregnancy rates,34(54.0%)showed a positive effect of acupuncture on clinical pregnancy rates in IVF-ET patients,while of the systematic review study evidence,all 18 studies assessed clinical pregnancy rates,and eight(44.4%)showed a positive effect of the acupuncture group on clinical pregnancy rates in women undergoing IVF-ET,but their methodological quality were all low or very low.In terms of live birth rates,only 18 primary studies reported live birth rates,of which 10(55.6%)were positive;14 systematic reviews reported live birth rates,and only 2(14.3%)showed a positive effect of acupuncture on live birth rates,but all of them were of very low methodological quality.There were 11 primary studies reporting ongoing pregnancy rates,with 45.5%positive results,and only one systematic review showing a significant improvement in sustained pregnancy rates with acupuncture during IVFET,which was a very low quality study.In terms of miscarriage rates,22 primary studies evaluated miscarriage rates as an outcome indicator,but only 2(9.1%)studies showed that acupuncture was effective in reducing miscarriage rates in IVF-ET patients;at the same time,no systematic review reported that acupuncture was effective in reducing miscarriage events during IVF-ET.The results of the evaluation of conclusion bias in randomized controlled trials of acupuncture-assisted IVF-ET showed that 45(95.7%)studies had at least one subjective bias entry at the time of conclusion reporting.40(85.1%)studies did not mention specific controls or control measures in their conclusions,and 11(23.4%)of these studies also did not mention specific outcome indicators in their conclusions.21(44.7%)studies had "conclusions using only efficacy outcomes for positive outcomes and/or adverse event outcomes for negative outcomes".Eleven(23.4%)studies "used only positive efficacy outcomes and/or negative adverse event outcomes when no primary or secondary outcome was set to draw conclusions".11(23.4%)studies "used statistically insignificant outcomes to draw positive efficacy conclusions and/or negative safety conclusions".Nine(19.2%)studies "used specific writing or language techniques to modify the description of the results in the conclusions in a directional manner".7(14.9%)studies reported conclusions with "a focus on the difference being statistically significant and not on whether the difference was statistically significant".statistical significance,but not whether the difference was clinically significant" and"clinical application was recommended without considering the limitations of the study" and "clinical application was recommended without considering the safety of the intervention Five studies(10.6%)had a subjective bias of "using an unpredetermined outcome in the methods section to draw conclusions",of which two studies used an unpredetermined outcome of "clinical signs or symptoms in Chinese medicine" in their conclusions,and one study used an unpredetermined outcome of"clinical signs or symptoms in Chinese medicine"."One study used an unreported"subendometrial blood flow" outcome,one study used an unobserved safety outcome to draw conclusions,and one study used both an unobserved or reported safety outcome and a quality of life outcome to draw conclusions.Conclusions:Overall,the amount of published research evidence in the field of acupuncture-assisted in vitro fertilization embryo transfer is significant,including 64 primary studies and 18 systematic reviews.The available research evidence tends to support that assisted needling during IVF-ET improves clinical pregnancy rates,which makes it difficult to analyze whether acupuncture increases live birth events due to the small number of primary studies reporting live birth rates.Furthermore,although the number of published systematic reviews in the field of acupuncture-assisted IVF-ET is considerable,the methodological quality is not promising.In our evaluation of conclusion bias in randomized controlled trials of acupuncture-assisted IVF-ET,we found that 95.7%of studies had at least one entry of conclusion bias,with the most common type of conclusion bias being inappropriate extrapolation of findings,mainly in the form of inappropriate extrapolation of findings to other populations,diseases,interventions,controls or outcomes,without adequate consideration of the trial PICO when drawing conclusions.The most common type of bias was inappropriate extrapolation of findings to other populations,diseases,interventions,controls or outcomes. |
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