چهارشنبه 8 بهمن 1404
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دوره 23، شماره 11 - ( 8-1404 )
جلد 23 شماره 11 صفحات 963-961 |
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Chow E, To E, Chow T K F. The effect of intrauterine injection of autologous peripheral blood mononuclear cells on clinical pregnancy in women with recurrent implantation failure. IJRM 2025; 23 (11) :961-963
URL: http://ijrm.ir/article-1-3575-fa.html
URL: http://ijrm.ir/article-1-3575-fa.html
The effect of intrauterine injection of autologous peripheral blood mononuclear cells on clinical pregnancy in women with recurrent implantation failure. International Journal of Reproductive BioMedicine. 1404; 23 (11) :961-963
چکیده: (24 مشاهده)
We wish to commend Fazaeli et al. for their randomized controlled trial comparing intrauterine autologous peripheral blood mononuclear cells (PBMC) infusion and platelet-rich plasma on the pregnancy rate of women with recurrent implantation failure (RIF) (1). Recent European Society of Human Reproduction and Embryology Good Practice Recommendations on RIF have not endorsed intrauterine immunotherapies, including PBMC (2). We believe these conclusions were based on outdated systematic reviews and meta-analyses with limited controlled clinical trials and small sample sizes. Yoshioka et al. were the first investigators to demonstrate the promise of PBMC in managing RIF (3). However, subsequent publications of conflicting evidence over the past 18 yr have hindered the adoption of this intrauterine immunotherapy. My co-authors and I have closely followed the progress of this topic, and we believe that the results from Fazaeli et al. are consistent with those of other published randomized controlled trials, supporting that intrauterine PBMC can enhance the clinical pregnancy rate of patients with RIF.
We systematically searched OVID MEDLINE and Embase from inception (1945 and 1974 respectively) to 22 October 2025. This meta-analysis was prospectively registered with the International Prospective Register of Systematic Reviews (ID: CRD42024421275) and performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis. Our results were presented at the recent International Federation of Fertility Societies World Congress, Tokyo, Japan (4). The results of our meta-analysis showed that a pooled analysis of 10 controlled clinical trials (n = 1503) comparing intrauterine PBMC with control (another standard stimulation cycle for embryo transfer) showed a modest effect size of risk ratio (RR) = 1.60 (1.24-2.06). Upon visual inspection of the forest plot, moderate heterogeneity was observed with poor alignment of 95% confidence interval (CI), statistically significant at p = 0.02 and I2 = 55% (Figure 1A). An investigation of heterogeneity using subgroup analysis considering “trial randomization” demonstrated 2 distinct, homogenous effect sizes with non-overlapping 95% CI. The efficacy of intrauterine PBMC in 6 randomized controlled trials (n = 604), was RR = 2.12 (1.62-2.78, p = 0.74 and I2 = 0%) compared to 4 non-randomized controlled trials (n = 899), RR = 1.17 (0.98-1.40, including 1.0 and hence statistically insignificant, p = 0.35 and I2 = 8%), respectively (Figure 1B). The combination of distinct, homogenous effect sizes with non-overlapping 95% CI and p = 0.0003 and I2 = 92.3%, suggests that differing trial design was the sole source of heterogeneity/conflict.
The publication of non-randomized controlled trials may offer savings in cost and time, potentially leading to early awareness of innovative therapies. However, this approach may be counterproductive in RIF research due to flawed non-randomized controls (i.e., retrospective cohorts, patients refusing consent, patients without RIF, or those undergoing their first embryo transfer). Our data suggest that non-randomized controlled trials significantly obscure the efficacy of PBMC and contribute to “inconsistent findings” and “conflicting results”. The true efficacy of PBMC is evidenced in the randomized controlled trials, which can significantly increase the clinical pregnancy rate. We believe that our timely update of this meta-analysis provides important information for established authorities such as the European Society of Human Reproduction and Embryology RIF Working group to reconsider their recommendation regarding intrauterine PBMC in managing patients with RIF.
We systematically searched OVID MEDLINE and Embase from inception (1945 and 1974 respectively) to 22 October 2025. This meta-analysis was prospectively registered with the International Prospective Register of Systematic Reviews (ID: CRD42024421275) and performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analysis. Our results were presented at the recent International Federation of Fertility Societies World Congress, Tokyo, Japan (4). The results of our meta-analysis showed that a pooled analysis of 10 controlled clinical trials (n = 1503) comparing intrauterine PBMC with control (another standard stimulation cycle for embryo transfer) showed a modest effect size of risk ratio (RR) = 1.60 (1.24-2.06). Upon visual inspection of the forest plot, moderate heterogeneity was observed with poor alignment of 95% confidence interval (CI), statistically significant at p = 0.02 and I2 = 55% (Figure 1A). An investigation of heterogeneity using subgroup analysis considering “trial randomization” demonstrated 2 distinct, homogenous effect sizes with non-overlapping 95% CI. The efficacy of intrauterine PBMC in 6 randomized controlled trials (n = 604), was RR = 2.12 (1.62-2.78, p = 0.74 and I2 = 0%) compared to 4 non-randomized controlled trials (n = 899), RR = 1.17 (0.98-1.40, including 1.0 and hence statistically insignificant, p = 0.35 and I2 = 8%), respectively (Figure 1B). The combination of distinct, homogenous effect sizes with non-overlapping 95% CI and p = 0.0003 and I2 = 92.3%, suggests that differing trial design was the sole source of heterogeneity/conflict.
The publication of non-randomized controlled trials may offer savings in cost and time, potentially leading to early awareness of innovative therapies. However, this approach may be counterproductive in RIF research due to flawed non-randomized controls (i.e., retrospective cohorts, patients refusing consent, patients without RIF, or those undergoing their first embryo transfer). Our data suggest that non-randomized controlled trials significantly obscure the efficacy of PBMC and contribute to “inconsistent findings” and “conflicting results”. The true efficacy of PBMC is evidenced in the randomized controlled trials, which can significantly increase the clinical pregnancy rate. We believe that our timely update of this meta-analysis provides important information for established authorities such as the European Society of Human Reproduction and Embryology RIF Working group to reconsider their recommendation regarding intrauterine PBMC in managing patients with RIF.
نوع مطالعه: Letter to Editor |
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