Genest Genevieve, Hochberg Alyssa, Boivin Martine, Ferreira Alexie, Liu Zhiyang, Beauchamp Coralie, Beltempo Marc, Dahan Michael H, Dahdouh Elias M, Demirtas Ezgi, Hemmings Robert, Jamal Wael, Kadoch Isaac-Jacques, Lapensée Louise, Mahutte Neal, Phillips Simon, Reinblatt Shauna, Sylvestre Camille, Buckett William, Mazer Bruce D, Piccirillo Ciriaco A
Division of Clinical Immunology and Allergy, Department of Medicine, McGill University Health Centre, Montréal, Québec, Canada.
Division of Reproductive Endocrinology and Infertility, Department of Obstetrics and Gynecology, McGill University, McGill University Health Centre, Montréal, Québec, Canada.
Am J Reprod Immunol. 2025 Aug;94(2):e70131. doi: 10.1111/aji.70131.
A proportion of patients with unexplained recurrent implantation failure (uRIF) may have endometrial immune dysregulation amenable to treatment. Ultimpro (Matrice lab Innove, Paris, France) is an endometrial immunophenotype test which identifies the absence or presence and type of immune dysregulation, proposing personalized protocol adjustments for a future embryo transfer (ET).
2.5-year single-center retrospective cohort analysis of 121 patients who underwent Ultimpro testing as a pilot study (January 2021-May 2023). Group 1 included 93 patients with uRIF, and Group 2 included 28 patients without RIF. Outcomes from Group 1 were compared to Group 3, a control cohort of 94 uRIF patients, outcomes for Group 2 were compared to Canadian average ongoing pregnancy rates (OPR) per ET. Primary outcome was pregnancy >32 weeks or live birth. Statistical analyses included the Student t-test or Mann-Whitney U test for continuous variables and the Fisher exact test for categorical data.
In Group 1, 46/93 (49.5%) patients had a successful pregnancy compared to control (31/94 [33%], p = 0.026); when stratifying for RIF severity, patients with ≥ 5 failed blastocyst transfers benefitted most from Ultimpro (21/38 [55.3%] vs. control 5/25 (20.0%), p = 0.0084). In Group 2, rates of OPR per ET with Ultimpro recommendations did not differ from outcomes for non-RIF patients (9/28 [32.1%]; 95% CI: 0.15-0.52 vs. 46.2%).
In patients with uRIF, our preliminary findings suggest that application of Ultimpro recommendations was associated with a higher rate of successful outcomes; this was not the case for patients without RIF. These findings provide the rationale for an independent randomized controlled trial evaluating the large-scale use of Ultimpro in patients with uRIF.
一部分不明原因反复种植失败(uRIF)的患者可能存在可治疗的子宫内膜免疫失调。Ultimpro(法国巴黎的Matrice lab Innove公司)是一种子宫内膜免疫表型检测,可识别免疫失调的缺失、存在情况及类型,并为未来的胚胎移植(ET)提出个性化方案调整建议。
对121例接受Ultimpro检测作为试点研究的患者(2021年1月至2023年5月)进行了为期2.5年的单中心回顾性队列分析。第1组包括93例uRIF患者,第2组包括28例无种植失败(RIF)的患者。将第1组的结果与第3组(94例uRIF患者的对照队列)进行比较,将第2组的结果与加拿大每次ET的平均持续妊娠率(OPR)进行比较。主要结局是妊娠超过32周或活产。统计分析包括对连续变量采用Student t检验或Mann-Whitney U检验,对分类数据采用Fisher精确检验。
在第1组中,46/93(49.5%)的患者成功妊娠,而对照组为31/94(33%),p = 0.026;按RIF严重程度分层时,≥5次囊胚移植失败的患者从Ultimpro中获益最大(21/38 [55.3%] 对比对照组5/25 [20.0%],p = 0.0084)。在第2组中,根据Ultimpro建议的每次ET的OPR率与非RIF患者的结果无差异(9/28 [32.1%];95% CI:0.15 - 0.52对比46.2%)。
在uRIF患者中,我们的初步研究结果表明,应用Ultimpro建议与更高的成功结局率相关;对于无RIF的患者则并非如此。这些发现为一项独立的随机对照试验提供了理论依据,该试验旨在评估Ultimpro在uRIF患者中的大规模应用。