基于透明质酸的移植介质对反复植入失败患者冻融胚胎移植结果的临床影响:一项随机对照试验

IF 6 1区 医学 Q1 OBSTETRICS & GYNECOLOGY
K D Nayar, S Sanan, M Sachdeva, S Arora, G Kant, A Arora, A Singh, K Nayar
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引用次数: 0

摘要

研究问题:富含透明质酸(HA)的移植培养基能否改善反复植入失败女性冷冻胚胎移植的结果?基于透明质酸的胚胎移植培养基可显著提高冷冻胚胎移植中反复植入失败患者的临床妊娠率和着床率。复发性着床失败(RIF)是约10%接受辅助生殖的患者面临的重大挑战,通常受胚胎和子宫内膜相互作用的影响,导致结果不成功。标准胚胎移植介质可能不能充分支持这些患者的胚胎着床。透明质酸(HA)已被提出作为一种潜在的添加剂,以加强植入,因为它参与细胞相互作用。一些研究表明,富含ha的培养基可以提高胚胎附着和着床率,但其对接受冻融胚胎移植的RIF患者的疗效的证据仍然有限且不确定。从2022年1月1日至2024年10月31日,在我们的三级IVF中心进行了一项前瞻性随机对照试验,以评估富含ha的胚胎移植培养基对接受冷冻解冻胚胎移植(FET)的复发性植入失败(RIF)患者结局的影响。共有150名妇女被随机分配到HA组(n = 75)和对照组(n = 75)。主要结局是临床妊娠,次要结局包括着床、流产和持续妊娠率。参与者/材料,环境,方法参与者为37岁以下的女性,卵巢储备正常,至少有三次失败的新鲜或冷冻胚胎移植史,包括三个周期(RIF)中的四个优质胚胎。排除标准包括内分泌或子宫疾病、精液参数异常和使用供体卵母细胞。共有150名妇女被随机分为HA组和对照组。所有患者均接受激素替代治疗(HRT)周期,并移植单个a级解冻囊胚。与对照组相比,富透明质酸胚胎移植培养基(HA)组患者的临床妊娠率(超声显示至少一个孕囊有或无心脏活动)有统计学意义的增加(42%对28%,p = 0.035)。此外,HA组的着床率更高(31%比18%,p = 0.041)。然而,两组的流产率无显著差异(12% vs 15%, p = 0.64)。持续妊娠率(妊娠持续超过12周)显示HA组有趋势,但差异无统计学意义(38%对32%,p = 0.51)。采用SPSS软件进行统计分析。根据数据分布应用统计检验:对于连续变量的比较,采用学生t检验和分类变量的Fisher精确检验。通过计算p值来评价统计学显著性。这些研究结果表明,基于ha的转移介质可能提供一种潜在的治疗策略,以提高有RIF病史患者的临床妊娠和着床率。进一步的研究需要更大的样本量和更长时间的随访来证实这些结果并评估长期的生殖结果。本研究的局限性包括样本量相对较小、单中心设计和随访时间有限。此外,透明质酸对子宫内膜容受性等因素的影响尚未探讨,这可能会影响研究结果的普遍性。研究结果的更广泛意义:添加透明质酸的胚胎移植培养基可显著提高复发性植入失败患者的临床妊娠和着床率,表明其有可能提高该队列的体外受精成功率。试验注册号是
本文章由计算机程序翻译,如有差异,请以英文原文为准。
P-452 Clinical impact of hyaluronic acid-based transfer medium on frozen–thawed embryo transfer outcome in recurrent implantation failure patients: a randomized controlled trial
Study question Can Hyaluronic acid ( HA) -enriched transfer medium improve the outcome of frozen embryo transfer in women with recurrent implantation failure? Summary answer Hyaluronic acid-based embryo transfer medium significantly improves clinical pregnancy and implantation rates in recurrent implantation failure patients undergoing frozen-thawed embryo transfer. What is known already Recurrent implantation failure (RIF) is a significant challenge in about 10% of patients undergoing assisted reproduction,often influenced by interactions between the embryo and the endometrium,leading to unsuccessful outcomes. Standard embryo transfer media may not adequately support embryo implantation in these patients. Hyaluronic acid (HA) has been proposed as a potential additive to enhance implantation, as it is involved in cellular interactions. Some studies indicate that HA-enriched media may improve embryo attachment and implantation rates, but evidence on its efficacy in RIF patients undergoing frozen-thawed embryo transfer remains limited and inconclusive. Study design, size, duration A prospective randomized controlled trial was conducted at our tertiary IVF Centre from 1st January 2022 to 31st October 2024 to assess the effect of HA-enriched embryo transfer medium on outcomes in recurrent implantation failure (RIF) patients undergoing frozen-thawed embryo transfer (FET). A total of 150 women were randomly assigned to the HA group (n = 75) or the control group (n = 75). Primary outcome was clinical pregnancy while secondary outcome included implantation, miscarriage, and ongoing pregnancy rates. Participants/materials, setting, methods Participants were women under 37 years with normal ovarian reserve and a history of at least three failed fresh or frozen embryo transfers, involving four good-quality embryos across three cycles(RIF). Exclusion criteria included endocrine or uterine disorders, abnormal semen parameters, and use of donor oocytes. A total of 150 women were randomized into either the HA or control group. All underwent hormone replacement therapy (HRT) cycles with transfer of a single grade A thawed blastocyst. Main results and the role of chance Patients in the hyaluronic acid-enriched embryo transfer medium (HA) group showed a statistically significant increase in clinical pregnancy rates (an ultrasonic visualization of at least one gestional sac with or without cardiac activity) compared to the control group (42% vs. 28%, p = 0.035). Furthermore, the implantation rate was higher in the HA group (31% vs. 18%, p = 0.041). However, no significant difference was found in miscarriage rates (12% vs. 15%, p = 0.64) between the two groups. The ongoing pregnancy rate (Pregnancy continuing beyond 12th week ) showed a trend favoring the HA group, though this difference was not statistically significant (38% vs. 32%, p = 0.51). Statistical analysis was performed by the SPSS program for Windows version 25.0. Statistical tests applied according to the distribution of data: for comparing continuous variables-Student t-test and Fisher exact test for categorical variables . The statistical significance was evaluated by calculating the p-value.These findings suggest that HA-based transfer media may offer a potential therapeutic strategy to enhance clinical pregnancy and implantation rates in patients with previous history of RIF. Further research with larger sample sizes and extended follow-up is warranted to confirm these results and evaluate long-term reproductive outcomes. Limitations, reasons for caution This study’s limitations include a relatively small sample size, single-centre design, and limited follow-up period. Additionally, the impact of hyaluronic acid on factors like endometrial receptivity was not explored, which may affect the generalizability of the findings. Wider implications of the findings Hyaluronic acid-enriched embryo transfer medium as an add-on significantly improved clinical pregnancy and implantation rates in recurrent implantation failure patients, suggesting its potential to enhance IVF success in this cohort. Trial registration number Yes
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来源期刊
Human reproduction
Human reproduction 医学-妇产科学
CiteScore
10.90
自引率
6.60%
发文量
1369
审稿时长
1 months
期刊介绍: Human Reproduction features full-length, peer-reviewed papers reporting original research, concise clinical case reports, as well as opinions and debates on topical issues. Papers published cover the clinical science and medical aspects of reproductive physiology, pathology and endocrinology; including andrology, gonad function, gametogenesis, fertilization, embryo development, implantation, early pregnancy, genetics, genetic diagnosis, oncology, infectious disease, surgery, contraception, infertility treatment, psychology, ethics and social issues.
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