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反复妊娠丢失(RPL)患者行体外受精-冻融胚胎移植(IVF-FET)后是否进行植入前胚胎遗传学检测(PGT-A)对妊娠结局的影响:一项 SART-CORS 研究。

Pregnancy outcomes following in vitro fertilization frozen embryo transfer (IVF-FET) with or without preimplantation genetic testing for aneuploidy (PGT-A) in women with recurrent pregnancy loss (RPL): a SART-CORS study.

机构信息

Reproductive Gynecology and Infertility, Akron, OH, USA.

Department of Obstetrics, Gynecology and Women's Health, Rutgers New Jersey Medical School, Newark, NJ, USA.

出版信息

Hum Reprod. 2021 Jul 19;36(8):2339-2344. doi: 10.1093/humrep/deab117.

Abstract

STUDY QUESTION

Can preimplantation genetic testing for aneuploidy (PGT-A) improve the live birth rate in patients with recurrent pregnancy loss (RPL)?

SUMMARY ANSWER

PGT-A use was associated with improved live birth rates in couples with recurrent pregnancy loss undergoing frozen embryo transfer (IVF-FET).

WHAT IS KNOWN ALREADY

Euploid embryo transfer is thought to optimize outcomes in some couples with infertility. There is insufficient evidence, however, supporting this approach to management of recurrent pregnancy loss.

STUDY DESIGN, SIZE, DURATION: This study included data collected by the Society of Assisted Reproductive Technologies Clinical Outcomes Reporting System (SART-CORS) for IVF-FET cycles between years 2010 through 2016. A total of 12 631 FET cycles in 10 060 couples were included in this analysis designed to assess the utility of PGT-A in couples with RPL undergoing FET, including 4287 cycles in couples with tubal disease who formed a control group.

PARTICIPANTS/MATERIALS, SETTING, METHODS: The experimental group included couples with RPL (strictly defined as a history of 3 or more pregnancy losses) undergoing FET with or without PGT-A. The primary outcome was live birth rate. Secondary outcomes included rates of clinical pregnancy, spontaneous abortion, and biochemical pregnancy loss. Differences were analyzed using generalized estimating equations logistic regression models to account for multiple cycles per patient. Covariates included in the model were age, gravidity, geographic region, race/ethnicity, smoking history, and indication for assisted reproductive technologies. Analyses were stratified for age groups as defined by SART: <35 years, 35-37 years, 38-40 years, 41-42 years, and >42 years.

MAIN RESULTS AND THE ROLE OF CHANCE

In women with a diagnosis of RPL, the adjusted odds ratio (OR) comparing IVF-FET with PGT-A versus without PGT-A for live birth outcome was 1.31 (95% CI: 1.12, 1.52) for age <35 years, 1.45 (95% CI: 1.21, 1.75) for ages 35-37 years, 1.89 (95% CI: 1.56, 2.29) for ages 38-40, 2.62 (95% CI: 1.94-3.53) for ages 41-42, and 3.80 (95% CI: 2.52, 5.72) for ages >42 years. For clinical pregnancy, the OR was 1.26 (95% CI: 1.08, 1.48) for age <35 years, 1.37 (95% CI: 1.14, 1.64) for ages 35-37 years, 1.68 (95% CI: 1.40, 2.03) for ages 38-40 years, 2.19 (95% CI: 1.65, 2.90) for ages 41-42, and 2.31 (95% CI: 1.60, 3.32) for ages >42 years. Finally, for spontaneous abortion, the OR was 0.95 (95% CI: 0.74, 1.21) for age <35 years, 0.85 (95% CI: 0.65, 1.11) for ages 35-37 years, 0.81 (95% CI: 0.60, 1.08) for ages 38-40, 0.86 (95% CI: 0.58, 1.27) for ages 41-42, and 0.58 (95% CI: 0.32, 1.07) for ages >42 years.

LIMITATIONS, REASONS FOR CAUTION: The retrospective collection of data including only women with recurrent pregnancy loss undergoing FET presents a limitation of this study, and results may not be generalizable to all couples with recurrent pregnancy loss. Also, data regarding evaluation and treatment for RPL for the included women is unavailable.

WIDER IMPLICATIONS OF THE FINDINGS

This is the largest study to date assessing the utility of PGT-A in women with RPL. PGT-A was associated with improvement in live birth and clinical pregnancy in women with RPL, with the largest difference noted in the group of women with age greater than 42 years. Couples with RPL warrant counseling on all management options to reduce subsequent miscarriage, which may include IVF with PGT-A for euploid embryo selection.

STUDY FUNDING/COMPETING INTEREST(S): There are no conflicts of interest to declare.

TRIAL REGISTRATION NUMBER

N/A.

摘要

研究问题

胚胎植入前遗传学检测(PGT-A)能否提高复发性流产(RPL)患者的活产率?

总结答案

PGT-A 的使用与冷冻胚胎移植(IVF-FET)中复发性流产患者的活产率提高相关。

已知情况

人们认为胚胎整倍体转移可以优化一些不孕夫妇的治疗结局。然而,支持这种管理复发性流产的方法的证据不足。

研究设计、规模、持续时间:本研究纳入了 2010 年至 2016 年期间通过辅助生殖技术协会临床结果报告系统(SART-CORS)收集的 IVF-FET 周期数据。共纳入了 10060 对夫妇的 12631 个 FET 周期,旨在评估 RPL 患者行 FET 时 PGT-A 的效用,包括 4287 个输卵管疾病患者的周期作为对照组。

参与者/材料、设置、方法:实验组包括有 RPL(严格定义为有 3 次或更多次妊娠丢失)病史的夫妇,他们接受了 FET 治疗,包括或不包括 PGT-A。主要结局是活产率。次要结局包括临床妊娠率、自然流产率和生化妊娠丢失率。使用广义估计方程逻辑回归模型分析差异,以考虑每个患者的多个周期。纳入模型的协变量包括年龄、孕次、地理位置、种族/民族、吸烟史和辅助生殖技术的适应证。分析按 SART 定义的年龄组分层:<35 岁、35-37 岁、38-40 岁、41-42 岁和>42 岁。

主要结果和机会作用

在诊断为 RPL 的女性中,PGT-A 与 IVF-FET 相比,活产结局的调整优势比(OR)为<35 岁年龄组为 1.31(95%CI:1.12,1.52),35-37 岁年龄组为 1.45(95%CI:1.21,1.75),38-40 岁年龄组为 1.89(95%CI:1.56,2.29),41-42 岁年龄组为 2.62(95%CI:1.94,3.53),>42 岁年龄组为 3.80(95%CI:2.52,5.72)。对于临床妊娠,<35 岁年龄组的 OR 为 1.26(95%CI:1.08,1.48),35-37 岁年龄组为 1.37(95%CI:1.14,1.64),38-40 岁年龄组为 1.68(95%CI:1.40,2.03),41-42 岁年龄组为 2.19(95%CI:1.65,2.90),>42 岁年龄组为 2.31(95%CI:1.60,3.32)。最后,对于自然流产,<35 岁年龄组的 OR 为 0.95(95%CI:0.74,1.21),35-37 岁年龄组为 0.85(95%CI:0.65,1.11),38-40 岁年龄组为 0.81(95%CI:0.60,1.08),41-42 岁年龄组为 0.86(95%CI:0.58,1.27),>42 岁年龄组为 0.58(95%CI:0.32,1.07)。

局限性、谨慎的原因:本研究仅纳入了接受 FET 的复发性流产患者,回顾性地收集数据,这是该研究的一个局限性,并且研究结果可能不适用于所有复发性流产的夫妇。此外,纳入的女性的 RPL 评估和治疗数据不可用。

研究结果的意义

这是迄今为止评估 PGT-A 在 RPL 患者中的效用的最大规模的研究。PGT-A 与 RPL 患者的活产和临床妊娠改善相关,年龄大于 42 岁的患者组差异最大。RPL 夫妇应接受所有管理选择的咨询,以减少随后的流产,包括用于胚胎整倍体选择的 IVF 联合 PGT-A。

研究资金/利益冲突:没有利益冲突需要声明。

临床试验注册号

无。

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