When similar live birth rates do not mean protocol equivalence in frozen embryo transfer.

IF 2.8 3区医学 Q2 GENETICS & HEREDITY

Journal of Assisted Reproduction and Genetics Pub Date : 2026-08-10 DOI:10.1007/s10815-026-03998-9

Dang Anh Tuan

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引用次数: 0

Abstract

Similar live birth rates in frozen embryo transfer (FET) trials can be over-read as evidence that natural, modified natural, and programmed endometrial preparation protocols are biologically equivalent. This interpretation is not warranted when cancellation, delayed transfer, and rescue switching are built into care. Under these conditions, randomization compares starting strategies that unfold through managed clinical pathways, not uninterrupted protocols completed exactly as assigned. Using recent FET trials as practical examples, this Clinical Opinion argues for a narrower and more constructive interpretation: similar live birth supports pathway effectiveness only for the estimand that was actually analyzed. Clinicians should ask whether the reported effect reflects assignment to an initial strategy, completion of the first assigned protocol, or a hypothetical no-switch contrast. Cancellation and rescue switching should be treated as outcomes; pathway burden should be reported alongside live birth, and safety outcomes should use denominators aligned with the stage at which harms occur. These FET-specific reporting recommendations apply existing CONSORT, CONSORT Harms, and ICH E9(R1) principles to trials in which cancellation or switching can materially affect interpretation.

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当相似的活产率并不意味着冷冻胚胎移植的协议等效。

冷冻胚胎移植（FET）试验中相似的活产率可能被过度解读为自然、改良自然和程序化子宫内膜制备方案在生物学上是等效的证据。当取消、延迟转移和救援切换被内置到护理中时，这种解释是不合理的。在这些条件下，随机化比较了通过管理临床路径展开的启动策略，而不是完全按照指定完成的不间断协议。以最近的FET试验为例，本《临床意见》提出了一个更狭隘、更有建设性的解释：类似的活产仅对实际分析的估计支持路径有效性。临床医生应该询问报告的效果是否反映了初始策略的分配，完成了第一个指定的方案，还是假设的无切换对比。取消和救助切换应作为结果处理；路径负担应与活产一起报告，安全结果应使用与危害发生阶段一致的分母。这些针对fet的报告建议将现有的CONSORT、CONSORT危害和ICH E9（R1）原则应用于取消或切换可能对解释产生重大影响的试验。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Assisted Reproduction and Genetics 医学-妇产科学

CiteScore

5.70

自引率

9.70%

发文量

286

审稿时长

1 months

期刊介绍： The Journal of Assisted Reproduction and Genetics publishes cellular, molecular, genetic, and epigenetic discoveries advancing our understanding of the biology and underlying mechanisms from gametogenesis to offspring health. Special emphasis is placed on the practice and evolution of assisted reproduction technologies (ARTs) with reference to the diagnosis and management of diseases affecting fertility. Our goal is to educate our readership in the translation of basic and clinical discoveries made from human or relevant animal models to the safe and efficacious practice of human ARTs. The scientific rigor and ethical standards embraced by the JARG editorial team ensures a broad international base of expertise guiding the marriage of contemporary clinical research paradigms with basic science discovery. JARG publishes original papers, minireviews, case reports, and opinion pieces often combined into special topic issues that will educate clinicians and scientists with interests in the mechanisms of human development that bear on the treatment of infertility and emerging innovations in human ARTs. The guiding principles of male and female reproductive health impacting pre- and post-conceptional viability and developmental potential are emphasized within the purview of human reproductive health in current and future generations of our species. The journal is published in cooperation with the American Society for Reproductive Medicine, an organization of more than 8,000 physicians, researchers, nurses, technicians and other professionals dedicated to advancing knowledge and expertise in reproductive biology.