ART-ET筛查工具:一种易于使用的无创筛查方法,可提前预测胚胎移植困难。

IF 6 1区 医学 Q1 OBSTETRICS & GYNECOLOGY
Baris Ata, Barbara Lawrenz, Laura Melado, Raquel Del Gallego, Carol Coughlan, Francisco Ruiz, Laura Marqueta Marques, Ahmed El-Damen, Ibrahim Elkhatib, Human M Fatemi
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引用次数: 0

摘要

研究问题:ART-ET筛查工具是一种易于使用的非侵入性筛查工具,用于预测困难的胚胎移植,其诊断性能如何?总结回答:宫颈管经阴道超声检查简单评分,预测胚胎移植困难,特异性高,阳性似然比高,准确率高;包括宫颈位置和无阴道分娩剖宫产史提高了预测性能。已知情况:困难的胚胎移植程序与较低的临床妊娠率和活产率相关,一些干预措施可能会促进预期的困难胚胎移植。研究设计、规模、持续时间:一项对2023年3月至12月239例单整倍体囊胚移植手术进行前瞻性诊断试验研究。计算样本量,包括大约20个困难的转移程序。进行转移的医生对筛查结果是不知情的。对象/材料、环境、方法:本研究在两个三级私立辅助生殖中心进行。ART-ET筛查工具收集了患者的体重指数、产科史、宫颈体位、宫颈外口外观、宫颈管超声检查等信息。如果在手术过程中出现以下一种或多种情况,则定义为困难的胚胎移植;使用可伸缩的闭孔将引导导管插入内口,使用镊子拉宫颈,如果手术后转移导管中有血,如果转移导管需要重新加载,如果医生发现手术困难。主要结果和偶然性的作用:困难和容易胚胎移植后的持续妊娠率分别为47.6%和59.6%。在胚胎移植困难发生率为8.8%的情况下,宫颈位置、宫颈可视性、宫颈管长度、产科史等筛查评分对胚胎移植困难的诊断效果最好,敏感性为33.3%(14.59 ~ 56.97%),特异性为99.5%(97.47 ~ 99.99%),阳性似然比为72.67(9.38 ~ 562.73),阴性似然比为0.67(0.49 ~ 0.91),预测胚胎移植困难的准确率为93.7%(89.86 ~ 96.45%)。宫颈超声简单评分也具有较好的诊断效果,灵敏度为28.6%(11.28 ~ 52.18%),特异性为98.2%(95.37 ~ 99.50%),阳性似然比为15.57(4.77 ~ 50.84),阴性似然比为0.73(0.55 ~ 0.95),阳性预测值为60.0%(31.46 ~ 83.03%),阴性预测值为93.5%(91.59 ~ 94.93%),准确率为93.5%(91.59 ~ 94.93%)。局限性,谨慎的原因:拟议的ART-ET筛查工具的诊断性能将取决于临床中胚胎移植困难的流行程度。评分系统能在多大程度上减少胚胎移植的困难,提高活产率,还需要进一步的研究来确定。研究结果的更广泛含义:对困难转移的预期可以帮助调整患者的期望并提前采取适当的措施。研究经费/竞争利益:没有收到本研究的经费。所有作者都没有与本研究相关的任何竞争利益。试验注册号:NCT05701072。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
The ART-ET screening tool: an easy-to-use non-invasive screening method to predict difficult embryo transfers in advance.

Study question: What is the diagnostic performance of the ART-ET screening tool, an easy-to-use non-invasive screening tool for prediction of difficult embryo transfers?

Summary answer: A simple scoring of transvaginal ultrasound examination of the cervical canal can predict difficult embryo transfers with high specificity, positive likelihood ratio, and accuracy; the inclusion of cervical position and history of cesarean without a vaginal delivery improved predictive performance.

What is known already: Difficult embryo transfer procedures are associated with significantly lower clinical pregnancy and live birth rates, and some interventions may facilitate an anticipated difficult embryo transfer.

Study design, size, duration: A diagnostic test study prospectively conducted on 239 single euploid blastocyst transfer procedures between March and December 2023. The sample size was calculated to include about 20 difficult transfer procedures. Physicians conducting the transfers were blinded to screening results.

Participants/materials, setting, methods: The study was conducted in two tertiary-level private assisted reproduction centers. The ART-ET Screening tool collected information on patients' body mass index, obstetric history, cervical position, external cervical ostium appearance, and ultrasound examination of the cervical canal. A difficult embryo transfer was defined if one or more of the following occurred during the procedure; use of a malleable obturator to insert the guiding catheter until the internal ostium, use of a forceps to pull the cervix, if there were blood in the transfer catheter following the procedure, if the transfer catheter needed to be reloaded, and if the physician found the procedure difficult.

Main results and the role of chance: Ongoing pregnancy rates were 47.6% vs 59.6% after a difficult and easy embryo transfer. With a difficult embryo transfer prevalence of 8.8%, screening score including cervical position, visibility and the length of cervical canal, and obstetric history had the best diagnostic performance with sensitivity of 33.3% (14.59-56.97%), specificity of 99.5% (97.47-99.99%), positive likelihood ratio of 72.67 (9.38-562.73), negative likelihood ratio of 0.67 (0.49-0.91), and an accuracy of 93.7% (89.86-96.45%) for predicting difficult embryo transfers. The simpler cervical ultrasound score also had a good diagnostic performance with a sensitivity of 28.6% (11.28-52.18%), specificity of 98.2% (95.37-99.50%), positive likelihood ratio of 15.57 (4.77-50.84), negative likelihood ratio of 0.73 (0.55-0.95), positive predictive value of 60.0% (31.46-83.03%), negative predictive value of 93.5% (91.59-94.93%), and an accuracy of 93.5% (91.59-94.93%).

Limitations, reasons for caution: The diagnostic performance of the proposed ART-ET Screening tool would depend on the prevalence of difficult embryo transfers in a clinic. How much the scoring system can decrease difficult embryo transfers and improve live birth rates need to be determined in further studies.

Wider implications of the findings: Anticipation of a difficult transfer can help to adjust patient expectations and to take appropriate measures in advance.

Study funding/competing interest(s): No funding was received for the study. None of the authors have any competing interests associated with the present study.

Trial registration number: NCT05701072.

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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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