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子宫内膜搔刮术在体外受精前的随机试验。

A Randomized Trial of Endometrial Scratching before In Vitro Fertilization.

机构信息

From the Department of Obstetrics and Gynaecology, University of Auckland (S.L., D.O., C.F.), and Women's Health (L. Sadler) and Fertility Plus (D.G., C.F.), Auckland District Health Board, Auckland, Fertility Associates, Christchurch (S.A.W.), and Fertility Associates, Wellington (L. Searle, S.M.) - all in New Zealand; Bath Fertility Centre, Bath (S.A., E.N.), the Department of Medical Statistics, Manchester University NHS Foundation Trust, Manchester (J.W.), and the Department of Obstetrics and Gynaecology, King's College Hospital (K.V., H.H.), University College Hospital (L.W.), Homerton Fertility Centre, Homerton University Hospital NHS Foundation Trust (P.B.), and Guy's Hospital (Y.K.), London - all in the United Kingdom; the Department of Obstetrics and Gynecology, Institute of Clinical Sciences, University of Gothenburg, Reproductive Medicine, Sahlgrenska University Hospital, Gothenburg, Sweden (C.S., A.S., C.B.); Leuven University Fertility Center, Department of Obstetrics and Gynecology, University Hospitals, Leuven, Belgium (A.H., K.P.); and Reproductive Services, Royal Women's Hospital, Melbourne, VIC, Australia (W.T.T.).

出版信息

N Engl J Med. 2019 Jan 24;380(4):325-334. doi: 10.1056/NEJMoa1808737.

DOI:10.1056/NEJMoa1808737
PMID:30673547
Abstract

BACKGROUND

Endometrial scratching (with the use of a pipelle biopsy) is a technique proposed to facilitate embryo implantation and increase the probability of pregnancy in women undergoing in vitro fertilization (IVF).

METHODS

We conducted a pragmatic, multicenter, open-label, randomized, controlled trial. Eligible women were undergoing IVF (fresh-embryo or frozen-embryo transfer), with no recent exposure to disruptive intrauterine instrumentation (e.g., hysteroscopy). Participants were randomly assigned in a 1:1 ratio to either endometrial scratching (by pipelle biopsy between day 3 of the cycle preceding the embryo-transfer cycle and day 3 of the embryo-transfer cycle) or no intervention. The primary outcome was live birth.

RESULTS

A total of 1364 women underwent randomization. The frequency of live birth was 180 of 690 women (26.1%) in the endometrial-scratch group and 176 of 674 women (26.1%) in the control group (adjusted odds ratio, 1.00; 95% confidence interval, 0.78 to 1.27). There were no significant between-group differences in the rates of ongoing pregnancy, clinical pregnancy, multiple pregnancy, ectopic pregnancy, or miscarriage. The median score for pain from endometrial scratching (on a scale of 0 to 10, with higher scores indicating worse pain) was 3.5 (interquartile range, 1.9 to 6.0).

CONCLUSIONS

Endometrial scratching did not result in a higher rate of live birth than no intervention among women undergoing IVF. (Funded by the University of Auckland and others; PIP Australian New Zealand Clinical Trials Registry number, ACTRN12614000626662 .).

摘要

背景

子宫内膜搔刮术(使用 Pipelle 活检)是一种旨在促进胚胎着床并提高体外受精(IVF)患者妊娠率的技术。

方法

我们进行了一项实用的、多中心、开放性标签、随机、对照试验。符合条件的女性正在接受 IVF(新鲜胚胎或冷冻胚胎移植),且最近没有接受过干扰性宫内仪器检查(例如宫腔镜检查)。参与者以 1:1 的比例随机分为子宫内膜搔刮组(在胚胎移植周期前的周期第 3 天至胚胎移植周期第 3 天之间进行 Pipelle 活检)或不干预组。主要结局是活产。

结果

共有 1364 名女性接受了随机分组。在子宫内膜搔刮组中,180 名 690 名女性(26.1%)活产,对照组中 176 名 674 名女性(26.1%)活产(调整后的优势比为 1.00;95%置信区间为 0.78 至 1.27)。两组间持续性妊娠、临床妊娠、多胎妊娠、异位妊娠或流产率均无显著差异。子宫内膜搔刮术疼痛评分中位数(0 至 10 分,分数越高表示疼痛越严重)为 3.5 分(四分位间距为 1.9 至 6.0)。

结论

在接受 IVF 的女性中,子宫内膜搔刮术并未比不干预组提高活产率。(由奥克兰大学等资助;PIP 澳大利亚-新西兰临床试验注册编号,ACTRN12614000626662。)

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