Assisted Conception Unit, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK.
Sheffield Clinical Trials Research Unit (CTRU), School of Health and Related Research (ScHARR), The University of Sheffield, Sheffield, UK.
Health Technol Assess. 2022 Jan;26(10):1-212. doi: 10.3310/JNZT9406.
In vitro fertilisation is a widely used reproductive technique that can be undertaken with or without intracytoplasmic sperm injection. The endometrial scratch procedure is an in vitro fertilisation 'add-on' that is sometimes provided prior to the first in vitro fertilisation cycle, but there is a lack of evidence to support its use.
(1) To assess the clinical effectiveness, safety and cost-effectiveness of endometrial scratch compared with treatment as usual in women undergoing their first in vitro fertilisation cycle (the 'Endometrial Scratch Trial') and (2) to undertake a systematic review to combine the results of the Endometrial Scratch Trial with those of previous trials in which endometrial scratch was provided prior to the first in vitro fertilisation cycle.
A pragmatic, multicentre, superiority, open-label, parallel-group, individually randomised controlled trial. Participants were randomised (1 : 1) via a web-based system to receive endometrial scratch or treatment as usual using stratified block randomisation. The systematic review involved searching electronic databases (undertaken in January 2020) and clinicaltrials.gov (undertaken in September 2020) for relevant trials.
Sixteen UK fertility units.
Women aged 18-37 years, inclusive, undergoing their first in vitro fertilisation cycle. The exclusion criteria included severe endometriosis, body mass index ≥ 35 kg/m and previous trauma to the endometrium.
Endometrial scratch was undertaken in the mid-luteal phase of the menstrual cycle prior to in vitro fertilisation, and involved inserting a pipelle into the cavity of the uterus and rotating and withdrawing it three or four times. The endometrial scratch group then received usual in vitro fertilisation treatment. The treatment-as-usual group received usual in vitro fertilisation only.
The primary outcome was live birth after completion of 24 weeks' gestation within 10.5 months of egg collection. Secondary outcomes included implantation, pregnancy, ectopic pregnancy, miscarriage, pain and tolerability of the procedure, adverse events and treatment costs.
One thousand and forty-eight (30.3%) women were randomised to treatment as usual ( = 525) or endometrial scratch ( = 523) and were followed up between July 2016 and October 2019 and included in the intention-to-treat analysis. In the endometrial scratch group, 453 (86.6%) women received the endometrial scratch procedure. A total of 494 (94.1%) women in the treatment-as-usual group and 497 (95.0%) women in the endometrial scratch group underwent in vitro fertilisation. The live birth rate was 37.1% (195/525) in the treatment-as-usual group and 38.6% (202/523) in the endometrial scratch group: an unadjusted absolute difference of 1.5% (95% confidence interval -4.4% to 7.4%; = 0.621). There were no statistically significant differences in secondary outcomes. Safety events were comparable across groups. No neonatal deaths were recorded. The cost per successful live birth was £11.90 per woman (95% confidence interval -£134 to £127). The pooled results of this trial and of eight similar trials found no evidence of a significant effect of endometrial scratch in increasing live birth rate (odds ratio 1.03, 95% confidence interval 0.87 to 1.22).
A sham endometrial scratch procedure was not undertaken, but it is unlikely that doing so would have influenced the results, as objective fertility outcomes were used. A total of 9.2% of women randomised to receive endometrial scratch did not undergo the procedure, which may have slightly diluted the treatment effect.
We found no evidence to support the theory that performing endometrial scratch in the mid-luteal phase in women undergoing their first in vitro fertilisation cycle significantly improves live birth rate, although the procedure was well tolerated and safe. We recommend that endometrial scratch is not undertaken in this population.
This trial is registered as ISRCTN23800982.
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 26, No. 10. See the NIHR Journals Library website for further project information.
体外受精是一种广泛应用的生殖技术，可以在有或没有胞浆内精子注射的情况下进行。子宫内膜搔刮术是体外受精的“附加”程序，有时在第一次体外受精周期前提供，但缺乏支持其使用的证据。
（1）评估子宫内膜搔刮术与常规治疗相比，在接受第一次体外受精周期的女性中的临床有效性、安全性和成本效益（“子宫内膜搔刮试验”），以及（2）进行系统评价，将子宫内膜搔刮试验的结果与之前在第一次体外受精周期前提供子宫内膜搔刮术的试验结果相结合。
一项实用的、多中心、优效性、开放性、平行组、个体随机对照试验。参与者通过基于网络的系统以 1:1 的比例随机分配接受子宫内膜搔刮术或常规治疗，采用分层区组随机化。系统评价包括搜索电子数据库（2020 年 1 月进行）和 clinicaltrials.gov（2020 年 9 月进行）以查找相关试验。
英国的 16 个生育单位。
年龄在 18-37 岁之间的女性，正在接受第一次体外受精周期。排除标准包括严重子宫内膜异位症、体重指数≥35kg/m2 和子宫内膜既往创伤。
子宫内膜搔刮术在月经周期的黄体中期进行，在体外受精前，用 pipelle 插入子宫腔，旋转并抽出三到四次。子宫内膜搔刮组随后接受常规体外受精治疗。常规治疗组仅接受常规体外受精。
主要结局是在取卵后 10.5 个月内完成 24 周妊娠的活产。次要结局包括着床、妊娠、异位妊娠、流产、疼痛和程序的耐受性、不良事件和治疗费用。
1048 名（30.3%）女性被随机分配到常规治疗组（n=525）或子宫内膜搔刮组（n=523），并在 2016 年 7 月至 2019 年 10 月进行了随访，并纳入意向治疗分析。在子宫内膜搔刮组中，453 名（86.6%）女性接受了子宫内膜搔刮术。常规治疗组 494 名（94.1%）和子宫内膜搔刮组 497 名（95.0%）女性均接受了体外受精。常规治疗组的活产率为 37.1%（195/525），子宫内膜搔刮组为 38.6%（202/523）：未调整的绝对差异为 1.5%（95%置信区间 -4.4%至 7.4%； = 0.621）。次要结局无统计学差异。各组的安全事件相当。没有新生儿死亡的记录。每个成功活产的成本为 11.90 英镑（95%置信区间 -134 至 -127）。这项试验和八项类似试验的汇总结果表明，子宫内膜搔刮术并没有增加活产率的显著效果（优势比 1.03，95%置信区间 0.87 至 1.22）。
没有进行假的子宫内膜搔刮术，但这不太可能影响结果，因为使用了客观的生育结果。随机分配接受子宫内膜搔刮术的女性中，有 9.2%的女性没有接受该手术，这可能略微稀释了治疗效果。
我们没有发现证据支持在接受第一次体外受精周期的女性的黄体中期进行子宫内膜搔刮术可以显著提高活产率的理论，尽管该手术耐受性良好且安全。我们建议不在该人群中进行子宫内膜搔刮术。
本试验在英国临床试验注册中心注册，编号为 ISRCTN23800982。
本项目由英国国家卫生研究所（NIHR）卫生技术评估计划资助，全文将在 NIHR 期刊库网站上公布。
