体外受精是一种广泛使用的生殖技术,可以在有或没有卵胞浆内精子注射的情况下进行。子宫内膜划伤程序是体外受精的“附加”,有时在第一个体外受精周期之前提供,但缺乏证据支持其使用。
(1)为了评估临床疗效,与进行首次体外受精周期(“子宫内膜刮伤试验”)的女性常规治疗相比,子宫内膜刮伤的安全性和成本效益比较,(2)进行系统评价,将子宫内膜刮伤试验的结果与先前在首次体外受精周期前提供子宫内膜刮伤的试验结果相结合.
务实,多中心,优越性,开放标签,平行组,个别随机对照试验。参与者通过基于网络的系统进行随机分组(1:1),以接受子宫内膜刮伤或治疗。系统审查涉及搜索电子数据库(于2020年1月进行)和clinicaltrials.gov(于2020年9月进行)进行相关试验。
16个英国生育单位。
18-37岁女性,包容性,正在经历他们的第一个体外受精周期。排除标准包括重度子宫内膜异位症,体重指数≥35kg/m2和先前对子宫内膜的创伤。
在体外受精之前,在月经周期的黄体中期进行子宫内膜刮伤,并涉及将移液管插入子宫腔并旋转并将其抽出三到四次。然后子宫内膜划痕组接受常规体外受精治疗。照常治疗组仅接受常规体外受精。
主要结局是在采卵后10.5个月内完成24周妊娠后的活产。次要结果包括植入,怀孕,异位妊娠,流产,手术的疼痛和耐受性,不良事件和治疗费用。
一千四十八名(30.3%)女性被随机分配接受常规治疗(n=525)或子宫内膜划痕(n=523),并在2016年7月至2019年10月期间进行了随访,并纳入意向治疗分析。在子宫内膜划痕组中,453名(86.6%)妇女接受了子宫内膜刮伤手术。照常治疗组中共有494名(94.1%)妇女和子宫内膜划痕组中的497名(95.0%)妇女进行了体外受精。照常治疗组的活产率为37.1%(195/525),子宫内膜划痕组为38.6%(202/523):未经调整的绝对差异为1.5%(95%置信区间-4.4%至7.4%;p=0.621)。次要结果无统计学差异。安全性事件在各组之间具有可比性。没有新生儿死亡记录。成功活产的成本为每名妇女11.90英镑(95%置信区间-134英镑至127英镑)。该试验和8项类似试验的汇总结果没有发现子宫内膜划痕对增加活产率具有显著影响的证据(比值比1.03,95%置信区间0.87至1.22)。
未进行假子宫内膜刮伤手术,但是这样做不太可能会影响结果,作为使用客观生育结果。总共9.2%随机接受子宫内膜刮伤的女性没有接受手术,这可能稍微稀释了治疗效果。
我们发现没有证据支持这样的理论,即在接受第一次体外受精周期的女性中,在黄体中期进行子宫内膜划伤可以显着提高活产率。尽管该程序耐受性良好且安全。我们建议在该人群中不进行子宫内膜划痕。
本试验注册为ISRCTN23800982。
该项目由国家卫生研究所(NIHR)卫生技术评估计划资助,并将在《卫生技术评估》中全文发表。26号10.有关更多项目信息,请参阅NIHR期刊库网站。
子宫内膜划伤是一个简单的过程,涉及“划伤”子宫内膜(子宫内膜)。一些小型研究表明,在第一个体外受精周期之前进行这项研究可能会提高活产率;然而,其他研究与此相矛盾。进行这项大型研究是为了确认与进行“常规”体外受精治疗的妇女(称为“对照”组)相比,在第一个体外受精周期之前子宫内膜划伤是否会增加活产妇女的数量。我们收集了怀孕的信息,流产,死产,过程中的疼痛和治疗费用,以找出是否有任何有意义的差异。共有1048名年龄介乎18至37岁的妇女被随机分配到两组,所以参与者有50%的机会出现子宫内膜划痕。在整个怀孕期间对妇女进行随访,以确定其体外受精周期的结果。尽管子宫内膜划痕组(38.6%)的活产率比对照组(37.1%)高1.5%,差异不足以显示该手术的任何益处.两组之间的其他结果没有显着差异。然而,该程序是安全和可耐受的。我们发现治疗的费用是,平均而言,接受子宫内膜刮伤组的每位参与者比对照组高316英镑;差异还不足以表明接受子宫内膜刮伤更具成本效益。我们将这项试验的结果与以前的试验结果相结合,这些试验旨在回答类似的问题,发现,总的来说,子宫内膜刮伤手术不会增加活产的机会.我们得出的结论是,首次体外受精前的子宫内膜刮伤并不能改善治疗结果,我们建议在体外受精的第一个周期之前不要进行此程序。
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/m2 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 (n = 525) or endometrial scratch (n = 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%; p = 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 Health Technology Assessment; Vol. 26, No. 10. See the NIHR Journals Library website for further project information.
The endometrial scratch is a simple procedure that involves ‘scratching’ the lining of the womb (the endometrium). Several small studies have shown that undertaking this before the first in vitro fertilisation cycle may improve live birth rates; however, other studies have contradicted this. This large study was carried out to confirm whether or not having an endometrial scratch before the first in vitro fertilisation cycle would increase the number of women having a live birth compared with those having ‘usual’ in vitro fertilisation treatment (known as the ‘control’ group). We collected information about pregnancy, miscarriage, stillbirth, pain during the procedure and costs of treatment to find out if there were any meaningful differences. A total of 1048 women aged between 18 and 37 years were randomly allocated to the two groups, so participants had a 50% chance of having the endometrial scratch. Women were followed up throughout their pregnancy to ascertain the outcome of their in vitro fertilisation cycle. Although the live birth rate was 1.5% higher in the endometrial scratch group (38.6%) than in the control group (37.1%), the difference was not large enough to show any benefit of having the procedure. Other outcomes did not differ significantly between the two groups. However, the procedure was safe and tolerable. We found that the cost of treatment was, on average, £316 per participant higher in the group that received endometrial scratch than in the control group; the difference was not large enough to show that receiving endometrial scratch was more cost-effective. We combined the results of this trial with those of previous trials that looked to answer a similar question, and found that, overall, the endometrial scratch procedure does not enhance the chances of achieving a live birth. We conclude that endometrial scratch before first-time in vitro fertilisation does not improve the outcome of treatment, and we recommend that this procedure is not undertaken prior to a first cycle of in vitro fertilisation.