Dreyer K, Lier M C I, Emanuel M H, Twisk J W R, Mol B W J, Schats R, Hompes P G A, Mijatovic V
Department of Reproductive Medicine, VU University Medical Centre, 1081 HZ Amsterdam, The Netherlands
Department of Reproductive Medicine, VU University Medical Centre, 1081 HZ Amsterdam, The Netherlands.
Hum Reprod. 2016 Sep;31(9):2005-16. doi: 10.1093/humrep/dew050. Epub 2016 May 21.
Does hysteroscopic proximal tubal occlusion by intratubal devices as a treatment for hydrosalpinges result in comparable ongoing pregnancy rates following IVF/ICSI when compared with laparoscopic salpingectomy?
Hysteroscopic proximal tubal occlusion by intratubal devices is inferior to laparoscopic salpingectomy in the treatment of hydrosalpinges in women undergoing IVF/ICSI with respect to ongoing pregnancy rates.
It is known that women with hydrosalpinges undergoing IVF have poorer pregnancy outcomes compared with women with other forms of tubal infertility. In these women, both laparoscopic salpingectomy and laparoscopic proximal tubal ligation are known to improve IVF outcomes. At present, it is unclear whether a less-invasive hysteroscopic treatment with intratubal devices leads to similar ongoing pregnancy rates following IVF when compared with laparoscopic salpingectomy.
STUDY DESIGN, SIZE, DURATION: A two-centre, randomized, controlled, non-inferiority trial. Between October 2009 and December 2014 a total of 85 women were included in this study; of whom, 42 were randomized to hysteroscopic proximal occlusion by intratubal device placement and 43 were randomized to laparoscopic salpingectomy. Randomization was based on a computer-generated randomization list. The study was unblinded. The primary outcome was ongoing pregnancy rate, defined as a fetal heartbeat on ultrasound beyond 10-week gestation following one IVF/ICSI treatment (fresh and frozen-thawed embryo transfers).
PARTICIPANTS/MATERIALS, SETTING, METHODS: We studied women aged 18-41 years, with uni- or bilateral ultrasound visible hydrosalpinges who were scheduled for an IVF/ICSI treatment.
The ongoing pregnancy rates per patient according to the intention-to-treat principle were 11/42 (26.2%) after hysteroscopic proximal occlusion by intratubal devices (intervention group) versus 24/43 (55.8%) after laparoscopic salpingectomy (control group) (P = 0.008) [absolute difference: 26.1%; 95% confidence interval (CI): 0.5-51.7, relative risk (RR): 0.56; 95% CI: 0.31-1.03, P = 0.01]. In the per protocol analysis, the ongoing pregnancy rate per patient following hysteroscopic proximal occlusion by intratubal devices was 9/27 (33.3%) compared with 19/32 (59.4%) following laparoscopic salpingectomy (P = 0.067) (absolute difference: 29.6%; 95% CI: 7.1 to 49.1, RR: 0.47; 95% CI: 0.27-0.83, P = 0.062).
LIMITATIONS, REASONS FOR CAUTION: Masking participants and investigators would be difficult due to the nature of both interventions. Since we had objective outcome measurements, we withheld sham procedures, leaving the study unblinded. Furthermore, our low sample size resulted in wide CIs. A larger sample size would result in a more accurate treatment effect; however, this was non-feasible for recruitment and inclusion.
In the treatment of hydrosalpinges prior to IVF/ICSI, hysteroscopic proximal occlusion by intratubal devices is inferior to laparoscopic salpingectomy.
STUDY FUNDING/COMPETING INTERESTS: The intratubal devices were received from Conceptus, Inc., San Carlos, CA, USA, which was acquired by Bayer HealthCare Pharmaceuticals, Inc., Whippany, NJ, USA in 2013. Conceptus, Inc./Bayer HealthCare Pharmaceuticals, Inc. had no role in the study design, data collection and analyses, decision to publish or preparation of the manuscript. The study as a whole was funded by the SWOG (foundation for scientific investigation in obstetrics and gynaecology of the VU University Medical Centre, Amsterdam, the Netherlands). P.G.A.H. has received non-financial support from Conceptus, Inc. during the conduct of this study. He has received grants from Ferring B.V., Merck Serono and Abbott outside the submitted work. M.H.E. has received personal fees from Smith and Nephew and IQ Medical Ventures outside the submitted work.
The Dutch Trial Register: NTR 2073.
October 21, 2009.
DATE OF FIRST PATIENT'S ENROLMENT: October 26, 2009.
对于输卵管积水患者，与腹腔镜输卵管切除术相比，采用输卵管内装置进行宫腔镜近端输卵管阻塞术治疗后，体外受精/卵胞浆内单精子注射（IVF/ICSI）后的持续妊娠率是否相当？
对于接受IVF/ICSI的输卵管积水女性患者，在持续妊娠率方面，采用输卵管内装置进行宫腔镜近端输卵管阻塞术不如腹腔镜输卵管切除术。
已知输卵管积水的女性患者在接受IVF治疗时，其妊娠结局比其他形式输卵管性不孕的女性患者更差。对于这些女性患者，腹腔镜输卵管切除术和腹腔镜近端输卵管结扎术均已知可改善IVF结局。目前尚不清楚，与腹腔镜输卵管切除术相比，采用侵入性较小的输卵管内装置进行宫腔镜治疗后，IVF后的持续妊娠率是否相似。
研究设计、规模、持续时间：一项双中心、随机、对照、非劣效性试验。2009年10月至2014年12月期间，共有85名女性纳入本研究；其中42名被随机分配至通过放置输卵管内装置进行宫腔镜近端阻塞术组，43名被随机分配至腹腔镜输卵管切除术组。随机分组基于计算机生成的随机列表。该研究未设盲。主要结局为持续妊娠率，定义为一次IVF/ICSI治疗（新鲜胚胎移植和冻融胚胎移植）后，超声检查发现妊娠10周后有胎儿心跳。
参与者/材料、环境、方法：我们研究了年龄在18 - 41岁、经超声检查发现单侧或双侧输卵管积水且计划接受IVF/ICSI治疗的女性患者。
根据意向性分析原则，输卵管内装置宫腔镜近端阻塞术组（干预组）每位患者的持续妊娠率为11/42（26.2%），而腹腔镜输卵管切除术组（对照组）为24/43（55.8%）（P = 0.008）[绝对差异：26.1%；95%置信区间（CI）：0.5 - 51.7，相对危险度（RR）：0.56；95% CI：0.31 - 1.03，P = 0.01]。在符合方案分析中，输卵管内装置宫腔镜近端阻塞术组每位患者的持续妊娠率为9/27（33.3%），而腹腔镜输卵管切除术组为19/32（59.4%）（P = 0.067）（绝对差异：29.6%；95% CI：7.1至49.1，RR：0.47；95% CI：0.27 - 0.83，P = 0.062）。
局限性、谨慎原因：由于两种干预措施的性质，对参与者和研究者进行设盲会很困难。由于我们采用客观的结局测量方法，未设置假手术，因此研究未设盲。此外，我们的样本量较小，导致置信区间较宽。更大的样本量将使治疗效果更准确；然而，招募和纳入更多样本不可行。
在IVF/ICSI前治疗输卵管积水时，采用输卵管内装置进行宫腔镜近端阻塞术不如腹腔镜输卵管切除术。
研究资金/利益冲突：输卵管内装置由美国加利福尼亚州圣卡洛斯的Conceptus公司提供，该公司于2013年被美国新泽西州惠普尼的拜耳医疗保健制药公司收购。Conceptus公司/拜耳医疗保健制药公司在研究设计、数据收集与分析、决定发表或稿件准备过程中均未发挥作用。整个研究由SWOG（荷兰阿姆斯特丹VU大学医学中心妇产科科学研究基金会）资助。P.G.A.H.在本研究开展期间接受了Conceptus公司的非资金支持。他在提交的工作之外还接受了Ferring B.V.、默克雪兰诺和雅培公司的资助。M.H.E.在提交的工作之外还接受了施乐辉公司和IQ Medical Ventures公司的个人报酬。
荷兰试验注册库：NTR 2073。
2009年10月21日。
2009年10月26日。
