目的:子宫输卵管泡沫超声检查(HyFoSy)与子宫输卵管造影术(HSG)相比,不孕妇女在生育检查期间进行输卵管通畅性检查的成本和效果如何?
结论:在生育检查期间,基于HyFoSy的测试结果的临床管理导致略低,虽然没有统计学意义,活产率,以较低的成本,与基于HSG结果的管理相比。
背景:传统上,生育检查期间的输卵管通畅性测试由HSG进行。FOAM审判,正式的非自卑研究,显示,基于HyFoSy结果的管理决策与HSG相比,12个月的活产率具有可比性(46%对47%;差异-1.2%,95%CI:-3.4%至1.5%;P=0.27)。与HSG相比,HyFoSy与显著减少疼痛相关,它缺乏电离辐射和暴露于碘化造影剂。此外,HyFoSy可以由妇科医生在一站式生育检查中进行。据我们所知,这两种策略的成本从未被比较过。
方法:我们与FOAM试验一起进行了经济学评估,在荷兰进行的一项随机多中心研究.参加的不孕妇女,HyFoSy和HSG,以随机顺序。比较了两项测试的结果,并根据其中一项测试的结果将测试结果不一致的妇女随机分配到管理层。随访时间为12个月。
方法:我们研究了计划进行输卵管通畅性检测的1160名不孕妇女(18-41岁)。主要结果是持续怀孕导致活产。经济评估比较了12个月内基于任一测试的管理成本和效果。我们计算了增量成本效益比(ICER):总费用和活产机会的差异。采用意向治疗原则对数据进行分析。
结果:在2015年5月至2019年1月之间,1160名妇女中有1026名接受了输卵管检查,并有可用数据:747名结果一致的妇女(48%的活产),136个结果不确定(40%的活产),结果不一致的143例(41%的患者在根据HyFoSy结果进行管理后有活产,49%的患者在根据HSG结果进行管理后有活产).当比较基于HyfoSy结果与HSG结果的两种策略管理时,HyFoSy后的估计活产机会为46%,HSG后为47%(差异-1.2%;95%CI:-3.4%至1.5%)。对于程序本身,HyFoSy的价格为136欧元,HSG的价格为280欧元。当额外的生育治疗费用被纳入时,HyFoSy策略的平均总成本为3307欧元,HSG策略为3427欧元(平均差-119欧元;95%CI:-125欧元至-114欧元)。所以,虽然HyFoSy降低了每对夫妇的成本,活产率也略低。ICER为10042欧元,这意味着通过使用HyFoSy而不是HSG,我们每损失一次活产将节省10042欧元。
结论:在解释本研究结果时,需要考虑到ICER周围存在相当大的不确定性,并且在这项研究中,由于女性接受了两项输卵管通畅性测试,因此未纳入两项输卵管通畅性测试的直接生育力增强作用。
结论:与基于HSG结果的临床管理相比,在HyFoSy指导下的管理以更低的成本导致了略低的活产率(尽管没有统计学意义),更少的痛苦,没有电离辐射和碘化对比剂暴露。需要进一步研究两种输卵管通畅性测试的直接生育力增强作用的比较。
背景:FOAM试验是一项研究者发起的研究,由ZonMw资助,荷兰卫生研究与发展组织(项目编号837001504)。IQMedicalVentures免费提供ExEm®-FOAM套件。资助者在研究设计中没有作用,收藏,分析,和数据的解释。K.D.报告了Guerbet的旅行和演讲者费用,她的部门在提交的工作之外获得了Guerbet的研究资助。H.R.V.收到了费林的咨询和旅费。A.M.v.P.报告收到了DEKRA的咨询费和Ferring的专家会议费,在提交的工作之外。C.H.d.K.收到了默克公司的差旅费。F.J.M.B.从默克公司获得资助,并从BesinsHealthcare获得演讲者费用。F.J.M.B.是默克和费林顾问委员会的成员。J.v.D.报告了费林的演讲者费用。J.S.报告了与武田和赛诺菲顾问的研究协议,内容涉及提交工作之外的运动MR。M.v.W.获得了牛津出版社的旅行补助金,担任人类生殖副编辑,并以独立的方法学家身份参加了DSMB的产科研究,而她没有其他角色。B.W.M.收到NHMRCGNT1176437的调查员资助。B.W.M.报告ObsEva的顾问,默克,Guerbet,iGenomix,和默克KGaA以及默克KGaA的旅行支持。V.M.从Guerbet获得研究资助,默克,和Ferring以及Guerbet的旅行和演讲者费用。其他作者没有报告利益冲突。
背景:国际临床试验注册平台No.NTR4746。
OBJECTIVE: What are the costs and effects of tubal patency testing by hysterosalpingo-foam sonography (HyFoSy) compared to hysterosalpingography (HSG) in infertile women during the fertility work-up?
CONCLUSIONS: During the fertility work-up, clinical management based on the test results of HyFoSy leads to slightly lower, though not statistically significant, live birth rates, at lower costs, compared to management based on HSG results.
BACKGROUND: Traditionally, tubal patency testing during the fertility work-up is performed by HSG. The FOAM trial, formally a non-inferiority study, showed that management decisions based on the results of HyFoSy resulted in a comparable live birth rate at 12 months compared to HSG (46% versus 47%; difference -1.2%, 95% CI: -3.4% to 1.5%; P = 0.27). Compared to HSG, HyFoSy is associated with significantly less pain, it lacks ionizing radiation and exposure to iodinated contrast medium. Moreover, HyFoSy can be performed by a gynaecologist during a one-stop fertility work-up. To our knowledge, the costs of both strategies have never been compared.
METHODS: We performed an economic evaluation alongside the FOAM trial, a randomized multicenter study conducted in the Netherlands. Participating infertile women underwent, both HyFoSy and HSG, in a randomized order. The results of both tests were compared and women with discordant test results were randomly allocated to management based on the results of one of the tests. The follow-up period was twelve months.
METHODS: We studied 1160 infertile women (18-41 years) scheduled for tubal patency testing. The primary outcome was ongoing pregnancy leading to live birth. The economic evaluation compared costs and effects of management based on either test within 12 months. We calculated incremental cost-effectiveness ratios (ICERs): the difference in total costs and chance of live birth. Data were analyzed using the intention to treat principle.
RESULTS: Between May 2015 and January 2019, 1026 of the 1160 women underwent both tubal tests and had data available: 747 women with concordant results (48% live births), 136 with inconclusive results (40% live births), and 143 with discordant results (41% had a live birth after management based on HyFoSy results versus 49% with live birth after management based on HSG results). When comparing the two strategies-management based on HyfoSy results versus HSG results-the estimated chance of live birth was 46% after HyFoSy versus 47% after HSG (difference -1.2%; 95% CI: -3.4% to 1.5%). For the procedures itself, HyFoSy cost €136 and HSG €280. When costs of additional fertility treatments were incorporated, the mean total costs per couple were €3307 for the HyFoSy strategy and €3427 for the HSG strategy (mean difference €-119; 95% CI: €-125 to €-114). So, while HyFoSy led to lower costs per couple, live birth rates were also slightly lower. The ICER was €10 042, meaning that by using HyFoSy instead of HSG we would save €10 042 per each additional live birth lost.
CONCLUSIONS: When interpreting the results of this study, it needs to be considered that there was a considerable uncertainty around the ICER, and that the direct fertility enhancing effect of both tubal patency tests was not incorporated as women underwent both tubal patency tests in this study.
CONCLUSIONS: Compared to clinical management based on HSG results, management guided by HyFoSy leads to slightly lower live birth rates (though not statistically significant) at lower costs, less pain, without ionizing radiation and iodinated contrast exposure. Further research on the comparison of the direct fertility-enhancing effect of both tubal patency tests is needed.
BACKGROUND: FOAM trial was an investigator-initiated study, funded by ZonMw, a Dutch organization for Health Research and Development (project number 837001504). IQ Medical Ventures provided the ExEm®-FOAM kits free of charge. The funders had no role in study design, collection, analysis, and interpretation of the data. K.D. reports travel-and speakers fees from Guerbet and her department received research grants from Guerbet outside the submitted work. H.R.V. received consulting-and travel fee from Ferring. A.M.v.P. reports received consulting fee from DEKRA and fee for an expert meeting from Ferring, both outside the submitted work. C.H.d.K. received travel fee from Merck. F.J.M.B. received a grant from Merck and speakers fee from Besins Healthcare. F.J.M.B. is a member of the advisory board of Merck and Ferring. J.v.D. reported speakers fee from Ferring. J.S. reports a research agreement with Takeda and consultancy for Sanofi on MR of motility outside the submitted work. M.v.W. received a travel grant from Oxford Press in the role of deputy editor for Human Reproduction and participates in a DSMB as independent methodologist in obstetrics studies in which she has no other role. B.W.M. received an investigator grant from NHMRC GNT1176437. B.W.M. reports consultancy for ObsEva, Merck, Guerbet, iGenomix, and Merck KGaA and travel support from Merck KGaA. V.M. received research grants from Guerbet, Merck, and Ferring and travel and speakers fees from Guerbet. The other authors do not report conflicts of interest.
BACKGROUND: International Clinical Trials Registry Platform No. NTR4746.