Minder risico's, patiëntenongemak en kosten, maar niet minder zwangerschappen in de milde behandelstrategie voor ivf

E. M.E.W. Heijnen, M. J.C. Eijkemans, C. De Klerk, S. Polinder, N. G.M. Beckers, E. R. Klinkert, F. J. Broekmans, J. Passchier, E. R. Te Velde, N. S. Macklon, B. C.J.M. Fauser

    Publikation: Bidrag til tidsskriftArtikelForskningpeer review

    Abstrakt

    Objective. To compare a so-called mild in-vitro fertilisation (IVF) treatment strategy with the standard IVF treatment on the following aspects: the chance of a pregnancy resulting in full-term live birth within 1 year, patient discomfort, multiple pregnancies, and costs. Design. Randomised, open-label, prospective trial (www.controlled-trials.com, number ISRCTN35766970). Method. 404 patients were assigned to undergo either a mild treatment, consisting of ovarian stimulation with a gonadotrophin releasing hormone (GnRH) antagonist combined with single embryo transfer, or the standard treatment consisting of prolonged stimulation with a GnRH agonist combined with the transfer of two embryos. The primary outcome measures were: (1) the percentage of cumulative pregnancies within one year after randomisation leading to full-term live birth; (2) total costs per couple and child up to 6 weeks after expected delivery; and (3) overall patient discomfort. Analysis was done according to the intention-to-treat principle and was intended to show that the mild treatment was not inferior to the standard treatment; the non-inferiority threshold was -12.5%. Results. The proportion of cumulative pregnancies resulting in full-term live birth after 1 year was 43.4% in the mild and 44.7% in the standard treatment group. The lower limit of the one-sided 95% confidence interval was equal to -9.8%. The respective proportion of couples with multiple pregnancies was 0.5% versus 13.1% (p < 0.0001), and the average total costs were € 8,333.- versus € 10,745.- (difference: € 2,412.-, 95% CI: 703-4,131). There were no statistically significant differences between the groups with regard to anxiety, depression, physical discomfort, and sleep quality. Conclusion. After 1 year of treatment, the cumulative percentage of pregnancies leading to full-term live birth and the total patient discomfort were the same for the mild treatment (average 2.3 IVF-cycles) and the standard treatment (average 1.7 IVF-cycles). The mild treatment significantly reduced the number of multiple pregnancies and the overall costs.

    Bidragets oversatte titelReduction of patient discomfort, risks and costs, but not pregnancies, by a mild strategy for in-vitro fertilisation
    OriginalsprogNederlandsk
    Sider (fra-til)809-816
    Antal sider8
    TidsskriftNederlands Tijdschrift voor Geneeskunde
    Vol/bind152
    Udgave nummer14
    StatusUdgivet - 5 apr. 2008

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