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

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.

Ned Tijdschr Geneeskd. 2008;152:809-16