[Reduction of patient discomfort, risks and costs, but not pregnancies, by a mild strategy for in-vitro fertilisation].
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.


METHODS
Randomised, open-label, prospective trial (www.controlledtrials.com, number ISRCTN35766970).


METHODS
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 Euro 8,333.- versus Euro 10,745.- (difference: Euro 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.


CONCLUSIONS
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.
Heijnen
E M E W
EM
Universitair Medisch Centrum Utrecht, afd. Voortplantingsgeneeskunde en Gynaecologie, Utrecht.
Eijkemans
M J C
MJ
de Klerk
C
C
Polinder
S
S
Beckers
N G M
NG
Klinkert
E R
ER
Broekmans
F J
FJ
Passchier
J
J
te Velde
E R
ER
Macklon
N S
NS
Fauser
B C J M
BC