Cetrorelix in an oral contraceptive-pretreated stimulation cycle compared with buserelin in IVF/ICSI patients treated with r-hFSH: a randomized, multicentre, phase IIIb study.

Abstract

BACKGROUND: The aim of this study was to assess the non-inferiority of an oral contraceptive (OC)-pretreated cetrorelix regimen and a buserelin regimen in IVF/ICSI patients treated with r-hFSH in terms of total number of oocytes retrieved. METHODS: Multicentre, randomized study. One hundred and eighty two patients were randomized to receive cetrorelix with OC pretreatment (n = 91) or to receive buserelin (n = 91). The cetrorelix group started with daily OCs on cycle day 5 and continued for 21-28 days. Cetrorelix (0.25 mg) was given daily from stimulation day 6 up to and including the day of r-hCG administration. The buserelin group started with buserelin (500 microg/day) for at least 10 days until down-regulation was achieved, after which the dose was reduced to daily 200 microg up to and including the day of r-hCG administration. r-hFSH was started in both groups on a Friday, in the cetrorelix group 5 days after the last OC pill intake. Both regimens were followed by a standard IVF or ICSI procedure. The primary efficacy endpoint was the number of oocytes retrieved per patient. RESULTS: Number of oocytes, cancellation rates, r-hFSH requirements, number of oocyte retrievals during the weekend or public holiday and number of pregnancies were similar in both groups. Both treatment regimens were well tolerated. CONCLUSIONS: Cetrorelix pretreated with OCs resulted in similar number of oocytes retrieved compared with a long buserelin protocol. Both regimens were well tolerated and allowed scheduling of the oocyte retrieval, with only small number of retrievals falling on a weekend or public holiday.