Human Reproduction, Vol. 15, No. 7, 1490-1498,
July 2000
© 2000 European Society of Human Reproduction and Embryology
Treatment with the gonadotrophin-releasing hormone antagonist ganirelix in women undergoing ovarian stimulation with recombinant follicle stimulating hormone is effective, safe and convenient: results of a controlled, randomized, multicentre trial
A multicentre, open-label, randomized study of the gonadotrophin-releasing hormone (GnRH) antagonist ganirelix (Orgalutran®/AntagonTM) was performed in women undergoing ovarian stimulation with recombinant FSH (rFSH: Puregon®). The study was designed as a non-inferiority study using a long protocol of buserelin (intranasal) and rFSH as a reference treatment. A total of 730 subjects was randomized in a treatment ratio of 2:1 (ganirelix:buserelin) using an interactive voice response system which stratified for age, type of infertility and planned fertilization procedure [IVF or intracytoplasmic sperm injection (ICSI)]. The median duration of GnRH analogue treatment was 5 days in the ganirelix group and 26 days in the buserelin group, whereas the median total rFSH dose was 1500 IU and 1800 IU respectively. In addition, in the ganirelix group the mean duration of stimulation was 1 day shorter. During ganirelix treatment the incidence of LH rises (LH 
10 IU/l) was 2.8% versus 1.3% during rFSH stimulation in the buserelin group. On the day of triggering ovulation by human chorionic gonadotrophin (HCG), the mean number of follicles 11 mm diameter was 10.7 and 11.8, and the median serum oestradiol concentrations were 1190 pg/ml and 1700 pg/ml in the ganirelix and buserelin groups respectively. The mean number of oocytes per retrieval was 9.1 and 10.4 respectively, whereas the mean number of good quality embryos was 3.3 and 3.5 respectively. The fertilization rate was equal in both groups (62.1%), and the same mean number of embryos (2.2) was replaced. The mean implantation rates were 15.7% and 21.8%, and the ongoing pregnancy rates per attempt were 20.3% and 25.7% in the ganirelix and buserelin groups respectively. Evaluation of all safety data indicated that the ganirelix regimen was safe and well tolerated. The overall incidence of ovarian hyperstimulation syndrome was 2.4% in the ganirelix group and 5.9% in the reference group. The results of this study support a safe, short and convenient treatment regimen of ganirelix, resulting in a good clinical outcome for patients undergoing ovarian stimulation for IVF or ICSI.
Key words: buserelin/ganirelix/GnRH agonist/GnRH antagonist/ICSI/IVF/ovarian stimulation/recombinant FSH
1 To whom correspondence should be addressed at: NV Organon, P.O. Box 20, 5340 BH Oss, The Netherlands. E-mail: b.mannaerts{at}organon.oss.akzonobel.nl
* T.Åbyholm (Kvinneklinikken, Rikshospitalet, Oslo, Norway); D.Barlow (John Radcliffe Hospital, Oxford, UK); P.Devroey (Academic Hospital, Free University Brussels, Brussels, Belgium); K.Diedrich (Medizinische Universität zu Lübeck, Lübeck, Germany); J.Donnez (Clinique Universitair Brussels, Belgium); V.von Düring (Regionsykehuset I Trondheim, Trondheim, Norway); B.Fauser (Dijkzigt Academic Hospital, Rotterdam, The Netherlands); L.Hamberger (Sahlgrenska Sjukhuset, Götenborg, Sweden); T.Hillensjö (Fertilitets Centrum, Carlanderska Sjukhuset, Götenborg, Sweden); J.N.Hugues (Hôpital Jean Verdier, Bondy, France); C.Jansen (Diaconessenhuis, Voorburg, The Netherlands); J.Kahn (The Fertility Clinic Ciconia, Copenhagen, Denmark); J.Blaabjerg (Herlev Hospital, Herlev, Denmark); F.Olivennes (Hôpital Antoine Béclère, Clamart, France); A.Pellicer (Instituto Valenciano de Infertilidad, Valencia, Spain); S.Pavlou (Mitera Fertility and IVF Unit, Athens, Greece); T.Rabe (Universitätsklinikum, Heidelberg, Germany); A.Rutherford (Leeds General Infirmary, Leeds, UK); B.Tarlatzis (Infertility IVF Centre `Geniki Cliniki', Thessaloniki, Greece); L.Westergaard (Odense Sygehus, Odense, Denmark); B.Mannaerts and G.Borm (Research and Development, NV Organon, Oss, The Netherlands)
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