title: Safety and efficacy of a 3 mg dose of the GnRH antagonist cetrorelix in preventing premature LH surges: report of two large multicentre, multinational, phase IIIb clinical experiences.
abstract: Gonadotrophin-releasing hormone antagonists are effective and safe in preventing premature LH surges, a leading cause of cycle cancellation or failure during assisted conception. Two studies assessed two administration regimens for cetrorelix (as Cetrotide): the multiple-dose (MD, 0.25 mg/day, n = 1066) and single-dose (SD, 3 mg, n = 541) protocols. Patient outcomes were very similar: >90% reached criteria for human chorionic gonadotrophin (HCG) administration and underwent oocyte retrieval; embryo transfer was performed in 83-84%; failure to retrieve oocytes was rare (0.8%); on average, 11 follicles > or =10 mm in diameter were seen on the day of HCG administration. The SD protocol was associated with higher numbers of oocytes retrieved and available for insemination, although the numbers of embryos obtained or transferred were comparable. A total of 251 and 121 pregnancies were reported in the MD and SD groups respectively. Pregnancy rates per embryo transfer were 27 and 28% respectively. Severe ovarian hyperstimulation syndrome (OHSS) occurred in <1% of cycles. Twelve per cent of patients reported local reactions to injections in the MD group, compared with 8% in the SD group; none was serious or led to discontinuation. Seventy-three per cent of patients in the SD group received only one injection. These two studies therefore show that the single-dose cetrorelix protocol offers equal efficacy and safety to the MD regimen, while having the advantage of requiring only one injection in most patients.
authors.affiliation: Paris Sud University and Assisted Reproductive Technologies Unit, Hôpital Cochin, Paris, France.
authors.forename: F
authors.initials: F
authors.lastname: Olivennes
authors.forename: K
authors.initials: K
authors.lastname: Diedrich
authors.forename: R
authors.initials: R
authors.lastname: Frydman
authors.forename: R E
authors.initials: RE
authors.lastname: Felberbaum
authors.forename: C M
authors.initials: CM
authors.lastname: Howles
mesh_terms: D000328:Adult; D004334:Drug Administration Schedule; D005260:Female; D007987:Gonadotropin-Releasing Hormone / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives / Q000037:antagonists & inhibitors*; D006727:Hormone Antagonists / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D007279:Injections, Subcutaneous; D007986:Luteinizing Hormone / Q000097:blood*; D016471:Ovarian Hyperstimulation Syndrome / Q000139:chemically induced / Q000503:physiopathology; D011247:Pregnancy; D018873:Pregnancy Rate; D012449:Safety; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D006727:Hormone Antagonists; D007987:Gonadotropin-Releasing Hormone; D007986:Luteinizing Hormone; C062876:cetrorelix