Prospective, randomized trial comparing cetrorelix acetate and ganirelix acetate in a programmed, flexible protocol for premature luteinizing hormone surge prevention in assisted reproductive technologies

Objective: To compare the safety and efficacy of single-dose cetrorelix acetate Q mg) and daily ganirelix acetate (0.25 mg) in the inhibition of premature LH surge in women undergoing cycle-programmed ovarian stimulation before Assisted Reproductive Technology (ART). Design: Prospective, open-label, randomized, comparative study. Setting: Sixteen ART centers in the United States. Patient(s): One hundred eighty-five infertile patients undergoing ART. Intervention(s): Single injection of cetrorelix (025 mg SC) or daily dose of ganirelix (0.25 mg SQ was administered when the lead follicle was >= 14 mm. Daily cetrorelix (0.25 mg) was administered if the criteria for hCG administration were not met 4 days after receiving 3 mg of cetrorelix. Main Outcome Measure(s): Percentage of patients who did not have a premature LH surge, defined as LH < 10 IU/L on the day of hCG administration. The IVF and embryo transfer (ET) outcomes were assessed. Result(s): No patient in either treatment group had a premature LH surge. There were no statistically significant differences between treatments for any IVF/intracytoplasmic sperm injection (ICSI) or ET outcomes, including pregnancy rate (PR). However, cetrorelix required significantly fewer injections than ganirelix. Similar safety profiles were observed. Conclusion(s): Cetrorelix and ganirelix effectively prevented LH surges in oral contraceptive (OC) pill-programmed, flexible protocols, with similar safety profiles and PRs; however, cetrorelix required significantly fewer injections, increasing patient convenience. (c) 2005 by American Society for Reproductive Medicine.