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

Author(s): Wilcox J, Potter D, Moore M, Ferrande L, Kelly E, CAP IV Investigator Group

Affiliation(s): Huntington Reproductive Center, Pasadena, California, USA.

Publication date & source: 2005-07, Fertil Steril., 84(1):108-17.

Publication type: Clinical Trial, Phase IV; Multicenter Study; Randomized Controlled Trial

OBJECTIVE: To compare the safety and efficacy of single-dose cetrorelix acetate (3 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 (3 mg SC) or daily dose of ganirelix (0.25 mg SC) was administered when the lead follicle was > or =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.

Page last updated: 2006-01-31

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