Recombinant human chorionic gonadotropin (rhCG) in assisted reproductive technology:: Results of a clinical trial comparing two doses of rhCG (Ovidrel®) to urinary hCG (Profasi®) for induction of final follicular maturation in in vitro fertilization-embryo transfer

Objective: To compare the efficacy and safety of 250 mug and 500 mug of recombinant hCG with 10,000 U USP of urinary hCG in assisted reproduction technology. Design: Open, comparative, randomized, prospective clinical study. Setting: Twenty tertiary care U.S. infertility centers. Patient(s): Two hundred ninty-seven ovulatory infertile women undergoing a single cycle of assisted reproduction technology. Intervention(s): Patients were randomized 1:1:1 to 250 mug of recombinant hCG SC, 500 mug of recombinant hCG SC, or 10,000 U USP urinary hCG IM after completing gonadotropin stimulation. Main Outcome Measure(s): Number of oocytes retrieved per patient receiving hCG. Also, measures of oocyte maturity, embryo development, and luteal function, as well as pregnancy and pregnancy outcome. Adverse safety events, laboratory changes, local tolerance, and immunogenicity were also assessed. Result(s): Mean numbers of oocytes retrieved per treatment group were equivalent, 13.6, 14.6, and 13.7 with 250 mug of recombinant hCG, 500 mug of recombinant hCG, and urinary hCG, respectively. The numbers of 2PN fertilized oocytes on day 1 after oocyte retrieval, and 2PN or cleaved embryos on the day of embryo transfer, were significantly higher with 500 mug of recombinant hCG than with the lower dose. However, the incidence of adverse events also tended to be higher with this dose. Conclusion(s): Recombinant hCG is effective and well tolerated in the induction of final follicular maturation and luteinization in women undergoing assisted reproduction technology. Recombinant hCG (250 mug) SC is equivalent to 10,000 U USP of urinary hCG in this indication. (C) 2001 by American Society for Reproductive Medicine.