OBJECTIVE: To compare the efficacy and safety of 250 microg and 500 microg 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 ninety-seven ovulatory infertile women undergoing a single cycle of assisted reproduction technology. INTERVENTION(S): Patients were randomized 1:1:1 to 250 microg of recombinant hCG SC, 500 microg 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 microg of recombinant hCG, 500 microg 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 microg 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 microg) SC is equivalent to 10,000 U USP of urinary hCG in this indication.
RCT Entities:
OBJECTIVE: To compare the efficacy and safety of 250 microg and 500 microg 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 ninety-seven ovulatory infertile women undergoing a single cycle of assisted reproduction technology. INTERVENTION(S): Patients were randomized 1:1:1 to 250 microg of recombinant hCG SC, 500 microg 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 microg of recombinant hCG, 500 microg 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 microg 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 microg) SC is equivalent to 10,000 U USP of urinary hCG in this indication.
Authors: R Matorras; A Meabe; R Mendoza; B Prieto; O Ramón; J Mugica; F Aspichueta; A Exposito Journal: J Assist Reprod Genet Date: 2012-07-20 Impact factor: 3.412
Authors: Judith A F Huirne; Cornelis B Lambalk; Andre C D van Loenen; Roel Schats; Peter G A Hompes; Bart C J M Fauser; Nick S Macklon Journal: Drugs Date: 2004 Impact factor: 9.546
Authors: Divya K Shah; Stacey A Missmer; Katharine F B Correia; Elizabeth S Ginsburg Journal: J Clin Endocrinol Metab Date: 2014-01-29 Impact factor: 5.958