P-518: Effect of LBFS0101, a new recombinant follicle-stimulating hormone, in human in vitro fertilization and embryo transfer program: A prospective and randomized clinical study

Abstract

The purpose of this study was to analyze the efficacy and tolerability of follitropin-heterodimeric alpha-beta subunit mixture (LBFS0101; LG Life Sciences Ltd., Seoul, South Korea), new recombinant human FSH (r-hFSH) preparations, for superovulation in patients undergoing IVF-ET. Randomized, parallel-group, open, multi-center clinical study. One hundred and three infertile women undergoing IVF-ET in 2005 were entered into the study under approval of the Institutional Reviewer Board. After down-regulation with buserelin acetate, patients were randomized to receive LBFS0101 (n=52) or Gonal-F (Serono Inc., Geneva, Switzerland, n=51). r-hFSH was administrated at 150-300 IU/d for 3∼5 days, and then dosages were adjusted according to the ovarian response. Ovarian stimulation characteristics, ovum retrieval, and IVF/ICSI outcomes were compared. Total of 15 cycles were cancelled, 88 cycles (LBFS0101 = 47 cycles; Gonal F = 41 cycles) were studied. There were no statistically significant differences in any clinical profiles of patients between the two preparations. Also, cumulative dose of r-hFSH (2371.3 ± 728.4 mIU for LBFS0101 vs.2409.8 ± 769.4 mIU for Gonal F), duration of r-hFSH treatment (9.3 ± 2.0 days vs. 9.3 ± 1.8 days), number of follicles of ≥ 14 mm on the of hCG injection (9.3 ± 4.6 days vs. 10.6 ± 5.8), and number of retrieved oocytes (14.2 ± 9.1 vs. 14.4 ± 8.8) were not different. Clinical pregnancy rate and implantation rates were similar (44.7% (21/47), 22.1% (38/169) for LBFS0101 and 56.1% (23/41), 29.5% (41/139) for Gonal F). Anti-FSH antibody was not detected in all samples. The results of this clinical study indicate that LBFS0101 may be suitable for use in ovarian stimulation for human IVF-ET program.