PURPOSE: To compare the efficacy of clomiphene citrate (CC) and recombinant FSH (rFSH) protocols in ovarian stimulation (OS)/intrauterine insemination (IUI) cycles for couples with unexplained infertility or male subfertility. METHODS:One hundred and eighty-nine patients with unexplained or male subfertility were randomized to treatment with 100 mg/day CC for 5 days (93 patients) or rFSH with starting dose of 75-100 IU daily (96 patients). The main outcome measurement was ongoing pregnancy rate (OPR). RESULTS: The number of preovulatory (≥ 17 mm) follicles on the day of hCG administration was significantly greater in the rFSH group than in the CC group (1.7 vs. 1.4, P = .01). Multifollicular growth was observed in 35.1% in the CC group and 54.8% in the FSH group (P = .01). The OPR per cycle was 9.6 and 15.6% for CC and rFSH groups, respectively (P = .31). CONCLUSIONS:Recombinant FSH is superior to CC for enabling multifollicular development in OS/IUI cycles of unexplained and male subfertile couples. Although this finding did not lead to a statistically significant superiority of rFSH in terms of clinical outcomes, the presence of relative increase by 62.5% in OPR with rFSH may be regarded as a clinically significant trend.
RCT Entities:
PURPOSE: To compare the efficacy of clomiphene citrate (CC) and recombinant FSH (rFSH) protocols in ovarian stimulation (OS)/intrauterine insemination (IUI) cycles for couples with unexplained infertility or male subfertility. METHODS: One hundred and eighty-nine patients with unexplained or male subfertility were randomized to treatment with 100 mg/day CC for 5 days (93 patients) or rFSH with starting dose of 75-100 IU daily (96 patients). The main outcome measurement was ongoing pregnancy rate (OPR). RESULTS: The number of preovulatory (≥ 17 mm) follicles on the day of hCG administration was significantly greater in the rFSH group than in the CC group (1.7 vs. 1.4, P = .01). Multifollicular growth was observed in 35.1% in the CC group and 54.8% in the FSH group (P = .01). The OPR per cycle was 9.6 and 15.6% for CC and rFSH groups, respectively (P = .31). CONCLUSIONS: Recombinant FSH is superior to CC for enabling multifollicular development in OS/IUI cycles of unexplained and male subfertile couples. Although this finding did not lead to a statistically significant superiority of rFSH in terms of clinical outcomes, the presence of relative increase by 62.5% in OPR with rFSH may be regarded as a clinically significant trend.
Authors: Irene Souter; Fangbai Sun; Heping Zhang; Michael P Diamond; Richard S Legro; Robert A Wild; Karl R Hansen; Nanette Santoro Journal: Fertil Steril Date: 2022-02 Impact factor: 7.329
Authors: Karl R Hansen; Esther Eisenberg; Valerie Baker; Micah J Hill; Sixia Chen; Sara Talken; Michael P Diamond; Richard S Legro; Christos Coutifaris; Ruben Alvero; Randal D Robinson; Peter Casson; Gregory M Christman; Nanette Santoro; Heping Zhang; Robert A Wild Journal: J Clin Endocrinol Metab Date: 2018-07-01 Impact factor: 5.958
Authors: Karl R Hansen; Jennifer D Peck; R Matthew Coward; Robert A Wild; J C Trussell; Stephen A Krawetz; Michael P Diamond; Richard S Legro; Christos Coutifaris; Ruben Alvero; Randal D Robinson; Peter Casson; Gregory M Christman; Nanette Santoro; Heping Zhang Journal: Hum Reprod Date: 2020-06-01 Impact factor: 6.353