A randomized, single-blind, parallel-controlled and multicentre study: compare the efficacy and safety of domestic and imported human recombinant FSH in WHO group Ⅱ anovulatory infertility

To evaluate the efficacy and safety of domestic human recombinant FSH(rhFSH)in women with anovulation of WHO group Ⅱ. A randomized, blind, parallel-controlled, non-inferiority and multicenter study was performed. A total of 534 admitted to 13 hospitals from May 2008 to August 2009. There were 531 women with ovulatory disorder was included in the statistical analysis, were randomly divided into test group(domestic rhFSH, n=352)and control group(imported rhFSH, n=179). Percentage of cycle with mature follicle, ovulation rate, clinical pregnancy rate, multiple pregnancy rate, ovarian hyperstimulation syndrome(OHSS)and adverse events were observed. No statistical significant differences(P>0.05)were observed between the two groups in terms of the efficiency on mature follicle[91.8%(323/352)versus 88.8%(159/179)], ovulation rate[91.3%(295/323)verus 90.6%(144/159)], clinical pregnancy rate[19.2%(62/323)verus 18.2%(29/159)], the number of the follicles