| Abstract: | This multicentre, double-blind, double-dummy, randomized, parallel-groupstudy compared the efficacy and safety of recombinant humanchorionic gonadotrophin (rHCG) (Ovidrel®) and urinary HCG(uHCG) (Profasi®) for inducing final follicular maturationand early luteinization in women undergoing ovulation inductionfor assisted reproduction treatment. Following long down-regulationand stimulation with recombinant human FSH (rFSH) (Gonal-F®),a total of 190 women received a single, s.c. injection of either250 µg rHCG or 5000 IU uHCG. For evaluable patients (n= 172), the mean number of oocytes retrieved per patient (primaryefficacy endpoint) was 11.6 for rHCG and 10.6 for uHCG (notsignificant). The mean number of mature oocytes was statisticallyhigher (P = 0.027) for the rHCG group than the uHCG (9.4 versus7.1). Serum progesterone concentrations on day 1 and days 6–7post-HCG, and serum HCG concentrations at all post-HCG timepoints were statistically significantly in favour of rHCG. Theclinical pregnancy rate was somewhat higher (not significant)in the rHCG group (33 versus 25%) as was the live birth rate(27 versus 23%, not significant). Both treatments were welltolerated, though the incidence of adverse events was significantlyhigher in the uHCG group (45.1 versus 22.7%, P = 0.0004). Theincidence of injection-site reactions was significantly lowerin the rHCG group (P = 0.0001). In conclusion, for triggeringovulation, rHCG seems to have significant advantages comparedwith uHCG in terms of number of mature oocytes retrieved, lutealprogesterone and local tolerance. |
