Comparison of the efficacy and safety of a highly purified human follicle-stimulating hormone (Bravelle™) and recombinant follitropin-β for in vitro fertilization: a prospective, randomized study

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“…This finding, reported in a previous study [8] may be related to the purity of Bravelle ® and the differences in excipients used in the manufacturing processes for the two compounds. For example, Follistim ® contains sodium citrate which has previously been implicated with injection site pain by some [22] while Bravelle ® does not.…”

“…Two randomized, parallel group, clinical trials (one recently published [8]) compared single cycle treatment with subcutaneously administered, purified, human-derived FSH (Bravelle ® ; n = 120) vs. recombinant follitropin-β (Follistim ® ; n = 118) in infertile female patients undergoing IVF. Data were collected from 19 IVF-ET centers, each of which obtained institutional review board approval.…”

Association of rs6166 polymorphism with FSH receptor transcript variants and steroid production in human granulosa cell cultures

“…It is believed that this is determined by individual ovarian sensitivity to gonadotropins, with the size of the ovarian reserve and the effectiveness of the follicular recruitment being of utmost relevance. According to many authors, the type of the gonadotropic preparation as well as the initial and total dose are of secondary importance [Dickey et al 2002;Klinkert et al 2005]. However, there is some scope for drug-induced modulation of multifollicular recruitment and growth, and it seems reasonable to search for predictive factors enabling optimal personalized stimulation.…”

Comparison of the efficacy and safety of a new recombinant human follicle‐stimulating hormone (DA‐3801) with follitropin‐α (Gonal‐F®) in women undergoing controlled ovarian hyperstimulation for assisted reproductive technology

“…Despite the identical amino acid sequences of urine‐derived and recombinant human FSH (rhFSH) preparations, they differ in terms of glycosylation patterns, which are known to influence the isoform profiles of these compounds 3 . The clinical implications of the difference in isoform profiles for FSH products are unclear, and no convincing data is available to indicate the superiority of either urine‐derived or rhFSH formulations for ovarian stimulation in terms of clinical efficacy and safety 4,5 . Compared with urine‐derived gonadotropins, rhFSH preparations have no LH activity, little protein contamination and much less batch‐to‐batch variability.…”