Quantification of Follicle Stimulating Hormone (follitropin alfa): Is In Vivo Bioassay Still Relevant in the Recombinant Age?

R. Driebergen, G. Baer


Curr Med Res Opin. 2003;19(1) 

In This Article

Clinical Implications of Gonal-F FbM

In a clinical study,[6] four batches of Gonal-F were each filled by bioassay, as well as by mass. When comparing the clinical response of these batches, those patients receiving the filled-by-mass preparation had a more consistent clinical response in terms of oocytes retrieved. Greater control of the dose of FSH delivered is therefore associated with an improved consistency of clinical response. Initial clinical experience in women undergoing COS for ART indicates that Gonal-F FbM is more effective than standard filled-by-bioassay Gonal-F in terms of the quantity and quality of oocytes and embryos, number of days of stimulation and number of doses required.[7] Gonal-F FbM is, of course, also at least as well tolerated as the standard Gonal-F product.[7,8] Further studies using the novel FbM product are ongoing.


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