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This is an open-label, Phase 3, randomized, two arms, multicenter, prospective, experimental study of Folitime® (a new biosimilar formulation of r-hFSH, follitropin alfa) versus the original one (Gonal-f ®).
Full description
Follitropin alfa is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, nonidentical glycoproteins designated as the alfa- and beta-subunits. Similar to other glycoprotein hormones, FSH has a high degree of heterogeneity due to differences in the amount and/or composition of the carbohydrate residues, particularly sialic acid. FSH, the active component of r-hFSH is the most important hormone responsible for follicular recruitment and development. In order to obtain final maturation of the follicle and ovulation in the absence of an endogenous LH surge, human chorionic gonadotropin (hCG) must be given following the administration of r-hFSH when monitoring of the patient indicates that sufficient follicular development has occurred.
Secondary endpoints to be measured by the study are
Efficacy
Safety
Incidence of
Tolerability
Immunogenicity Measurement of possible antibodies against exogenous r-hFSH will be evaluated. Pharmacodynamics
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106 participants in 2 patient groups
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Data sourced from clinicaltrials.gov
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