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The Legal Network is a free service of North America's leading law firms. Our goal is to keep you better informed about legal issues through channeling the power of law firms into a secure, easy-to-use platform.A recombinant human FSH preparation containing a novel recombinant FSH variant with prolonged half-life.
Recombinant human FSH (r-hFSH) was produced in mammalian cells using a prokaryotic expression system. The FSH preparation was purified by ion-exchange chromatography, gel filtration and re-circulation high-performance liquid chromatography. The FSH content was found to be 4.0% (w/w) in the preparation. The FSH preparation was bio-equivalent to the original one for the ovulation induction in clomiphene citrate (CC)-stimulated patients. The bio-equivalence was examined by repeated ovulation induction in the same individual who received the original or the recombinant preparation. The ovulation rate and the number of dominant follicles were significantly lower in the group receiving the original r-hFSH than in the group treated with the recombinant one. The r-hFSH preparation was compared with the original r-hFSH with regard to the ovarian activity and ovulation rate in a different patient population. The follicular development was assessed by means of ultrasonography and the number of dominant follicles developed in the two groups. The ratio of the number of mature follicles and the numbers of dominant follicles developed in the two groups was similar. The number of dominant follicles was significantly lower and the superovulation rate was significantly higher in the group treated with the original r-hFSH as compared to the group treated with the recombinant one. It is concluded that the FSH activity of the original r-hFSH is somewhat impaired and that the recombinant FSH variant is a promising replacement for the original preparation.
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