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The technical advance of recombinant biotechnology to manufacture FSH has resulted in a biochemically pure FSH preparation with high batch-to-batch consistency. The protein content of recombinant human FSH (r-hFSH) can be reliably quantified in mass units by size exclusion high performance liquid chromatography (SE-HPLC) enabling r-hFSH follitropin alfa (Gonal-F) to be filled and released in the vial on the basis of mass with dose variability of only +/-2% [filled-by-mass (FbM)]. Observational studies have merit in addressing the effectiveness of a new product in routine clinical practice. This non-interventional study assessed r-hFSH follitropin alfa FbM for the multifollicular stimulation of patients undergoing assisted reproduction. A total of 1427 patients were recruited in 21 centres in the UK and the mean age was 34.3 years (+/-4.48, range 18-48). Of those who started treatment, 1388 (97.3%) received human chorionic gonadotrophin and 1330 (93.2%) underwent oocyte retrieval. A total of 1213 (85%) patients had embryo transfer and in the majority of recorded cases, most embryos replaced were graded as 1 or 2 (74.6%). The ongoing clinical pregnancy rate was 29.2% per cycle and 34.4% per embryo transfer. The routine use of r-hFSH follitropin alfa FbM in normal clinical practice in IVF has been demonstrated to be effective, safe and well received by patients.

Type

Journal article

Journal

Reprod Biomed Online

Publication Date

12/2004

Volume

9

Pages

604 - 610

Keywords

Adult, Chorionic Gonadotropin, Female, Fertilization in Vitro, Follicle Stimulating Hormone, Human, Humans, Infertility, Female, Middle Aged, Ovarian Follicle, Ovulation Induction, Pregnancy, Pregnancy Rate, Prospective Studies, Recombinant Proteins