47486
document
Pharmacokinetics and follicular dynamics of corifollitropin alfa versus recombinant FSH during ovarian stimulation for IVF . A single injection of corifollitropin alfa can replace seven daily injections of recombinant FSH ( rFSH ) using a gonadotrophin-releasing hormone antagonist protocol in ovarian stimulation prior to IVF or intracytoplasmic sperm injection . This double-blind randomized controlled trial assessed the pharmacokinetics and pharmacodynamics of 150μg corifollitropin alfa versus daily 200IU rFSH in 1509 patients . Comparative analyses were performed on serum concentrations of FSH immunoreactivity ( pharmacokinetics ) , and the number and size of growing follicles , and inhibin B and oestradiol concentrations as biomarkers of ovarian response ( pharmacodynamics ) . The rate of follicular development was similar in both treatment groups . By stimulation day 8 , 33 % of patients treated with corifollitropin alfa reached the criterion for human chorionic gonadotrophin ( HCG ) injection . The number of follicles ⩾11mm was slightly higher after corifollitropin alfa compared with daily rFSH at stimulation day 8 ( difference , 1.2 ; 95 % confidence interval ( CI ) 0.5-1.8 ; P < 0.01 ) and on the day of HCG injection ( difference , 2.1 ; 95 % CI 1.4-2.8 ; P < 0.01 ) . The rise of inhibin B and oestradiol concentrations was similar in both treatment groups . Although the pharmacokinetics of corifollitropin alfa and rFSH are quite different their pharmacodynamic profiles at the dosages used are similar . A single injection of corifollitropin alfa can replace seven daily injections of recombinant FSH ( rFSH ) using a gonadotrophin-releasing hormone antagonist protocol in ovarian stimulation prior to IVF or intracytoplasmic sperm injection . The objective of this study was to compare the pharmacokinetics and pharmacodynamics of corifollitropin alfa versus daily rFSH . A total of 1509 patients were randomized in a double-blind , controlled trial to either a single injection of 150μg corifollitropin alfa or to daily injections of 200IU rFSH for the first 7 days of ovarian stimulation . Serum levels of FSH immunoreactivity were analysed ( pharmacokinetic analysis ) , together with the number and size of growing follicles and serum inhibin B and oestradiol concentrations as biomarkers of the ovarian response ( pharmacodynamic analysis ) . Serum FSH immunoreactivity levels were higher up to stimulation day 5 for corifollitropin alfa compared with the daily rFSH regimen but were similar from day 8 onwards , when patients started rFSH if the criteria for human chorionic gonadotrophin were not yet reached . Corifollitropin alfa treatment resulted in a similar growth rate of follicles though a slightly higher number of follicles were recruited compared with daily rFSH . It is concluded that the pharmacokinetics of corifollitropin alfa and rFSH are quite different but their induced pharmacodynamic effects at the dosages used are similar .
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Intervention_Pharmacological
corifollitropin alfa
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Intervention_Pharmacological
recombinant FSH
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Intervention_Pharmacological
corifollitropin alfa
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Intervention_Pharmacological
recombinant FSH ( rFSH )
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Outcome_Physical
rate of follicular development
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Outcome_Physical
number of follicles ⩾11mm
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Outcome_Physical
rise of inhibin B
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Outcome_Physical
oestradiol concentrations
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Outcome_Physical
Serum FSH immunoreactivity levels
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Participant_Condition
ovarian stimulation for IVF .