A prospective randomized clinical trial comparing an individual dose of recombinant FSH based on predictive factors versus a 'standard' dose of 150 IU/day in 'standard' patients undergoing IVF/ICSI treatment

Abstract
BACKGROUND: The study aim was to compare the use of individual rFSH doses between 100 and 250 IU/day (calculated using the rFSH dose normogram) with a standard dose of rFSH of 150 IU/day. METHODS: This prospective randomized dual‐centre clinical trial included 267 first IVF/ICSI cycles using the long agonist protocol in ‘standard’ patients. Following down‐regulation, 262 patients were randomized using computer‐generated lists using ‘clusters of 10’ into the individual dose (study) group (n = 131) or the standard dose (control) group (n = 131). RESULTS: In the study group, 101 patients (77.1%) had an appropriate response (defined as 5–14 oocytes), compared with 86 (65.6%) in the control group (P < 0.05). Fewer than five oocytes were retrieved in two patients (1.5%) in the study group, compared with 14 patients (10.7%) in the control group (P < 0.05). By comparison, >14 oocytes were retrieved from 27 patients (20.6%) in the study group and from 26 (19.8%) control patients (P = NS). Eighty‐six per cent of the individual dose patients did not require any dose adjustment on day 8, compared with 45% of the standard dose patients (P < 0.01). The ongoing pregnancy rate per initiated cycle was 36.6% in the study group and 24.4% in the control group (P < 0.01). One patient (0.8%) in the study group, and four patients (3.1%) in the control group, were hospitalized due to ovarian hyperstimulation syndrome. CONCLUSIONS: An individual dose regimen in a well‐defined ‘standard’ patient population increased the proportion of appropriate ovarian responses and decreased the need for dose adjustments during controlled ovarian stimulation. A higher ongoing pregnancy rate was observed in the individual dose group.

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