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.
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.
Popovic-Todorovic
B
B
The Fertility Clinic 4071, Rigshospitalet, Copenhagen and The Fertility Clinic, Hvidovre Hospital, Hvidovre, Denmark. drbiba@yahoo.com
Loft
A
A
Bredkjaeer
H Ejdrup
HE
Bangsbøll
S
S
Nielsen
I K
IK
Andersen
A Nyboe
AN
D000328:Adult; D004305:Dose-Response Relationship, Drug; D005260:Female; D005307:Fertilization in Vitro; D005640:Follicle Stimulating Hormone / Q000008:administration & dosage*; D006801:Humans; D011247:Pregnancy; D018873:Pregnancy Rate; D011379:Prognosis; D011994:Recombinant Proteins / Q000008:administration & dosage; D020554:Sperm Injections, Intracytoplasmic
D011994:Recombinant Proteins; D005640:Follicle Stimulating Hormone