A prospective randomized clinical trial of differing starter doses of recombinant follicle-stimulating hormone (follitropin-beta) for first time in vitro fertilization and intracytoplasmic sperm injection treatment cycles.

OBJECTIVE: Comparison of the efficacy of differing starter doses of recombinant follicle stimulating hormone (rFSH) for IVF and intracytoplasmic sperm injection cycles when the treatment is administered both subcutaneously and intramuscularly.

DESIGN: Single center 1-year prospective randomized study.

SETTING: Academic teaching hospital.

PATIENT(S): 345 couples in first cycle.

INTERVENTION(S): Treatment with subcutaneous or intramuscular rFSH, followed by E(2) and ultrasound follicle tracking, with later oocyte collection and zygote transfer.

MAIN OUTCOME MEASURE(S): Ovarian response and other clinically dependent variables.

RESULT(S): Group 1 patients, with day-3 FSH levels of less than 8.5 U/L, were randomized to begin treatment with rFSH at 150 IU (n = 146) or 200 IU (n = 151). The total dose of the drugs used was significantly lower in 150 IU group, as was the number of ICSI metaphase II oocytes. No other significant differences found. The dosage was increased in 9% on day 5. Group 2 patients, with day-3 FSH levels of greater than 8.5 U/L, were randomized to treatment with rFSH at 300 IU (n = 24) or 400 IU (n = 24). No significant outcome differences found between the two subgroups. Pregnancy rates for this group were half that of Group 1.Intramuscular administration was significantly more likely to result in a need for increased dosage than was subcutaneous administration. The level of E(2) at the time of hCG treatment was significantly lower in the intramuscular 150 IU group.

CONCLUSION(S): In the main study total dosage used, the ICSI metaphase II oocyte numbers were significantly lower and there was a trend toward a need for a dosage increase on day 5 when 150 IU rFSH was the starter dosage, as compared to a starting dosage of 200 IU. Otherwise, there is little advantage to using the higher dosage.