A double-blind clinical trial comparing a fixed daily dose of 150 and 250 IU of recombinant follicle-stimulating hormone in women undergoing in vitro fertilization.

OBJECTIVE To determine the efficacy and efficiency of two fixed doses of recombinant follicle-stimulating hormone (FSH) in controlled ovarian hyperstimulation. DESIGN Randomized, double-blind clinical trial. SETTING Fifteen IVF clinics in Argentina, Brazil, Chile, Colombia, Mexico, and Venezuela. PATIENT(S) Women between 30 and 39 years of age undergoing IVF or intracytoplasmic sperm injection (ICSI). INTERVENTION(S) Daily doses of either 150 IU or 250 IU of recombinant FSH (Puregon) until at least two follicles >or=20 mm were seen on ultrasound. MAIN OUTCOME MEASURE(S) Number of cumulus-oocyte complexes retrieved and total dose of recombinant FSH used. RESULT(S) Two hundred one women received 150 IU and 203 used 250 IU. In the low-dose group 8.9 oocytes were retrieved compared to 10.2 in the high-dose group (not significant). The 150 IU-treated women received a total of 1,589 IU and the total dose used in 250 IU treated women was 2,492 IU. Implantation rates were 10.0% in the 150 IU group and 10.9% in the 250 IU group. The vital pregnancy rates per started cycle in the low-dose and high-dose groups were 17.1% and 16.7%, respectively. Two women, both in the 250 IU group, were hospitalized because of the ovarian hyperstimulation syndrome (OHSS). CONCLUSION(S) An increase from 150 IU to 250 IU daily dose of recombinant FSH in women between 30 and 39 years of age has only limited value in augmenting ovarian response.