Objective: To determine the effects of ovarian stimulation with highly purified urofollitropin on oocyte and embryo quality.
Design: Parallel randomized open-label clinical study.
Setting: Assisted reproduction centers.
Patient(s): Two hundred sixty-seven infertile couples undergoing IVF/ICSI.
Intervention(s): All participants underwent standard down-regulation with GnRH analogue. One hundred thirty-three participants received highly purified urinary FSH and 134 controls received recombinant FSH.
Main outcome measure(s): Primary end points were number of morphologically mature oocytes retrieved, embryo quality, and pregnancy and implantation rates. Secondary end points were: total number of days of FSH stimulation, total dose of gonadotropin administered, fertilization rate per number of retrieved oocytes, embryo cleavage rate, live birth and miscarriage rates, endometrial thickness and estradiol level on the day of hCG administration, cancellation rate, and incidence of moderate or severe ovarian hyperstimulation syndrome.
Result(s): Pregnancy and implantation rates were nonsignificantly higher in the urinary FSH group than the recombinant FSH group (46.5% vs. 36.8% and 22.1% vs. 15.8%, respectively). The grade 1 embryo score was significantly higher in the urinary FSH group than the recombinant FSH (42.1% vs. 33.5%), and the live birth rate was nonsignificantly higher in the former group.
Conclusion(s): Highly purified urinary FSH is as effective, efficient, and safe for clinical use as recombinant FSH.