Ovarian stimulation during assisted reproduction treatment: a comparison of recombinant and highly purified urinary human FSH

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Abstract
This randomized, single-blind, multicentre, multinational study compared recombinant human FSH (rhFSH, Gonal-F®) with highly purified urinary human FSH (uhFSH, Metrodin HP®) in women undergoing ovarian stimulation for IVF/intracytoplasmic sperm injection (ICSI). Following desensitization in a long gonadotrophin-releasing hormone (GnRH) agonist protocol, patients received s.c. Gonal-F® or Metrodin HP®, at a fixed dose of 150 IU, until there was adequate follicular development. Of 496 women randomized, 232 and 231 in the Gonal-F® and Metrodin HP® groups respectively received human chorionic gonadotrophin (HCG). The duration of FSH treatment was significantly shorter with Gonal-F® than with Metrodin HP® (11.6 ± 1.9 days versus 12.4 ± 2.7 days; P < 0.0001) and significantly fewer ampoules were required (mean 22.6 ± 5.0 versus 24.3 ± 5.1, P < 0.0002). There were, however, significantly more follicles ≥10 mm in diameter with Gonal-F® (15.6 ± 8.2 versus 13.6 ± 7.1, P < 0.01) and oocytes retrieved (13.1 ± 7.7 versus 11.4 ± 7.6, P < 0.002). Although no statistical difference in pregnancy rate was recorded, patients receiving Gonal-F® had a higher pregnancy rate per cycle than patients given Metrodin HP® (25.1 versus 20.1%). Moderate to severe ovarian hyperstimulation syndrome occurred in 2.8 and 1.2% of Gonal-F® and Metrodin HP® patients respectively (not significant). In conclusion, FSH stimulation in combination with a long GnRH agonist protocol is effective in inducing multiple follicular development and embryos with a high implantation potential. However, Gonal-F® is clearly more effective than Metrodin HP® in inducing multifollicular development.

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