Human Reproduction, Vol. 14, No. 10, 2442-2447,
October 1999
© 1999 European Society of Human Reproduction and Embryology
A prospective, randomized clinical trial comparing 150 IU recombinant follicle stimulating hormone (Puregon®) and 225 IU highly purified urinary follicle stimulating hormone (Metrodin-HP®) in a fixed-dose regimen in women undergoing ovarian stimulation
1 N.V. Organon, PO Box 20, 5340 BH Oss, The Netherlands, 2 University Hospital of Copenhagen (Rigshospitalet), The Fertility Clinic 5021, DK-2100 Copenhagen, Denmark, 3 Isala Clinics – location Sophia, Department of Obstetrics and Gynaecology, Dr C.A.Heesweg 2, 8025 AB Zwolle, The Netherlands and 4 Institut für in Vitro Fertilisierung und Embryo Transfer, Römerstrasse 2, A-6900 Bregenz, Austria
A prospective, randomized, open, multicentre (n = 3) study was conducted to compare the efficacy and efficiency of a fixed daily dose of 150 IU (3x50 IU) recombinant follicle stimulating hormone (recFSH, Puregon®) and 225 IU (3x75 IU) highly purified urinary FSH (uFSH-HP, Metrodin-HP®) in women undergoing ovarian stimulation prior to in-vitro fertilization treatment. A total of 165 women were treated with FSH, 83 subjects with recFSH and 82 subjects with uFSH-HP. In the recFSH group a mean number of 8.8 oocytes were retrieved, compared with 9.8 in the uFSH-HP group (not statistically significant). In the recFSH group, a significantly lower total dose was required compared to the uFSH-HP group, 1479 versus 2139 IU, respectively (P < 0.0001; 95% confidence interval –747 to –572). Treatment with recFSH resulted in a significantly higher embryo development rate (69.6 versus 56.2%; P = 0.003) and more embryos accessible for the embryo freezing programme (3.3 versus 2.0; P = 0.02) compared to uFSH-HP. The vital pregnancy rate per cycle started was 30.2 versus 28.3% in the recombinant and urinary FSH group, respectively. It is concluded that treatment outcome of a fixed daily dose of 150 IU recFSH is comparable to a fixed daily dose of 225 IU uFSH-HP. However, a significantly lower total dose was needed in the recFSH group (nearly 700 IU less).
Key words: IVF/Metrodin-HP®/Puregon®/recombinant FSH/urinary FSH
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