Hum. Reprod. Advance Access published online on April 20, 2007
Human Reproduction, doi:10.1093/humrep/dem075
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Highly purified FSH is as efficacious as recombinant FSH for ovulation induction in women with WHO Group II anovulatory infertility: a randomized controlled non-inferiority trial
1 Leeds General Infirmary, Department of Obstetrics and Gynaecology, Clarendon Wing, Leeds General Infirmary, Belmont Grove, Leeds LS2 9NS, UK 2 Center for Reproductive Medicine of the Vrije Universiteit Brussel (VUB), Brussels, Belgium 3 Rigshospitalet, Fertility Clinic, Copenhagen, Denmark 4 Ferring Pharmaceuticals A/S, Obstetrics and Gynaecology, Clinical Research and Development, Copenhagen, Denmark
5 Correspondence address. Tel: +44-113-392-2728; Fax: +44-113-392-2446; E-mail: adam.balen{at}leedsth.nhs.uk
BACKGROUND: The objective of this study was to demonstrate non-inferiority of a highly purified urinary follicle stimulating hormone (HP-FSH) preparation compared with a recombinant (rFSH) preparation with respect to ovulation rate (primary end-point).
METHODS: This was a randomized, open-label, assessor-blind, multinational study. Women with anovulatory infertility WHO Group II and resistant to clomiphene citrate were randomized (computer-generated list) to stimulation with HP-FSH (n = 73) or rFSH (n = 78) using a low-dose step-up protocol. The non-inferiority limit was prespecified at –20%.
RESULTS: The ovulation rate was 85.2% (51/62) with HP-FSH and 90.9% (60/66) with rFSH (per-protocol population), and non-inferiority was demonstrated [95% confidence interval: –16.9; 5.6]. No differences were noted between groups in number of follicles 
12 mm, 15 mm or 18 mm, mono-follicular development, pregnancy rates, endometrial thickness, number of ovarian stimulation syndrome cases or frequency of injection site reactions/pain. The singleton live birth rate was 15% in both groups (11/73 with HP-FSH and 12/78 with rFSH).
CONCLUSIONS: This urinary HP-FSH preparation is non-inferior compared with a rFSH preparation with respect to ovulation rate in anovulatory WHO Group II women failing to ovulate or conceive on clomiphene citrate.
Key words: highly purified FSH/ovulation induction/polycystic ovary syndrome/recombinant FSH
Submitted on September 29, 2006; resubmitted on February 15, 2005; accepted on February 28, 2007.
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