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.
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>or=12 mm, >or=15 mm or >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.
Balen
Adam
A
Leeds General Infirmary, Department of Obstetrics and Gynaecology, Belmont Grove, Leeds LS2 9NS, UK, and Center for Reproductive Medicine of the Vrije Universiteit Brussel, Brussels, Belgium. adam.balen@leedsth.nhs.uk
Platteau
Peter
P
Andersen
Anders Nyboe
AN
Devroey
Paul
P
Helmgaard
Lisbeth
L
Arce
Joan-Carles
JC
D002996:Clomiphene / Q000627:therapeutic use; D005260:Female; D005640:Follicle Stimulating Hormone / Q000627:therapeutic use*; D037201:Follicle Stimulating Hormone, beta Subunit / Q000737:chemistry; D006801:Humans; D007247:Infertility, Female / Q000628:therapy*; D010060:Ovulation / Q000187:drug effects; D010062:Ovulation Induction / Q000379:methods*; D011085:Polycystic Ovary Syndrome / Q000188:drug therapy*; D011247:Pregnancy; D020033:Protein Isoforms; D011994:Recombinant Proteins / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome
D037201:Follicle Stimulating Hormone, beta Subunit; D020033:Protein Isoforms; D011994:Recombinant Proteins; D002996:Clomiphene; D005640:Follicle Stimulating Hormone