Clinical efficacy of highly purified urinary FSH versus recombinant FSH in volunteers undergoing controlled ovarian stimulation for in vitro fertilization: a randomized, multicenter, investigator-blind trial
Received 18 October 2007; received in revised form 15 January 2008; accepted 15 January 2008. published online 25 March 2008.
Objective
To compare the efficacy of highly purified human urinary follicle stimulating hormone (HP-hFSH) versus human recombinant follitropin-alpha (rFSH) in volunteers undergoing controlled ovarian stimulation for IVF.
Design
A randomized, controlled, investigator-blind trial.
Setting
Four assisted reproductive technology centers.
Patient(s)
One hundred fifty-two IVF patients.
Intervention(s)
Volunteers, aged 18–39, were randomized to HP-hFSH (n = 76) versus rFSH (n = 76) at a starting dose of 300 IU in down-regulated cycles.
Main Outcome Measure(s)
Number of oocytes, clinical pregnancy rate, and live birth rate with HP-hFSH versus rFSH.
Result(s)
The total IU of gonadotropin used did not differ between the two groups. There was no difference in number of oocytes retrieved with HP-hFSH (mean = 16.3) compared with rFSH (mean = 17.1), confidence interval (CI) of difference = −3.79 to +2.18. Clinical pregnancy rate, as defined by the presence of a gestational sac, was 48.7% (CI = 37.0%–60.4%) with HP-hFSH versus 44.7% (CI = 33.3%–56.6%) with rFSH (CI of difference = −11.9% to +19.8%). Live birth rate was 38.2% (29 of 76) in both groups (CI = 27.2%–50.0%), for a difference between groups of 0.0% (CI of the difference = −15.4% to +15.4%).
Conclusion(s)
There were no statistically significant differences in mean oocyte number, clinical pregnancy rate, or live birth rate between HP-hFSH versus rFSH.
gSeattle Reproductive Medicine, Seattle, Washington
Reprint requests: Valerie L. Baker, M.D., Stanford University Medical Center, Department of Obstetrics and Gynecology, Division of Reproductive Endocrinology and Infertility, 300 Pasteur Drive, Room HH333, Stanford, California 94305-5317 (FAX: 650-736-7036).
Study funded by Institut Biochimique SA (IBSA), Switzerland.
Dr. Baker has received research support from IBSA. Dr. Adamson is CEO and Shareholder of Advanced Reproductive Care, is a physician owner of Fertility Physicians of Northern California, has received research support from IBSA, and has been a speaker for Ferring Pharmaceuticals. His spouse is also a shareholder in Advanced Reproductive Care. Dr Hoehler has served as a consultant to IBSA, Vital Therapies, Inc., Pioneer Surgical, Kyphon, Cooper Surgical, and Fziomed. Dr. Jones is a consultant for VitalTherapies, Inc., and IBSA, and as of 7/1/07, became an employee of IBSA. Drs. Fujimoto, Kettel, and Soules report no conflicts of interest.
ABSTRACT