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Volume 91, Issue 4, Pages 1005-1011 (April 2009)


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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

Valerie L. Baker, M.D.abCorresponding Author Informationemail address, Victor Y. Fujimoto, M.D.c, L. Michael Kettel, M.D.d, G. David Adamson, M.D.b, Fred Hoehler, Ph.D.e, Clarence E. Jones, Ph.D.f, Michael R. Soules, M.D.g

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.

a Obstetrics and Gynecology, Stanford University Medical Center, Stanford, California

b Fertility Physicians of Northern California, San Jose, California

c Obstetrics, Gynecology, and Reproductive Sciences, University of California, San Francisco, California

d San Diego Fertility Center, San Diego, California

e Biostatistician Consultant, Orange, California

f Consultant, Huntington Beach, California

g Seattle Reproductive Medicine, Seattle, Washington

Corresponding Author InformationReprint 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.

PII: S0015-0282(08)00159-3

doi:10.1016/j.fertnstert.2008.01.064


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