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

Fertil Steril. 2009 Apr;91(4):1005-11. doi: 10.1016/j.fertnstert.2008.01.064. Epub 2008 Mar 25.


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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Algorithms
  • Female
  • Fertilization in Vitro / methods*
  • Follicle Stimulating Hormone / therapeutic use*
  • Human Experimentation
  • Humans
  • Infertility / therapy
  • Ovulation Induction / methods*
  • Pregnancy
  • Pregnancy Rate
  • Recombinant Proteins / therapeutic use*
  • Single-Blind Method
  • Treatment Outcome
  • Urofollitropin / isolation & purification
  • Urofollitropin / therapeutic use*
  • Young Adult


  • Recombinant Proteins
  • Urofollitropin
  • Follicle Stimulating Hormone