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.
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.


METHODS
A randomized, controlled, investigator-blind trial.


METHODS
Four assisted reproductive technology centers.


METHODS
One hundred fifty-two IVF patients.


METHODS
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.


METHODS
Number of oocytes, clinical pregnancy rate, and live birth rate with HP-hFSH versus rFSH.


RESULTS
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%).


CONCLUSIONS
There were no statistically significant differences in mean oocyte number, clinical pregnancy rate, or live birth rate between HP-hFSH versus rFSH.
Baker
Valerie L
VL
Obstetrics and Gynecology, Stanford University Medical Center, Stanford, California, USA. vlbaker@stanford.edu
Fujimoto
Victor Y
VY
Kettel
L Michael
LM
Adamson
G David
GD
Hoehler
Fred
F
Jones
Clarence E
CE
Soules
Michael R
MR
D000293:Adolescent; D000328:Adult; D000465:Algorithms; D005260:Female; D005307:Fertilization in Vitro / Q000379:methods*; D005640:Follicle Stimulating Hormone / Q000627:therapeutic use*; D006805:Human Experimentation; D006801:Humans; D007246:Infertility / Q000628:therapy; D010062:Ovulation Induction / Q000379:methods*; D011247:Pregnancy; D018873:Pregnancy Rate; D011994:Recombinant Proteins / Q000627:therapeutic use*; D016037:Single-Blind Method; D016896:Treatment Outcome; D050477:Urofollitropin / Q000302:isolation & purification / Q000627:therapeutic use*; D055815:Young Adult
D011994:Recombinant Proteins; D050477:Urofollitropin; D005640:Follicle Stimulating Hormone