Highly purified human-derived follicle-stimulating hormone (Bravelle) has equivalent efficacy to follitropin-beta (Follistim) in infertile women undergoing in vitro fertilization.
BACKGROUND
These data compare the efficacy and safety of highly purified human-derived follicle-stimulating hormone (Bravelle) and recombinant follitropin-beta (Follistim) in women undergoing in vitro fertilization.


METHODS
This report describes the pooled data from two, nearly identical, randomized, controlled, parallel-group, multicenter studies conducted in a total of 19 academic and private IVF-ET centers in the United States. Infertile premenopausal women underwent pituitary down-regulation using leuprolide acetate followed by a maximum of 12 days of subcutaneous Bravelle (n = 120) or Follistim (n = 118), followed by administration of human chorionic gonadotropin, oocyte retrieval and embryo transfer. The primary efficacy measure was the mean number of oocytes retrieved; secondary efficacy measures included the total dose and duration of gonadotropin treatment; peak serum estradion levels; embryo transfer and implantation rates; chemical, clinical and continuing pregnancies; and live birth rates. All adverse events were recorded and injection site pain was recorded daily using a patient, self-assessment diary.


RESULTS
Similar efficacy responses were observed for all outcome parameters in the two treatment groups. Although patients receiving Bravelle consistently reported a greater number of chemical, clinical and continuing pregnancies, as well as an increased rate of live birth, the data did not attain statistical significance (P > 0.05). The overall incidence of adverse events was similar in both groups, but compared to Follistim, injections of Bravelle were reported by patients to be significantly less painful (P < 0.001).


CONCLUSIONS
Bravelle and Follistim had comparable efficacy in controlled ovarian hyperstimulation in women undergoing IVF-ET. There were no differences in the nature or number of adverse events between the treatment groups although Bravelle injections were reported to be significantly less painful.
Dickey
Richard P
RP
Fertility Institute of New Orleans, New Orleans, LA, USA. renee@fertilityinstitute.com
Nichols
John E
JE
Steinkampf
Michael P
MP
Gocial
Benjamin
B
Thornton
Melvin
M
Webster
Bobby W
BW
Bello
Sandra M
SM
Crain
Jack
J
Marshall
Dennis C
DC
D000293:Adolescent; D000328:Adult; D006063:Chorionic Gonadotropin / Q000494:pharmacology; D004624:Embryo Transfer; D005260:Female; D005307:Fertilization in Vitro; D005640:Follicle Stimulating Hormone / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D043373:Follicle Stimulating Hormone, Human / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*; D006801:Humans; D007247:Infertility, Female / Q000628:therapy*; D016729:Leuprolide / Q000494:pharmacology; D009865:Oocytes / Q000166:cytology / Q000502:physiology / Q000637:transplantation; D010062:Ovulation Induction / Q000379:methods*; D010146:Pain / Q000150:complications; D011247:Pregnancy; D011256:Pregnancy Outcome; D016896:Treatment Outcome
D006063:Chorionic Gonadotropin; D043373:Follicle Stimulating Hormone, Human; D005640:Follicle Stimulating Hormone; D016729:Leuprolide