Comparison of the efficacy and safety of a highly purified human follicle-stimulating hormone (Bravelle) and recombinant follitropin-beta for in vitro fertilization: a prospective, randomized study.
OBJECTIVE
To compare the efficacy and safety of Bravelle s.c., Bravelle i.m., and Follistim s.c. in patients undergoing controlled ovarian hyperstimulation for IVF-ET.


METHODS
Open-label, randomized, parallel group, multicenter study.


METHODS
Eleven academic and private fertility clinics with experience in IVF-ET.


METHODS
Infertile premenopausal women with regular ovulatory menstrual cycles undergoing IVF-ET.


METHODS
Down-regulation with leuprolide acetate followed by up to 12 days of Bravelle s.c. (n = 60), Bravelle i.m. (n = 59), or Follistim s.c. (n = 58); hCG administration, oocyte retrieval, and ET.


METHODS
Mean number of oocytes retrieved; patients with ET, chemical, clinical and continuing pregnancies; mean peak serum E2 levels; adverse events and injection site pain scores.


RESULTS
There were no significant differences among treatment groups in mean number of oocytes retrieved, peak serum E2 levels, patients with ET, continuing pregnancies, or live births. There were no significant differences among the treatment groups in the number, nature, or intensity of adverse events. Patients treated with Bravelle s.c. or Bravelle i.m. experienced significantly less injection site pain than patients treated with Follistim s.c.


CONCLUSIONS
Bravelle s.c. and Bravelle i.m. are comparable in efficacy and safety to Follistim s.c. in patients undergoing controlled ovarian hyperstimulation for IVF-ET.
Dickey
Richard P
RP
The Fertility Institute of New Orleans, New Orleans, Louisiana, USA.
Thornton
Melvin
M
Nichols
John
J
Marshall
Dennis C
DC
Fein
Seymour H
SH
Nardi
Ronald V
RV
D000328:Adult; D004624:Embryo Transfer; D005260:Female; D005307:Fertilization in Vitro; D005640:Follicle Stimulating Hormone / Q000009:adverse effects / Q000302:isolation & purification / Q000627:therapeutic use*; D006728:Hormones / Q000627:therapeutic use*; D006801:Humans; D007273:Injections, Intramuscular / Q000009:adverse effects; D007279:Injections, Subcutaneous / Q000009:adverse effects; D016729:Leuprolide / Q000627:therapeutic use; D010062:Ovulation Induction; D010146:Pain / Q000209:etiology; D020033:Protein Isoforms / Q000627:therapeutic use; D011994:Recombinant Proteins / Q000009:adverse effects / Q000627:therapeutic use; D012449:Safety
D006728:Hormones; D020033:Protein Isoforms; D011994:Recombinant Proteins; D005640:Follicle Stimulating Hormone; D016729:Leuprolide