Highly purified human-derived follicle-stimulating hormone (Bravelle) has equivalent efficacy to follitropin-beta (Follistim) in infertile women undergoing in vitro fertilization.
Reprod Biol Endocrinol
; 1: 63, 2003 Oct 03.
Article
in En
| MEDLINE
| ID: mdl-14609434
ABSTRACT
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.
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Ovulation Induction
/
Fertilization in Vitro
/
Follicle Stimulating Hormone, Human
/
Follicle Stimulating Hormone
/
Infertility, Female
Type of study:
Clinical_trials
Limits:
Adolescent
/
Adult
/
Female
/
Humans
/
Pregnancy
Language:
En
Journal:
Reprod Biol Endocrinol
Journal subject:
ENDOCRINOLOGIA
/
MEDICINA REPRODUTIVA
Year:
2003
Document type:
Article
Affiliation country:
United States