Highly purified human-derived follicle-stimulating hormone (Bravelle® has equivalent efficacy to follitropin-beta (Follistim ®) in infertile women undergoing in vitro fertilization

被引:14
作者
Richard P Dickey
John E Nichols
Michael P Steinkampf
Benjamin Gocial
Melvin Thornton
Bobby W Webster
Sandra M Bello
Jack Crain
Dennis C Marshall
机构
[1] Fertility Institute of New Orleans, New Orleans, LA
[2] Greenville Memorial Hospital, Greenville, SC
[3] University of Alabama at Birmingham, Birmingham, LA
[4] Pennsylvinia Reproductive Associates, Plymouth Meeting, PA
[5] Center for Repro. Health/Gynecology, Valencia, CA
[6] Womans' Center for Fertility, Baton Rouge, LA
[7] West Texas Reproductive Center, Odessa, TX
[8] Reprodictive Endocrine Associate, Charlotte, NC
[9] Ferring Pharmaceutical Inc., Suffer, NY 10901
[10] Women's and Infants Hospital, Providence, RI
[11] Oregon Health Science University, Women's Health Research Unit, Portland, OR
[12] Advanced Institute of Fertility, Milwaukee, WI
[13] San Diego Fertility Center, San Diego, CA
[14] Reproductive Biology Associates, Atlanta, GA
[15] University of Tennessee, Memphis, TN
[16] Repro. Medicine and Fertility Center, Colorado Springs, CO
[17] Southeastern Fertility Center, Mount Pleasant, SC
[18] Abington Reproductive Medicine, Abington, PA
关键词
Luteinizing Hormone; Follicle Stimulate Hormone; Oocyte Retrieval; Control Ovarian Hyperstimulation; Injection Site Pain;
D O I
10.1186/1477-7827-1-63
中图分类号
学科分类号
摘要
Background. These data compare the efficacy and safety of highly purified human-derived follicle-stimulating hormone (Bravelle(R)) and recombinant follitropin-β (Follistim(R)) 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(R) (n = 120) or Follistim(R) (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(R) consistently reported a greater number of chemical, clinical and continuing pregnancies, as well as an increased rate oflive 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(R), injections of Bravelle(R) were reported by patients to be significantly less painful (P < 0.001). Conclusions. Bravelle(R) and Follistim(R) 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(R) injections were reported to be significantly less painful. © 2003 Dickey et al; licensee BioMed Central Ltd.
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页数:8
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