Document Detail


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.
MedLine Citation:
PMID:  12057729     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
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. DESIGN: Open-label, randomized, parallel group, multicenter study. SETTING: Eleven academic and private fertility clinics with experience in IVF-ET. PATIENT(S): Infertile premenopausal women with regular ovulatory menstrual cycles undergoing IVF-ET. INTERVENTION(S): 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. MAIN OUTCOME MEASURE(S): 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. RESULT(S): 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. CONCLUSION(S): 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.
Authors:
Richard P Dickey; Melvin Thornton; John Nichols; Dennis C Marshall; Seymour H Fein; Ronald V Nardi;
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Publication Detail:
Type:  Clinical Trial; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't    
Journal Detail:
Title:  Fertility and sterility     Volume:  77     ISSN:  0015-0282     ISO Abbreviation:  Fertil. Steril.     Publication Date:  2002 Jun 
Date Detail:
Created Date:  2002-06-11     Completed Date:  2002-07-03     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  0372772     Medline TA:  Fertil Steril     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1202-8     Citation Subset:  IM    
Affiliation:
The Fertility Institute of New Orleans, New Orleans, Louisiana, USA.
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MeSH Terms
Descriptor/Qualifier:
Adult
Embryo Transfer
Female
Fertilization in Vitro*
Follicle Stimulating Hormone / adverse effects,  isolation & purification,  therapeutic use*
Hormones / therapeutic use*
Humans
Injections, Intramuscular / adverse effects
Injections, Subcutaneous / adverse effects
Leuprolide / therapeutic use
Ovulation Induction
Pain / etiology
Protein Isoforms / therapeutic use
Recombinant Proteins / adverse effects,  therapeutic use
Safety
Chemical
Reg. No./Substance:
0/Hormones; 0/Protein Isoforms; 0/Recombinant Proteins; 53714-56-0/Leuprolide; 9002-68-0/Follicle Stimulating Hormone

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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