The Experts below are selected from a list of 78 Experts worldwide ranked by ideXlab platform
Dennis C Marshall - One of the best experts on this subject based on the ideXlab platform.
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Highly purified human-derived follicle-stimulating hormone (Bravelle®) has equivalent efficacy to Follitropin-beta (Follistim ®) in infertile women undergoing in vitro fertilization
Reproductive biology and endocrinology : RB&E, 2003Co-Authors: Richard P. Dickey, John E Nichols, Michael P. Steinkampf, Benjamin Gocial, Melvin Thornton, Bobby W Webster, Sandra M Bello, Jack Crain, Dennis C MarshallAbstract: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.
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highly purified human derived follicle stimulating hormone bravelle has equivalent efficacy to Follitropin beta follistim in infertile women undergoing in vitro fertilization
Reproductive Biology and Endocrinology, 2003Co-Authors: Richard P. Dickey, John E Nichols, Michael P. Steinkampf, Benjamin Gocial, Melvin Thornton, Jack Crain, Bobby Webster, S Bello, Dennis C MarshallAbstract: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, parallelgroup, 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 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(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.
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Highly purified human-derived follicle-stimulating hormone (Bravelle®) has equivalent efficacy to Follitropin-beta (Follistim ®) in infertile women undergoing in vitro fertilization
Reproductive Biology and Endocrinology, 2003Co-Authors: Richard P. Dickey, John E Nichols, Michael P. Steinkampf, Benjamin Gocial, Melvin Thornton, Bobby W Webster, Sandra M Bello, Jack Crain, Dennis C MarshallAbstract: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 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(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.
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comparison of the efficacy and safety of a highly purified human follicle stimulating hormone bravelle and Recombinant Follitropin β for in vitro fertilization a prospective randomized study
Fertility and Sterility, 2002Co-Authors: Richard P. Dickey, John E Nichols, Melvin Thornton, Dennis C Marshall, S H Fein, R V NardiAbstract:Abstract 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 E 2 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 E 2 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.
Richard P. Dickey - One of the best experts on this subject based on the ideXlab platform.
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Highly purified human-derived follicle-stimulating hormone (Bravelle®) has equivalent efficacy to Follitropin-beta (Follistim ®) in infertile women undergoing in vitro fertilization
Reproductive biology and endocrinology : RB&E, 2003Co-Authors: Richard P. Dickey, John E Nichols, Michael P. Steinkampf, Benjamin Gocial, Melvin Thornton, Bobby W Webster, Sandra M Bello, Jack Crain, Dennis C MarshallAbstract: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.
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highly purified human derived follicle stimulating hormone bravelle has equivalent efficacy to Follitropin beta follistim in infertile women undergoing in vitro fertilization
Reproductive Biology and Endocrinology, 2003Co-Authors: Richard P. Dickey, John E Nichols, Michael P. Steinkampf, Benjamin Gocial, Melvin Thornton, Jack Crain, Bobby Webster, S Bello, Dennis C MarshallAbstract: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, parallelgroup, 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 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(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.
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Highly purified human-derived follicle-stimulating hormone (Bravelle®) has equivalent efficacy to Follitropin-beta (Follistim ®) in infertile women undergoing in vitro fertilization
Reproductive Biology and Endocrinology, 2003Co-Authors: Richard P. Dickey, John E Nichols, Michael P. Steinkampf, Benjamin Gocial, Melvin Thornton, Bobby W Webster, Sandra M Bello, Jack Crain, Dennis C MarshallAbstract: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 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(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.
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comparison of the efficacy and safety of a highly purified human follicle stimulating hormone bravelle and Recombinant Follitropin β for in vitro fertilization a prospective randomized study
Fertility and Sterility, 2002Co-Authors: Richard P. Dickey, John E Nichols, Melvin Thornton, Dennis C Marshall, S H Fein, R V NardiAbstract:Abstract 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 E 2 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 E 2 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.
John E Nichols - One of the best experts on this subject based on the ideXlab platform.
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Highly purified human-derived follicle-stimulating hormone (Bravelle®) has equivalent efficacy to Follitropin-beta (Follistim ®) in infertile women undergoing in vitro fertilization
Reproductive biology and endocrinology : RB&E, 2003Co-Authors: Richard P. Dickey, John E Nichols, Michael P. Steinkampf, Benjamin Gocial, Melvin Thornton, Bobby W Webster, Sandra M Bello, Jack Crain, Dennis C MarshallAbstract: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.
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highly purified human derived follicle stimulating hormone bravelle has equivalent efficacy to Follitropin beta follistim in infertile women undergoing in vitro fertilization
Reproductive Biology and Endocrinology, 2003Co-Authors: Richard P. Dickey, John E Nichols, Michael P. Steinkampf, Benjamin Gocial, Melvin Thornton, Jack Crain, Bobby Webster, S Bello, Dennis C MarshallAbstract: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, parallelgroup, 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 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(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.
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Highly purified human-derived follicle-stimulating hormone (Bravelle®) has equivalent efficacy to Follitropin-beta (Follistim ®) in infertile women undergoing in vitro fertilization
Reproductive Biology and Endocrinology, 2003Co-Authors: Richard P. Dickey, John E Nichols, Michael P. Steinkampf, Benjamin Gocial, Melvin Thornton, Bobby W Webster, Sandra M Bello, Jack Crain, Dennis C MarshallAbstract: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 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(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.
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comparison of the efficacy and safety of a highly purified human follicle stimulating hormone bravelle and Recombinant Follitropin β for in vitro fertilization a prospective randomized study
Fertility and Sterility, 2002Co-Authors: Richard P. Dickey, John E Nichols, Melvin Thornton, Dennis C Marshall, S H Fein, R V NardiAbstract:Abstract 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 E 2 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 E 2 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.
Melvin Thornton - One of the best experts on this subject based on the ideXlab platform.
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Highly purified human-derived follicle-stimulating hormone (Bravelle®) has equivalent efficacy to Follitropin-beta (Follistim ®) in infertile women undergoing in vitro fertilization
Reproductive biology and endocrinology : RB&E, 2003Co-Authors: Richard P. Dickey, John E Nichols, Michael P. Steinkampf, Benjamin Gocial, Melvin Thornton, Bobby W Webster, Sandra M Bello, Jack Crain, Dennis C MarshallAbstract: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.
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highly purified human derived follicle stimulating hormone bravelle has equivalent efficacy to Follitropin beta follistim in infertile women undergoing in vitro fertilization
Reproductive Biology and Endocrinology, 2003Co-Authors: Richard P. Dickey, John E Nichols, Michael P. Steinkampf, Benjamin Gocial, Melvin Thornton, Jack Crain, Bobby Webster, S Bello, Dennis C MarshallAbstract: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, parallelgroup, 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 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(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.
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Highly purified human-derived follicle-stimulating hormone (Bravelle®) has equivalent efficacy to Follitropin-beta (Follistim ®) in infertile women undergoing in vitro fertilization
Reproductive Biology and Endocrinology, 2003Co-Authors: Richard P. Dickey, John E Nichols, Michael P. Steinkampf, Benjamin Gocial, Melvin Thornton, Bobby W Webster, Sandra M Bello, Jack Crain, Dennis C MarshallAbstract: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 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(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.
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comparison of the efficacy and safety of a highly purified human follicle stimulating hormone bravelle and Recombinant Follitropin β for in vitro fertilization a prospective randomized study
Fertility and Sterility, 2002Co-Authors: Richard P. Dickey, John E Nichols, Melvin Thornton, Dennis C Marshall, S H Fein, R V NardiAbstract:Abstract 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 E 2 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 E 2 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.
Michael P. Steinkampf - One of the best experts on this subject based on the ideXlab platform.
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Highly purified human-derived follicle-stimulating hormone (Bravelle®) has equivalent efficacy to Follitropin-beta (Follistim ®) in infertile women undergoing in vitro fertilization
Reproductive biology and endocrinology : RB&E, 2003Co-Authors: Richard P. Dickey, John E Nichols, Michael P. Steinkampf, Benjamin Gocial, Melvin Thornton, Bobby W Webster, Sandra M Bello, Jack Crain, Dennis C MarshallAbstract: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.
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highly purified human derived follicle stimulating hormone bravelle has equivalent efficacy to Follitropin beta follistim in infertile women undergoing in vitro fertilization
Reproductive Biology and Endocrinology, 2003Co-Authors: Richard P. Dickey, John E Nichols, Michael P. Steinkampf, Benjamin Gocial, Melvin Thornton, Jack Crain, Bobby Webster, S Bello, Dennis C MarshallAbstract: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, parallelgroup, 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 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(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.
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Highly purified human-derived follicle-stimulating hormone (Bravelle®) has equivalent efficacy to Follitropin-beta (Follistim ®) in infertile women undergoing in vitro fertilization
Reproductive Biology and Endocrinology, 2003Co-Authors: Richard P. Dickey, John E Nichols, Michael P. Steinkampf, Benjamin Gocial, Melvin Thornton, Bobby W Webster, Sandra M Bello, Jack Crain, Dennis C MarshallAbstract: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 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(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.