Press Release
<p>RESULTS OF EMBRACE* TRIALS PRESENTED AT THE PACIFIC COAST REPRODUCTIVE SOCIETY MEETING</p>
<p><strong>First-Ever Systematic Evaluation of Mixed Protocols in IVF</strong> </p>
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<td style="font-size:8pt;" align="left" valign="top"><b>Contact:</b></td>
<td style="font-size:8pt;" align="left" valign="top">Marilyn Seiger<br>
Kovak-Likly Communications<br>
203.762.8833 or mseiger@klcpr.com</td>
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<p>Rancho Mirage, CA – April 28, 2003 – Results of clinical trials evaluating the combined use of two human-derived infertility treatments in in vitro fertilization (IVF) – Bravelle<sup>®</sup>, a follicle stimulating hormone (hFSH), and Repronex<sup>®</sup>, a purified human menopausal gonadotropin (hMG), were presented at the 51st Annual Meeting of the Pacific Coast Reproductive Society in Rancho Mirage, CA, April 23 to 27, 2003. An oral presentation and one poster were presented. </p>
<p>“These studies add to a growing body of clinical evidence supporting the use of mixed protocols of LH and FSH in settings that reflect today’s clinical practice,” said William R. Keye, Jr., M.D., director of the Division of Reproductive Endocrinology and Infertility at William Beaumont Hospital in Royal Oaks, MI. “For example, the use of mixed protocols in IVF has increased dramatically during the past several years. We have undertaken the first-ever systematic evaluation of different mixed protocols, using a single daily dose mixed in the same syringe, in the older and younger patient.” </p>
<p><strong>EMBRACE Trials</strong><br/>
William Keye, M.D., lead investigator, presented results of the EMBRACE II study, which assessed the efficacy and safety of Bravelle and Repronex in continuous and sequential dose ratios, when combined in the same syringe and administered subcutaneously, once daily to patients ages 34 to 40 for controlled ovarian hyperstimulation (COH) in in vitro fertilization (IVF). Patients were randomized into three treatment groups and received gonadotropin stimulation (GS) for 15 days. Group A had a 1:1 FSH:hMG ratio throughout the study. Group B began with FSH only and then changed to a 1:1 ratio after stimulation day five. Group C had a 2:1 ratio that, after stimulation day five, was sequentially adjusted to 3:1, 4:1, or 5:1 as needed to a maximum FSH dose of 450 IU. When ultrasound showed three follicles with diameters of 16 mm and acceptable E2 levels , GS was stopped and hCG given the next day; oocytes were retrieved 34-36 hours later. The primary efficacy parameter was the number of oocytes retrieved. </p>
<p>“Across all treatment groups, there were no statistically significant differences in the total numbers of oocytes retrieved or safety results. The combination of human-derived FSH and hMG in the same syringe produced excellent live birth rates in all groups (Group A = 42.1%, Group B = 30.6%, Group C = 38.9%).” </p>
<p>Richard Marrs, M.D., lead investigator, presented results of the EMBRACE I study, which demonstrated similar results, using the same parameters in patients ages 18-33 years. There were however some differences associated with the 1:1 FSH:hMG treatment group where those patients used significantly less FSH during the study and had significantly higher E2 levels. </p>
<p>“These studies demonstrate the effectiveness of single daily subcutaneous doses of human-derived gonadotropins using varying dose ratios. There were no significant between-group differences in safety and efficacy, although a larger study is needed to conclude that the efficacy from the different ratios is equivalent,” said Richard P. Marrs, M.D., director of the Center for Reproductive Medicine at Santa Monica-UCLA Medical Center and partner of California Fertility Partners. “This study confirms previously published work showing that Bravelle and Repronex can be mixed in the same syringe without impacting the bioactivity of FSH and luteinizing hormone (LH)<SUP>1</SUP>.” </p>
<p><strong>About The Investigators</strong><br/>
William R. Keye, Jr., M.D., director of the Division of Reproductive Endocrinology and Infertility at William Beaumont Hospital in Royal Oaks, MI, has 26 year of experience and is board certified in Reproductive Endocrinology and Obstetrics and Gynecology. Dr. Keye received his medical degree from the University of Minnesota Medical School and completed his residency training in obstetrics and gynecology at both the University of Minnesota and the University of California, San Francisco (UCSF). Dr. Keye completed a reproductive endocrinology research program at the University of Michigan, followed by a fellowship in reproductive endocrinology at UCSF. He previously served as the President of the American Society for Reproductive Medicine. </p>
<p>Richard P. Marrs, M.D., director of the Center for Reproductive Medicine at Santa Monica-UCLA Medical Center and partner of California Fertility Partners, is a board certified Reproductive Endocrinologist. He studied medicine and trained in Obstetrics and Gynecology in Texas before studying Reproductive Endocrinology at the University of Southern California (USC). While at USC, he developed one of the country’s first IVF programs. He is internationally recognized for his contributions to the development of IVF. Dr. Marrs serves on the boards of numerous medical and scientific organizations and is a prominent figure in the national and international infertility communities. </p>
<p>*Evaluation of Mixed Protocols with Bravelle and Repronex to Assess Clinical Efficacy </p>
<p>Bravelle and Repronex are registered trademarks of Ferring Pharmaceuticals Inc. </p>
EUFLEXXA (1% sodium hyaluronate) is used to relieve knee pain due to osteoarthritis. It is used in people who do not get enough relief from simple pain medications such as acetaminophen or from exercise and physical therapy.
Important Safety Information
You should not receive this product if you have had any previous allergic reaction to EUFLEXXA or hyaluronan products. You should not have an injection into the knee if you have a knee joint infection or if you have skin disease or infection around the injection site.
EUFLEXXA is only for injection into the knee performed by a qualified doctor. After you receive this injection you may need to avoid activities such as jogging, tennis, heavy lifting, or standing on your feet for a long time (more than one hour). The safety and effectiveness of repeat treatment cycles of EUFLEXXA have not been established. The safety and effectiveness of EUFLEXXA have not been shown in people under 18 years of age.
Side effects sometimes seen when EUFLEXXA is injected into the knee joint were pain, swelling, skin irritation, and tenderness and these were generally mild and did not last long.
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Euflexxa® is a registered trademark of Ferring Pharmaceuticals Inc.
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