Wednesday, December 16, 2015

(OvaScience) JAPAN AUGMENT preceptorship program自體粒線體移植 強化卵子 治療不孕症

讓卵年輕化治不孕 日首度批准臨床研究 時間:2015-12-13 20:11 新聞引據:中央社 日本產科婦人科學會12日宣布,批准大阪1家治療不孕症診所實施讓患者卵子「年輕化」的新型臨床治療。雖然海外已有這種案例,但在日本還是首度批准進行臨床研究。這家申請進行臨床研究的大阪市診所,將以腹腔鏡手術取出不孕症患者卵巢組織的一部分,然後抽出粒線體(mitochondria)這種製造細胞所需能源的細胞器,讓卵子「年輕化」之後,再注入患者本人的卵子,並注入精子一同進行體外受精,以增加受孕機率。日本產科婦人科學會的倫理委員會12日召開理事會,批准這項臨床研究。醫學報告顯示,這種治療不孕症的臨床研究在加拿大、土耳其等海外國家已有200例,成功生產的超過20。日本產科婦人科學會的倫理委員會表示,這種不孕症的治療效果還未充分受到檢視,屬於初期的研究及實驗階段,不能否認,還存在著未解的問題。該倫理委員會還表示,因為是自體移植,沒有道德倫理上的疑慮,牴觸法律或國家政策方針的可能性也低。但其他的醫療機關如果也想進行臨床研究,仍需個別向學會申請批准。

IVF JAPAN Begins Preceptorship Program with AUGMENT Treatment -December 14, 2015 07:30 AM Eastern Standard Time  WALTHAM, Mass.--(BUSINESS WIRE)--OvaScienceSM (NASDAQ:OVAS), a global fertility company focused on the discovery, development and commercialization of new treatment options, today announced the AUGMENTSM fertility treatment is being offered in Japan through a preceptorship program at IVF JAPAN, one of the most prestigious fertility clinic systems in Japan. The initiation of the preceptorship program, in which patients will receive the AUGMENT treatment, follows approval from the Japan Society of Obstetrics and Gynecology (JSOG)."The introduction of the AUGMENT treatment in Japan represents an important milestone for patients," said Michelle Dipp, M.D., Ph.D., Chief Executive Officer of OvaScience. "We look forward to working to expand the availability of the AUGMENT treatment to women who experience poor egg health and are in need of new fertility treatment options." Under the leadership of Professor Yoshiharu Morimoto, M.D., Ph.D., IVF JAPAN conducts a combined 10,000 in vitro fertilization (IVF) cycles annually at its three clinics. Professor Morimoto is the President of the Pacific Society of Reproductive Medicine, the Past President of the Asia Pacific Initiative on Reproduction, the President of the Japan Society of Assisted Reproduction and the President of the Japan Society of Reproductive Psychology. Japan is the world's largest IVF market, accounting for more than 326,000 IVF cycles annually.1 IVF JAPAN is the first clinic network to offer the AUGMENT treatment in the region. The treatment is being offered through a preceptorship program, designed for the clinic to obtain patient experience and training before offering the treatment more broadly."Bringing forward innovative technologies on behalf of our patients is part of our mission at IVF JAPAN," said Professor Morimoto, Chief Executive Officer of IVF JAPAN. "We are encouraged by the patient experiences with the AUGMENT treatment published to date, and look forward to seeing how it may improve the chance of success for women who are experiencing poor egg and embryo quality in our clinic." The AUGMENT treatment is not available in the United States.

First Baby Born with OvaScience's AUGMENT Fertility Treatment- Innovative Fertility Treatment Developed to Improve Egg Health, a Major Factor in IVF Success -CAMBRIDGE, Mass.—(BUSINESS WIRE)—May 7, 2015—OvaScienceSM (NASDAQ: OVAS), a global fertility company focused on the discovery, development and commercialization of new treatment options, announced today that one of the first patients who received the AUGMENTSM treatment gave birth to a healthy baby boy in Toronto, Ontario, Canada. "Before my husband and I learned about the AUGMENT treatment, we struggled with infertility due to my egg quality and felt somewhat discouraged," said the mother. "Now we are optimistic that our experience will show couples, especially those who suffer from poor egg health, that they have a new option to have their own biological child." Egg health is a key factor in female fertility. While many factors contribute to egg health, having adequate levels of energy-producing mitochondria inside of the egg is essential for healthy fertilization and embryo development. The AUGMENT treatment is designed to improve the health of a woman's existing eggs, and enhance the IVF procedure. The AUGMENT treatment uses the energy-producing mitochondria from a woman's own egg precursor (EggPCSM) cells – immature egg cells found in the protective lining of her ovaries – to supplement the existing mitochondria in her eggs. The AUGMENT treatment is not available in the United States."You expect to see compromised egg health as women age, but many younger women also have poor egg health for various reasons. I was surprised to discover that the mother's eggs and embryo quality were so poor, despite her 34 years of age," said Marjorie E. Dixon, M.D.C.M., F.R.C.S.(C), Medical Director at First Steps Fertility, Assistant Professor of Reproductive Endocrinology and Infertility at the University of Toronto, and the patient's reproductive endocrinologist. "Based on my assessment of significantly diminished embryo quality in a failed IVF cycle and several other factors contributing to her infertility, she had few options. When I learned about the AUGMENT treatment, I was excited to offer this couple a new opportunity to have their own biological child.""We were the first clinic to offer the AUGMENT treatment in Canada, and I have seen firsthand the positive impact it has on pregnancy rates, particularly in women with poor prognoses," said Robert F. Casper, M.D., F.R.C.S.(C), Senior Investigator, Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital, Toronto, and Medical Director of TCART Fertility Partners, where this AUGMENT treatment procedure took place. "The success of IVF depends on many factors; however, most fertility experts agree that egg and embryo quality are key prognostic indicators. The AUGMENT treatment was developed to address egg and embryo quality, and we are pleased to continue providing the AUGMENT treatment to women who are seeking new options." One in six couples worldwide has trouble getting pregnant naturally. IVF is the standard infertility treatment; however, it often fails. Many physicians believe that poor egg health accounts for the majority of female-related infertility."Our mission at OvaScience is to bring new fertility treatment options to women with the goal of helping them build their families," said Michelle Dipp, M.D., Ph.D., Chief Executive Officer of OvaScience. "We look forward to bringing the AUGMENT treatment to more women around the world as well as future treatment options from our egg precursor cell technology."

About the AUGMENTSM Treatment The AUGMENT treatment is the first fertility treatment available to patients based on OvaScience's proprietary egg precursor (EggPCSM) cell technology. The AUGMENT treatment is designed to improve the health of a woman's existing eggs, and enhance the IVF procedure. The AUGMENT treatment uses energy-producing mitochondria from a woman's own EggPC cells, which are immature egg cells found in the protective lining of the ovaries, to supplement the existing mitochondria in her eggs. This treatment is designed to improve egg health by increasing the eggs' energy levels for embryo development. Egg health is a key factor in IVF success. The AUGMENT treatment is available in select international IVF clinics, and initial positive clinical experiences of pregnancies with the treatment have been reported. The AUGMENT treatment is not available in the United States. For more information, please visit www.augmenttreatment.com.

About OvaScience  OvaScience (NASDAQ: OVAS) is a global fertility company dedicated to improving treatment options for women around the world. OvaScience is discovering, developing and commercializing new fertility treatments because we believe women deserve more options. Each OvaScience treatment is based on the Company's proprietary technology platform that leverages the breakthrough discovery of egg precursor (EggPCSM) cells – immature egg cells found inside the protective ovarian lining. The AUGMENTSM treatment, a fertility option specifically designed to improve egg health, is available in certain IVF clinics in select international regions outside of the United States. OvaScience is developing the OvaPrimeSM treatment, which could increase a woman's egg reserve, and the OvaTureSM treatment, a potential next-generation IVF treatment that could help a woman produce healthy, young, fertilizable eggs without hormone injections. For more information, please visit www.ovascience.com and connect with us on Twitter and Facebook. Source: OvaScience

OvaScience Investors Theresa McNeely, 617-299-7356  EVP, Chief Communications Officer tmcneely@ovascience.com  or Media  Cara Mayfield, 617-714-9638  Director, Corporate Communications cmayfield@ovascience.com

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