Ovarian Hyperstimulation Syndrome

NEW YORK, April 2, 2024 /PRNewswire/ -- Gameto, a female-led biotechnology company with a mission to redefine women's healthcare, today announced encouraging new findings from a study evaluating how minimal controlled ovarian stimulation (COS) in combination with Fertilo, their novel investigational in vitro maturation (IVM) solution containing engineered ovarian support cells (OSC-IVM) to mature eggs outside of the body, affected patients' egg retrieval experiences when compared to conventional stimulation. The data analysis found that women undergoing minimal hormonal stimulation for OSC-IVM reported experiencing few side effects, lower levels of pain after retrieval, and higher satisfaction levels with the shortened stimulation procedure, compared to conventional stimulation for in vitro fertilization (IVF). "This study is significant because female patients' pain, morbidity, and inconvenience are frequently minimized and neglected in the healthcare setting, and often more so for women pursuing fertility treatments and egg or embryo freezing," said Dr. Dina Radenkovic, Chief Executive Officer and co-founder of Gameto. "We are encouraged by these and previously published efficacy data which demonstrate that combining minimal hormonal stimulation with our investigational in vitro maturation solution may help women navigating fertility treatments avoid many of the common side effects associated with the conventional IVF hormone protocol. We care about the efficacy but also about the experience." Fertilo, Gameto's lead investigational program, is a solution derived from induced pluripotent stem cells (iPSC) and designed to mature eggs outside of the body as part of minimal hormonal stimulation cycles for in vitro fertilization and egg freezing. Fertilo is cleared for commercialization in Australia and in large markets in Latin America. Gameto's goal in developing Fertilo is to make fertility treatments more convenient, safer, and accessible for a wider patient population. In the retrospective survey study, the minimal stimulation OSC-IVM cycles were associated with significant reductions in reported side effects and levels of pain. The data analysis found that severe pain was reported by 38.46% of patients undergoing conventional COS compared to only 7.69% of participants in the minimal stimulation OSC-IVM cohort. The majority of women in the minimal stimulation OSC-IVM cohort did not experience common IVF side effects: 86% reported no breast swelling, 76% reported having no pelvic or abdominal pain, 96% reported having no nausea or vomiting, and 96% reported having no bleeding. Approximately one-third of patients undergoing conventional COS experience ovarian hyperstimulation syndrome (OHSS), a painful and potentially dangerous response to the conventional stimulation protocol, with one to five percent of cases requiring hospitalization.[1],[2] In contrast, the participants in this analysis who underwent minimal ovarian stimulation cycles followed by OSC-IVM yielded no incidence of OHSS. Furthermore, in patients who went through both cycles, 92% of patients expressed they would repeat the minimal stimulation followed by OSC-IVM cycle, relative to 77% in conventional stimulation with IVF. The retrospective survey analysis included a comparison between 110 patients who underwent minimal stimulation cycles followed by OSC-IVM, versus 48 patients who underwent conventional stimulation cycles, and a pairwise comparison with data from 13 patients who themselves underwent both cycles. The manuscript describing these data is available on a preprint server at https://www.medrxiv.org/content/10.1101/2024.03.28.24304995v1 and is concurrently undergoing scientific peer-review for potential publication. Gameto is currently engaged in rigorous preparations to meet the FDA's conditions for Phase 3 trial initiation. For more information about Gameto and how the company is redefining women's healthcare, visit gametogen.com. About Gameto Gameto is a biotechnology company developing novel treatment solutions for women's health, starting with infertility. Gameto brings together an experienced scientific management team with the vision and passion to develop a product suite to support women throughout their reproductive journeys. Gameto's lead program, Fertilo, aims to make IVF and egg freezing shorter, safer, and more accessible through reduced hormonal injections by maturing eggs outside of the body. Gameto is led by physician-turned-entrepreneur Dina Radenkovic as CEO and serial entrepreneur and founder of North America's largest fertility network Prelude Fertility, Martin Varsavsky, as Chairman. For more information, go to gametogen.com or follow us on Twitter and Instagram @gametogen and on LinkedIn.

NEW YORK, Sept. 14, 2022 /PRNewswire/ -- Gameto, a biotechnology company using cell engineering to develop therapeutics for diseases of the female reproductive system, today announced that it has raised an additional $17 million in funding from global software investor Insight Partners, Future Ventures, Arcadia Investment Partners, Bold Capital Partners, Plum Alley, Myelin VC, TA Ventures, Gaingels, Korify Capital, and other existing investors. The new financing brings the total capital raised since inception to $40M. Gameto's underlying cell engineering platform was developed in stealth under a scientific research agreement with George Church's lab at Harvard Medical School. In January, Gameto announced plans for three sequenced programs. The first program, Fertilo, is a biologic for IVF and egg freezing, aiming to make the process shorter, safer, and more effective. The following programs include Deovo, an organoid of the female reproductive system, and Ameno, a cell-based therapeutic to ameliorate the health consequences of primary ovarian insufficiency and menopause. Fertilo is a biologic for egg maturation derived from engineered ovarian supporting cells to facilitate a lower hormonal burden during IVF and egg freezing. This will allow women to obtain eggs in a shorter, more natural process without the risk of ovarian hyperstimulation syndrome. Currently, egg maturation drugs are hormone-based and the process is long, and expensive, with potential side effects. Gameto aims to bring to market a new mechanism of action to both reduce the number of hormonal injections and improve the efficacy of the process. Fertilo has entered preclinical development in partnership with leading clinics in the US and in Spain, the largest ART [Assisted Reproductive Technology] market in Europe. Partner clinics include Extend Fertility, RMA, Pozitivf, Ovation Fertility, Clinica Tambre, and Hospital Ruber Internacional. Inception Fertility™ (Inception), the largest provider of comprehensive fertility services in North America, also recently launched a study with Gameto to identify new techniques to improve in-vitro maturation. Through its ancillary brands, Inception serves as a mechanism to draw participants from its ecosystem of companies to take part in this and other groundbreaking studies that will elevate sciences and advancements in ART. Inception's network of fertility clinics, The Prelude Network® (Prelude), is the largest network to partner with Gameto, as it has over 85 locations across North America. Prelude was also founded by Gameto co-founder and chairman Martin Varsavsky. "Gameto is developing novel treatments across fertility and women's health, leveraging its proprietary technology to create a robust pipeline of compelling products," said Dylan Morris, Managing Director at Insight Partners. "We are excited to partner with the Gameto team as they translate their transformational developments into therapies that will ultimately improve human lives." "We're thrilled to have Insight join us in our mission to create novel therapies that improve women's lives," said Dr. Dina Radenkovic, CEO of Gameto. "Infertility is one of the first manifestations of accelerated ovarian decline. I'm incredibly excited that Gameto's technology could enable much cheaper, safer, faster, and more effective egg freezing and IVF. Our program Fertilo could help give women the power to have families at our own pace, when and how we want to do so." In order to support preclinical testing, Gameto has significantly expanded its global footprint with a headquarters and laboratory in New York and a European office in Madrid. Simultaneously, Gameto has formed a Bioethics committee composed of Professor Alta Charo, the Warren P. Knowles Professor of Law and Bioethics at the University of Wisconsin–Madison and a leading American authority on bioethics; Leslie Schrock, author, entrepreneur, and angel investor working at the convergence of health and technology, primarily in women's and family health; and Andrew McLaughlin, former Deputy Chief Technology Officer of the United States, to ensure that Gameto's developments are used for positive change. About Gameto: Based in New York and Madrid, Gameto is a biotechnology company using cell engineering to develop therapeutics for diseases of the female reproductive system. Gameto brings together an experienced scientific management team with vision and passion to develop groundbreaking products for women's health. Gameto is led by physician-turned-entrepreneur Dina Radenkovic as CEO and serial entrepreneur and leader in the fertility space Martin Varsavsky as Chairman. For more information, go to gametogen.com or follow us on Twitter @gametogen. About Insight Partners: Insight Partners is a global software investor partnering with high-growth technology, software, and Internet startup and ScaleUp companies that are driving transformative change in their industries. As of June 30, 2022, the firm has over $80B in regulatory assets under management. Insight Partners has invested in more than 700 companies worldwide and has seen over 55 portfolio companies achieve an IPO. Headquartered in New York City, Insight has offices in London, Tel Aviv, and Palo Alto. Insight's mission is to find, fund, and work successfully with visionary executives, providing them with practical, hands-on software expertise to foster long-term success. Insight Partners meets great software leaders where they are in their growth journey, from their first investment to IPO. For more information on Insight and all its investments, visit insightpartners.com or follow us on Twitter @insightpartners.

FRIDAY, July 14, 2023 -- Testing positive for a COVID-19 infection during a particular phase of fertility treatment could reduce the odds for a successful pregnancy, a new study says. That phase of treatment is called controlled ovarian stimulation — a technique used to induce ovulation during in vitro fertilization (IVF). Researchers led by Fen Tian , of Central South University in China, say doctors should counsel couples undergoing controlled ovarian stimulation that COVID-19 infection may affect the quality of embryos and the stage of development prior to that, when the ball of cells is a “blastocyst.” But some fertility experts expressed reservations about the study, which followed 585 couples in China. PCR testing was used to determine if either partner or both had a COVID-19 infection at the time of ovarian stimulation. Researchers said 135 tested positive. Although the study was the largest to date, it was still relatively small, said Dr. Lilli Zimmerman , who specializes in reproductive endocrinology, infertility and obstetrics/gynecology for Northwell Health in Manhasset, N.Y. Zimmerman was not involved in the study. “My main takeaway was that many more studies are needed about this topic. COVID is still a very new kind of infection, even this many years into the pandemic. And I think that it's going to take many studies, for many years, to really elicit the effects of COVID infection on reproductive outcomes, particularly in regards to IVF,” Zimmerman said. Policies about COVID-19 testing and procedures can vary from one health care system to another and have shifted throughout the pandemic, she noted. There can be downsides for the patient in delaying IVF, Zimmerman said, including that aging continues to happen, which can affect fertility. Stopping before a planned egg retrieval far into the cycle can also lead to ovarian hyperstimulation and pain, she said. The research for this study was retrospective, using data from seven reproductive centers in four provinces across China, from October through December 2022. The researchers found that couples with a COVID-19 infection had significantly lower top-quality embryos and blastocyst, blastocyst formation and available blastocyst rates than couples without an infection during controlled ovarian stimulation. Based on the study, it would make sense to avoid starting an IVF cycle in someone who has a known infection and to be extra diligent during a stimulation to avoid getting exposed to an infection, said Dr. Lindsay Kroener , a reproductive endocrinology and infertility specialist at University of California, Los Angeles Health. “It is important to note that this study does not look at clinical outcomes such as pregnancy rates or live birth rates from embryos transferred from these cycles,” said Kroener, who wasn't involved in the study. “While this data does demonstrate a negative impact on blastocysts development and quality when one or both partners are infected with SARS-CoV-2, the absolute difference in outcomes is still fairly small,” Kroener added. It also doesn’t seem to affect the number of oocytes (immature eggs) retrieved, Kroener noted. “Based on this study, active infection negatively impacts embryology outcomes, but even cycles from SARS-CoV-2-infected patients still yielded usable, high-quality embryos,” Kroener said. A positive COVID-19 test doesn't necessarily mean the IVF cycle must be cancelled, she added. "The decision to move forward with a stimulation and retrieval versus cancelling a cycle may depend on a number of factors, including patient counseling, how far along the patient is in their stimulation, and the amount of time and medication that has been invested, as well as whether the center will allow them to proceed with retrieval with active infection,” Kroener said. An infertility center also might delay or cancel procedures in patients who have an active COVID-19 infection because some procedures use anesthesia, which might create complications for someone with respiratory symptoms from the infection. There is also concern that staff and other patients might be exposed to the virus, Kroener said. An embryo transfer wouldn’t be done in a patient with an active COVID-19 infection because of the risks associated with COVID infection during pregnancy, she noted. Controlled ovarian stimulation during IVF involves taking daily injections of hormonal medications known as gonadotropins for eight to 12 days. Patients are monitored regularly with transvaginal ultrasounds and blood work to determine when the follicles are the optimal size to trigger ovulation, Kroener explained. Egg removal is typically done about 35 to 36 hours after a trigger shot is given, with the eggs removed from the follicles in the ovary through a needle, she said. Other studies have shown no evidence of the virus in follicular fluid, Zimmerman noted. “We have no way to know long-term outcomes and this is what we've been counseling patients since the beginning of the pandemic. We have no way to know if there's any long-term outcomes on babies, and that's ultimately the reproductive goal of IVF,” Zimmerman said. The study results were published online July 13 in JAMA Network Open . Sources Lindsay Kroener, MD, reproductive endocrinology and infertility specialist, UCLA Health, Los Angeles Lilli Zimmerman, MD, reproductive endocrinology/infertility and obstetrics/gynecology, Northwell Health, Manhasset, N.Y. JAMA Network Open , July 13, 2023, online Posted July 2023 Further Support and Information on COVID-19 COVID-19: Prevention & Investigational Treatments COVID-19 Support Group Coronavirus Disease Guide