Gameto Announces Patient Experience Data Demonstrating Investigational In Vitro Maturation Solution Well Tolerated with Higher Patient Satisfaction Rates than Conventional Fertility Stimulation

2024-04-02

临床结果临床3期

Retrospective survey data compares patient experiences undergoing minimal controlled ovarian stimulation with in vitro maturation to conventional stimulation protocol

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.

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1 Practice Committee of the American Society for Reproductive Medicine. Prevention and treatment of moderate and severe ovarian hyperstimulation syndrome: a guideline. Fertil Steril. 2016;106(7):1634-1647. doi:10.1016/j.fertnstert.2016.08.048

2 The Management of Ovarian Hyperstimulation Syndrome (Green-top Guideline No. 5). Royal College of Obstetricians & Gynaecologists. https://www.rcog.org.uk/guidance/browse-all-guidance/green-top-guidelines/the-management-of-ovarian-hyperstimulation-syndrome-green-top-guideline-no-5/

SOURCE Gameto