Ovarian Hyperstimulation Syndrome

Qualified study participants will receive free in vitro maturation treatment at CCRM Fertility DENVER, April 4, 2023 /PRNewswire/ -- CCRM Fertility, a global pioneer in fertility treatment, research and science, is seeking participants for a new study on in vitro maturation (IVM). IVM requires less hormones to stimulate the ovaries than IVF, making it more affordable than IVF with fewer side effects. Participants that qualify for the study will receive a free cycle of IVM treatment at CCRM Fertility including a new patient consultation, fertility testing, preimplantation genetic testing for aneuploidies (PGT-A), anesthesia and some medication. "IVM works by minimal stimulation of the ovaries with injectable hormones and after a few days, the immature eggs are retrieved from the patient, and are then matured in our state-of-the-art IVF lab," said CCRM Fertility Research Director Ye Yuan, Ph.D. "Based on our published research, CCRM Fertility has developed a new maturation system that helps these eggs mature successfully. Once mature, the process is identical to a typical IVF cycle." No longer considered experimental by the American Society of Reproductive Medicine (ASRM), IVM requires significantly less hormonal stimulation than IVF, which dramatically reduces the number of injections patients must receive. It also reduces the side effects often present with hormone treatment, and virtually eliminates the risk of ovarian hyperstimulation syndrome (OHSS), which causes the ovaries to swell and can cause severe pain. IVM could be especially beneficial to individuals who are at greater risk of OHSS, such as those with polycystic ovary syndrome (PCOS). "While IVM is offered in other countries internationally, CCRM Fertility is paving the way to bring this treatment to the U.S., allowing alternative and less invasive options for individuals, particularly those with PCOS, looking to start, grow or complete their families," said Dr. Yuan. In two previous IVM studies conducted by CCRM Fertility, initial results found that 41% of PCOS patients who had received IVM treatment have had live births or an ongoing pregnancy. The patients in these studies had poorer prognosis (due to age and other complications) than CCRM Fertility's targeted patients for its upcoming clinical trial. CCRM Fertility expects at least comparable or even better outcomes for its current study. For inclusion in the IVM study, all of the following criteria must be fulfilled: Ages 18 – 38 years old Infertile women diagnosed with PCOS or polycystic ovaries, or infertile women with good ovarian reserve Antral follicle count (AFC) greater than 24 AMH greater than 3.5 ng/ml Body Mass Index less than 35 Accept to have embryos biopsied for PGT Intend to perform embryo transfer within 4 months after completing the IVM cycle Paternal (or donor) age <45, ejaculated sperm collection only (partner frozen and donor sperm acceptable), sperm morphology (strict criteria) >1%, motility > 20% and sperm count > 10 million per ml (so samples can be prepared through standard procedure) Patients may not have had more than two failed IVF cycles in the past. To learn more, please reach out to Rachel Makloski at [email protected]. To be considered for the IVM study, please fill out the following form. About CCRM Fertility CCRM Fertility is a global pioneer in fertility treatment, research and science. Founded by Dr. William Schoolcraft over 35 years ago, CCRM Fertility specializes in the most advanced fertility treatments, with deep expertise in IVF, fertility testing, egg freezing, preimplantation genetic testing, third party reproduction and egg donation. CCRM Fertility leverages its own data and a dedicated team of in-house reproductive endocrinologists, embryologists and geneticists to deliver industry-leading outcomes. CCRM serves 13 major metropolitan areas with 36 locations across North American, including Atlanta, Boston, Dallas-Fort Worth, Delaware, Denver, Houston, New Jersey, New York, Northern Virginia/D.C., Minneapolis, Orange County, San Francisco Bay Area, and Toronto. CCRM Fertility is a proud strategic partner of Unified Women's Healthcare, the leading platform for women's health services. Together with our affiliated providers and businesses, we anticipate the greatest opportunities to impact every woman's health at every stage of her journey and are unparalleled in our scale and ability to adapt to address unmet and underserved needs. For more information, visit . SOURCE CCRM

PROFILE is the first prospective, multi-national, observational, real-world study of Rekovelle in clinical practice, conducted in more than 940 women from 10 countries across Europe, North America and Australia. This study provides evidence of the effectiveness of Rekovelle across a broad range of patients in a real-world clinical setting and supports its efficacy and safety profile, as previously demonstrated in randomised controlled trials (RCTs). 1-4 In the study, 74.0% of patients had between 4 and 19 oocytes retrieved and the ongoing pregnancy rates were similar to Phase 3 RCTs.1-3 Rekovelle is the only recombinant follicle-stimulating hormone (rFSH) for ovarian stimulation (OS) that uses individualised dosing calculated through an approved algorithm based on bodyweight and anti-Müllerian hormone (AMH) levels. SAINT-PREX, Switzerland--(BUSINESS WIRE)-- Today, an oral poster of the first post-authorisation Phase 4 real-world study, PROFILE, is being presented at the 13th Congress of the Pacific Society for Reproductive Medicine (PSRM) 2023 in Australia. The large, prospective, multi-national study confirms the effectiveness and safety of Rekovelle in routine clinical practice, with ongoing pregnancy rates similar to Phase 3 RCTs.1-3,5 The study was first published in Frontiers of Endocrinology in December 2022.5 The PROFILE study enrolled 944 women who had not previously undergone in vitro fertilisation (IVF) or intracytoplasmic sperm injection (ICSI). Results highlighted that with Rekovelle, almost three-quarters (74.0%) of women had between 4-19 oocytes retrieved and 255 women (27.0%) achieved an ongoing pregnancy at 10-11 weeks after transfer. The ongoing pregnancy rate was similar to the rates observed in the Phase 3 RCTs.1–3 The first cycle cumulative ongoing pregnancy rate after fresh and/or frozen transfer was 36.4%. The research also showed a 3.9% incidence of ovarian hyperstimulation syndrome (OHSS), with most cases of OHSS being of mild to moderate intensity, (n=30 [3.2%]) and all participants with OHSS made a full recovery.5 “Up to now, we have more than 2,000 patients in the RCTs for Rekovelle – ESTHER-1 and -2, GRAPE and STORK trials – but these had strict inclusion and exclusion criteria. Real-world data extends efficacy and safety data to all patients. In fact, in PROFILE there were nearly no restrictions other than that the participants were seeking to become pregnant, had no contraindications to rFSH, and had not previously undergone ovarian stimulation,” said Professor Christophe Blockeel, from Brussels IVF, the Centre for Reproductive Medicine, Universitair Ziekenhuis Brussel and Vrije Universiteit Brussel, who was the principal investigator of the PROFILE study. In countries where it is licensed, Rekovelle is the only rFSH for OS that has an individualised fixed daily dose calculated using an approved algorithm based on bodyweight and levels of AMH. AMH is a biomarker used to predict ovarian response.6 In PROFILE, physicians used the Rekovelle dosing algorithm for nearly all participants (95%), although some made minor adjustments to the prescribed starting dose or adjusted the dose during OS based on clinical factors. Adverse drug reactions (ADRs) were monitored for all initiated OS cycles, and the number of ADRs leading to treatment and study discontinuation was low (n=4). “Ferring is committed to building healthy families of every shape and size by developing innovative fertility treatments. We are committed to seeking insights throughout the research and development of our treatments, so it is therefore encouraging to see that in an observational study of real-world clinical practice, Rekovelle confirmed its effectiveness through ongoing pregnancy rates, similar, or higher than RCTs,” said Christina Lloyd, Senior Vice President and Head of Reproductive Medicine and Maternal Health, Ferring Pharmaceuticals. - ENDS - About the PROFILE study In the PROFILE study (Prospective multicentre non-interventional study to assess the patterns of use of Rekovelle in women undergoing in vitrO Fertilisation or Intracytoplasmic sperm injection procedures in routine clinicaL practicE), 1,258 women were screened between March 2018 and October 2020, and 1,013 met the inclusion and exclusion criteria. A total of 944 participants initiated their first OS cycle at 34 specialist fertility clinics across Australia, Austria, Belgium, Canada, Germany, Italy, Netherlands, Poland, Spain and UK in which Rekovelle is licensed. The primary endpoint was the real-world treatment patterns of follitropin delta, including starting daily dose, number of days of treatment, deviations from the approved dosing schedule as per the summary of product characteristics (per-label), use of dosing algorithm, and use of other treatments during OS, such as GnRH protocol, triggering methods of follicle maturation and luteal phase support. Secondary endpoints included cycle cancellations, pregnancy outcomes for Cycle 1, and OHSS and other ADRs for all initiated cycles. Participants could initiate up to three OS cycles with Rekovelle; however, utility and effectiveness data were only analysed for Cycle 1 as the study was terminated early due to the COVID-19 pandemic, during which many fertility clinics closed or provided reduced services. Real-World Utilisation Patterns of Rekovelle The study aimed to observe the real-world utilisation patterns, effectiveness, and safety pro follitropin delta in women ≥18 years naïve to OS undergoing IVF or ICSI. According to the data collected during the study, most participants received Rekovelle as specified in the approved label without dose deviations. In PROFILE, nearly all patients (95%) had their starting dose calculated using the algorithm, although some physicians then made minor adjustments to the prescribed starting dose during the OS cycle based on clinical factors. “We wanted to know if physicians are really using the dosing algorithm, and the answer is yes, the vast majority did. I think this really reflects how Rekovelle is being used in the real world and physicians are using the algorithm in those countries where it is approved,” said Professor Blockeel. In PROFILE, the mean total dose of follitropin delta was slightly higher than observed in randomised clinical trials, reflecting differences in bodyweight and AMH levels of the participants.1-5 The PROFILE study had no enrolment restrictions for bodyweight or AMH levels, and the overall study population had a higher mean bodyweight and had lower or comparable median AMH levels than the RCT cohorts.1-3,5 Adverse Drug Reactions ADRs were monitored for all initiated OS cycles (1,130 cycles for 944 participants). Forty-nine participants (5.2%) reported 58 ADRs. The number of ADRs leading to treatment and study discontinuation was low (four participants experiencing six ADRs: OHSS, n=2 events; vomiting, n=1 event; headache, n=1 event; rash, n=1 event and premature ovulation, n=1 event). The most frequent ADR was any grade of ovarian hyperstimulation syndrome (OHSS; n=37 [3.9%]), which was similar to the incidence of OHSS in the Rekovelle arm during the first cycle of the RCT ESTHER-1 (3.5%).1 In the PROFILE study, most cases of OHSS were of mild or moderate intensity (n=30 [3.2%]) and all participants with OHSS made a full recovery. About Rekovelle (follitropin delta) Rekovelle is a human rFSH with an approved dosing algorithm designed for a predictable ovarian response.7 It is the first rFSH derived from a human cell line (PER.C6® cell line). Rekovelle is structurally and biochemically distinct from other existing rFSH gonadotrophins.7, 8 Rekovelle is approved in certain markets for use in OS for induction of the development of multiple follicles in women undergoing assisted reproductive technologies (ART), such as IVF or ICSI. The individualised dosing of Rekovelle is determined using an approved algorithm, based on a woman’s AMH level and body weight.7-9 AMH is a biomarker used to assess ovarian reserve and can help predict ovarian response.6 The Rekovelle dose should be based on AMH level, measured using the ELECSYS AMH Plus immunoassay from Roche, the ACCESS AMH Advanced from Beckman Coulter, or LUMIPULSE G AMH from Fujirebio.7 Rekovelle is not approved in all markets. About Ferring Pharmaceuticals Ferring Pharmaceuticals is a research-driven, specialty biopharmaceutical group committed to helping people around the world build families and live better lives. Headquartered in Saint-Prex, Switzerland, Ferring is a leader in reproductive medicine and maternal health, and in specialty areas within gastroenterology and urology. Ferring has been developing treatments for mothers and babies for over 50 years and has a portfolio covering treatments from conception to birth. Founded in 1950, privately-owned Ferring employs over 7,000 people worldwide. The company has operating subsidiaries in more than 50 countries and markets its products in over 100 countries. Learn more at , or connect with us on Twitter, Facebook, Instagram, LinkedIn and YouTube. References 1. Nyboe Andersen A, Nelson SM, Fauser BC, Garcia-Velasco JA, Klein BM, Arce JC, et al. Individualized versus conventional ovarian stimulation for in vitro fertilization: a multicenter, randomized, controlled, assessor-blinded, phase 3 noninferiority trial. Fertil Steril. 2017 Feb;107(2):387-96 e4. PubMed PMID: 27912901. Epub 2016/12/04. 2. Qiao J, Zhang Y, Liang X, Ho T, Huang HY, Kim SH, et al. A randomised controlled trial to clinically validate follitropin delta in its individualised dosing regimen for ovarian stimulation in Asian IVF/ICSI patients. Hum Reprod. 2021 Jun 28;36(9):2452-62. PubMed PMID: 34179971. Epub 2021/06/29. 3. Ishihara O, Arce JC, Japanese Follitropin Delta Phase 3 Trial G. Individualized follitropin delta dosing reduces OHSS risk in Japanese IVF/ICSI patients: a randomized controlled trial. Reprod Biomed Online. 2021 May;42(5):909-18. PubMed PMID: 33722477. Epub 2021/03/17. 4. Bosch E, Havelock J, Martin FS, Rasmussen BB, Klein BM, Mannaerts B, et al. Follitropin delta in repeated ovarian stimulation for IVF: a controlled, assessor-blind phase 3 safety trial. Reprod Biomed Online. 2019 Feb;38(2):195-205. PMID: 30594482. Epub 2018/12/14. 5. Blockeel C, Griesinger G, Rago R, Larsson P, Sonderegger YLY, Rivière S, et al. Prospective multicenter non-interventional real-world study to assess the patterns of use, effectiveness and safety of follitropin delta in routine clinical practice (the PROFILE study). Frontiers in Endocrinology. 2022 Dec 22;13:992677. PMID: 36619578. 6. Arce JC, La Marca A, Mirner Klein B, Nyboe Andersen A, Fleming R. Antimullerian hormone in gonadotropin releasing-hormone antagonist cycles: prediction of ovarian response and cumulative treatment outcome in good-prognosis patients. Fertil Steril. 2013 May;99(6):1644-53. PubMed PMID: 23394782. Epub 2013/02/12. 7. Follitropin Delta (Rekovelle) Summary of Product Characteristics. Date of publication 2016. Approved on 12 December 2016 and last updated on the EMA website in March 2022. Available from [Accessed March 2023]. 8. Olsson H, Sandstrom R, Grundemar L. Different pharmacokinetic and pharmacodynamic properties of recombinant follicle-stimulating hormone (rFSH) derived from a human cell line compared with rFSH from a non-human cell line. J Clin Pharmacol. 2014 Nov;54(11):1299-307. PubMed PMID: 24800998. Epub 20140521. 9. Arce JC, Andersen AN, Fernandez-Sanchez M, Visnova H, Bosch E, Garcia-Velasco JA, et al. Ovarian response to recombinant human follicle-stimulating hormone: a randomized, antimullerian hormone-stratified, dose-response trial in women undergoing in vitro fertilization/intracytoplasmic sperm injection. Fertil Steril. 2014 Dec;102(6):1633-40 e5. PubMed PMID: 25256937. Epub 2014/09/27. ### View source version on businesswire.com: Contacts For more information, please contact Amy Cheshire Director, Corporate Communications Amy.Cheshire@ferring.com Samara Barr Account Manager, Syneos Health Communications PR Europe +44 (0)7935 076261 (mobile) Samara.Barr@syneoshealth.com Source: Ferring Pharmaceuticals View this news release online at:

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. SOURCE Gameto