Pregnancy rate

Femasys Announces Positive Topline Data from Pivotal Trial for its FDA-Cleared FemaSeed® for the Treatment of Infertility

Retrieved on: 
Wednesday, March 20, 2024
Infertility, TMSC, Pregnancy rate, IVF, IUI, Pregnancy, Fertilisation, Woman, Male, Safety, Literature, FDA, ICSI, Insemination, Physician, Birth control

ATLANTA, March 20, 2024 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a leading biomedical company focused on addressing significant unmet needs of women worldwide with a broad portfolio of in-office, accessible, and innovative therapeutic and diagnostic products, today announces topline data from its FemaSeed Localized Directional Insemination for artificial insemination pivotal trial (NCT04968847). The trial investigated its FemaSeed product in women with a variety of infertility factors with the primary efficacy analysis focused on the severe male factor infertility. FemaSeed, engineered to enhance fertilization by precisely delivering sperm into the fallopian tube, the site of conception, demonstrated 24% of women became pregnant after FemaSeed with severe male factor (1 million to 20 million total motile sperm count (TMSC)). In contrast, a 6.7% pregnancy rate by cycle was described in the literature for intrauterine insemination (IUI) with male factor (greater than 1 million TMSC).1 Although permitted to have multiple FemaSeed attempts, the majority of women who became pregnant did so after the first FemaSeed procedure. The poor IUI pregnancy rates for this infertility segment usually necessitates assisted reproductive approaches, such as in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI).

Key Points: 
  • The trial investigated its FemaSeed product in women with a variety of infertility factors with the primary efficacy analysis focused on the severe male factor infertility.
  • “These impressive topline results for our now FDA-cleared FemaSeed, demonstrate significant progress in the treatment of infertility, while confirming its safety profile.
  • “The pivotal trial amassed substantial prospective data in support of the safety and efficacy of FemaSeed as a groundbreaking advancement in artificial insemination.
  • The pivotal trial was concluded prior to completing full enrollment due to Femasys receiving FDA clearance for FemaSeed under the 510(k) pathway in September 2023.

Maintaining optimism in a crisis-marked year: Plan International Canada releases 2023 Annual Report outlining impact for children around the world

Retrieved on: 
Monday, January 15, 2024
Woman, Pregnancy rate, Annual report, Health, Amazon, Female, Birth, Optimism, Climate change, Safety, COVID-19, Violence, Masculinity, The Annual Report, Education, Birth control

"Global crises like conflict and climate change have caused life-changing upheaval for communities that were already suffering the aftershocks of COVID-19," said Lindsay Glassco, President and CEO of Plan International Canada.

Key Points: 
  • "Global crises like conflict and climate change have caused life-changing upheaval for communities that were already suffering the aftershocks of COVID-19," said Lindsay Glassco, President and CEO of Plan International Canada.
  • "For children, and particularly girls, this has meant continued disruptions to their fundamental rights, including education, safety, and health.
  • We have confronted these challenges with determined optimism to achieve momentous impact for children, girls and their communities.
  • Plan International Canada is an international humanitarian and development organization working to advance children's rights and equality for girls.

Femasys Inc. Announces Financial Results for the Second Quarter Ended June 30, 2023 and Provides Corporate Update

Retrieved on: 
Thursday, August 10, 2023
Patent, Insurance, Investigational device exemption, Office of Criminal Investigations, Research and development, Marketing, Public Health Agency of Canada, Woman, Audit committee, Anesthesia, IDE, FDA, Therapy, Health Canada, Pregnancy rate, Public Health Agency, First Ever, Safety, Nursing, Pharmaceutical industry, Cryptocurrency

ATLANTA, Aug. 10, 2023 (GLOBE NEWSWIRE) -- Femasys Inc. (NASDAQ: FEMY), a biomedical company focused on meeting women’s unmet needs worldwide by developing a broad portfolio of innovative product candidates and products that include minimally invasive, in-office technologies for reproductive health, today announced financial results for the second quarter ended June 30, 2023 and provided a corporate update.

Key Points: 
  • Femasys expects the resulting patent, when issued, will have an anticipated expiration in 2039 at the earliest.
  • Sales increased by $17,401 to $320,514 for the three months ended June 30, 2023 compared to $303,113 for the same period in 2022.
  • Gross margin percentage was 65.5% for the three months ended June 30, 2023 as compared to 66.2% for the three months ended June 30, 2022.
  • Gross margin percentage was 64.9% for the six months ended June 30, 2023 as compared to 64.0% for the same period in 2022.

Beverly Hills Fertility (BHF) Pioneers Personalized Cryopreservation Protocols to Revolutionize Fertility Industry

Retrieved on: 
Thursday, August 3, 2023
REI, Communication, Reproductive medicine, Pregnancy, PGT, QC, Incubator, Oocyte, BHF, Survival, Hope, Infertility, Ovarian reserve, Research, Toxicity, Medicine, Cell, Fertilisation, IVF, Cryopreservation, Fertility, SOP, Patient, Freezing, Cryobiology, Algorithm, ICSI, Reading, CPA, Diagnosis, AI, BMI, Pregnancy rate, Standard operating procedure, Biopsy, Egg, Medical device, Mineral oil

Dr. Liu, BHF's skilled IVF lab director, stands out for his unwavering commitment to personalized protocols, setting BHF apart from other reproductive clinics.

Key Points: 
  • Dr. Liu, BHF's skilled IVF lab director, stands out for his unwavering commitment to personalized protocols, setting BHF apart from other reproductive clinics.
  • Embracing the concept of customized cryopreservation protocols in the era of personalized medicine can significantly enhance success rates.
  • Beverly Hills Fertility (BHF) recognizes the potential of AI applications in IVF clinics to enhance personalized approaches, which has already been proven successful at BHF.
  • Looking ahead, the future of cryopreservation appears promising, envisioning a world where personalized medicine becomes the norm.

New Study Shows Acupuncture Enhances Pregnancy Outcomes in Women Undergoing In Vitro Fertilization

Retrieved on: 
Tuesday, July 18, 2023
Olive, Systematic review, Pregnancy, LBR, Embryo transfer, Woman, Infertility, Meta-analysis, Fertilisation, IVF, Synthetic control method, Patient, Transcutaneous electrical nerve stimulation, LLLT, CPR, Traditional Chinese medicine, Pregnancy rate, Medical device, Birth control, Health care, Acupuncture

VANCOUVER, British Columbia, July 18, 2023 /PRNewswire-PRWeb/ -- A comprehensive systematic review and meta-analysis, conducted by researchers Menghao Xu, Mengdi Zhu, and Cuihong Zheng, has revealed the positive effects of acupuncture on pregnancy outcomes in women undergoing in vitro fertilization (IVF). The study, which was recently published in a leading scientific journal, sheds light on the benefits of acupuncture as an adjunctive therapy in assisted reproductive technology.

Key Points: 
  • The study, encompassing 25 trials with 4757 participants, demonstrated higher clinical pregnancy and live birth rates among acupuncture groups compared to control groups.
  • VANCOUVER, British Columbia, July 18, 2023 /PRNewswire-PRWeb/ -- A comprehensive systematic review and meta-analysis, conducted by researchers Menghao Xu, Mengdi Zhu, and Cuihong Zheng, has revealed the positive effects of acupuncture on pregnancy outcomes in women undergoing in vitro fertilization (IVF).
  • The study , encompassing data from 25 trials with a total of 4757 participants, examined the impact of acupuncture on IVF-FET (in vitro fertilization and embryo transfer) outcomes.
  • According to the researchers, these findings suggest that acupuncture can play a significant role in improving pregnancy outcomes for women undergoing IVF.

ObsEva Recovers Full Worldwide Rights on Nolasiban

Retrieved on: 
Thursday, July 13, 2023
SIX Swiss Exchange, Human, Embryo transfer, Woman, ART, Meta-analysis, Sale, IVF, Patient, Fertility, Health, Pregnancy rate, Birth control

In January 2020, ObsEva granted to Yuyuan an exclusive sublicense to use, register, import, develop, market, promote, distribute, offer for sale, and commercialize nolasiban for use in humans in the People’s Republic of China, including Hong Kong and Macau.

Key Points: 
  • In January 2020, ObsEva granted to Yuyuan an exclusive sublicense to use, register, import, develop, market, promote, distribute, offer for sale, and commercialize nolasiban for use in humans in the People’s Republic of China, including Hong Kong and Macau.
  • The terms of the sub-licensing agreement provided ObsEva with rights to terminate the agreement with immediate effect subject to certain development milestones not being met by Yuyuan within certain deadlines.
  • Under these terms, on July 12, 2023, ObsEva decided to notify Yuyuan of its breach to comply with certain set milestones and the license rights on nolasiban previously granted to Yuyuan forthwith reverted to ObsEva.
  • “With one third of the ART cycles worldwide, China is a key market in fertility, and recovering the Chinese rights of nolasiban is a significant opportunity for ObsEva to address the huge unmet medical need in IVF and its global commercial potential.” said Fabien de Ladonchamps, Chief Executive Officer.

Fairtility Unveils CHLOE OQ™ Expanding its Offering into Fertility Preservation

Retrieved on: 
Monday, June 26, 2023
CE, Pregnancy, ESHRE, Life, Oocyte, Woman, Fertilisation, Fertility clinic, IVF, Egg donation, TEL, Fertility preservation, Patient, Fertility, Biology, Human Reproduction (journal), Entrepreneurship, European Society of Human Reproduction and Embryology, Reproduction, Myllocerus discolor, Pregnancy rate, Egg, Mineral oil, Medical device

TEL AVIV, Israel, June 26, 2023 /PRNewswire/ -- Fairtility, the transparent AI innovator powering reproductive care for improved outcomes, today announced the launch of CHLOE OQ™, bringing Oocyte Quality Insights to CHLOE's core technology suite of capabilities and expanding the applicability of its AI-driven decision support tool to fertility preservation. The solution will be unveiled at the 39th Annual Meeting of the European Society of Human Reproduction and Embryology (ESHRE) being held in Copenhagen, Denmark from June 25 to 28, 2023.

Key Points: 
  • With CE declared for CHLOE OQ™, the new Oocyte Quality Insights capability offers IVF professionals comprehensive information to support decision making as patients undergo fertility preservation or assisted reproductive journeys.
  • However, assessing oocyte quality has remained a statistical gamble," said Dr. Cristina Hickman, Chief Clinical Officer of Fairtility.
  • Egg Donation: CHLOE OQ helps fertility clinics and egg banks to further assess the quality of donor eggs, ensuring equitable distribution to recipients.
  • CHLOE OQ now provides decision support for fertility preservation, egg donation, and female-factor infertility in IVF treatment.

May Health Announces Data From Feasibility Studies of its Novel Ovarian Rebalancing™ Treatment and Receives Approval From FDA for Pivotal Trial

Retrieved on: 
Monday, June 26, 2023
Research, Medical Devices, Women, FDA, Baby, Maternity, Clinical Trials, Health, Consumer, Science, Vaginal bleeding, Area studies, ULTRA, Pregnancy, University, Ovary, Sofinnova, Ovulation, Food and Drug Administration, Clinical trial, Woman, Infertility, Polycystic ovary syndrome, Ultrasound, Pain, Patient, PCOS, Reproductive medicine, Headache, Pregnancy rate, Food, Safety, Birth control, Pharmaceutical industry

Early outcomes data from the ULTRA-EU and ULTRA-US feasibility clinical trials were presented at the 39th Annual ESHRE meeting in Copenhagen, Denmark on June 26, 2023.

Key Points: 
  • Early outcomes data from the ULTRA-EU and ULTRA-US feasibility clinical trials were presented at the 39th Annual ESHRE meeting in Copenhagen, Denmark on June 26, 2023.
  • "The new data show great promise for Ovarian Rebalancing as a safe and effective office-based treatment to induce ovulation in women who have not achieved results from first-line medications."
  • "The success of these feasibility studies and the FDA's approval of the pivotal REBALANCE study only serve to reinforce our initial conviction.
  • Details of the oral presentation:
    Title: The ULTRA trial: transvaginal ULTRAsound-guided ovarian ablation using the novel May Health device in women with PCOS-related infertility: first–in-human feasibility clinical trial

Ferring Announces Abstract of the First Prospective, Multi-National, Real-world Study of Rekovelle® (follitropin delta) at the Congress of the Pacific Society for Reproductive Medicine

Retrieved on: 
Monday, March 13, 2023
Health, Pharmaceutical, Woman, IVF, Phase 3, Research, Contraindication, OS, ADR, Senior, Pregnancy, Maternal health, Reproductive medicine, Ferring Pharmaceuticals, GRAPE, OHSS, RCT 1, Observational study, Patient, Pregnancy rate, Congress, Frontiers in Endocrinology, PSRM, Ovarian hyperstimulation syndrome, Adverse drug reaction, Isabella Tree, Safety, Vrije Universiteit Brussel, Incidence, ICSI, Physician, Pacific Society for Reproductive Health Trust, AMH, Oocyte, Pharmaceutical industry, Birth control, Gonadotropin preparations, Endocrinology

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.

Key Points: 
  • 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.
  • 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.
  • 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.

Femasys Inc. Announces Enrollment is over 25% Complete for FemaSeed® De Novo Trial Following Updated Strategic Study Design

Retrieved on: 
Tuesday, November 29, 2022
Tubing (recreation), IVF, Prevalence, Reproductive health, Safety, De novo, Pregnancy rate, Annual report, Male, Risk, Infertility, Clinical trial, Woman, FDA, Birth control

FemaSeed is the first and only first-line approach in development designed to deliver sperm directly to where conception occurs.

Key Points: 
  • FemaSeed is the first and only first-line approach in development designed to deliver sperm directly to where conception occurs.
  • After announcing our updated strategic trial design only a month ago, we are thrilled to have reached over 25% of our targeted 214 FemaSeed cycles.
  • In October, the Company announced an updated study design for this trial, which is now focused on couples experiencing male factor infertility.
  • Results from the trial will support a future de novo authorization by the FDA for FemaSeed.