INVO Bioscience wins FDA de novo approval for InvoCell

INVO Bioscience said yesterday it won FDA de novo approval for its INVOcell intravaginal culture infertility treatment system. The company said it is the 1st intravaginal culture system with marketing clearance in the U.S. INVOcell is designed for incubating eggs and sperm during fertilization during early embryo development and operates within a woman’s body, unlike in vitro fertilization which takes place in a laboratory, the company said. “INVOcell has the ability to significantly transform the way in which fertility clinics across the United States assist infertile patients to achieve their desired outcomes in a simpler, more natural and cost effective manner. It has been a long process to de novo clearance and we are so pleased to have this approval from the FDA to begin marketing and selling in the United States. With this critical approval, we look forward to developing the partnerships necessary to bring this device to millions of patients across the United States,” CEO Katie Karloff said in a press release. INVO Bioscience said that clinical studies of the INVOcell showed pregnancy rates equivalent to traditional in vitro fertilization treatments. ” My goal was to create an alternative treatment to traditional IVF procedures that could produce the desired results in a simpler and more cost effective manner to allow treatment to many more infertile couples. I believe the INVOcell procedure has the ability to s...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Food & Drug Administration (FDA) Regenerative Medicine Regulatory/Compliance Women's Health INVO Bioscience Source Type: news

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This is a case series reporting live births following in vitro fertilization (IVF) after fertility-sparing surgery in patients with borderline ovarian tumors (BOTs). Seventeen patients, in whom fertility-sparing surgery for BOTs followed by IVF was performed from July 1, 2011 to September 30, 2017, in our IVF center, were included. Here we retrospectively present their BOT characteristics and clinical outcomes of assisted reproduction technology (ART) and then discuss the literature on management of patients with BOTs after fertility-sparing surgery. The study sample of 17 patients started IVF-assisted reproduction within ...
Source: Gynecologic and Obstetric Investigation - Category: OBGYN Source Type: research
Publication date: Available online 19 February 2019Source: Journal of Minimally Invasive GynecologyAuthor(s): Keiji Kuroda, Yuko Ikemoto, Asako Ochiai, Rie Ozaki, Yuko Matsumura, Shuko Nojiri, Koji Nakagawa, Rikikazu SugiyamaABSTRACTStudy ObjectiveTo analyze the clinical outcomes and predictive factors for the therapeutic effect of combination treatment of preoperative embryo cryopreservation and endoscopic surgery (‘surgery-assisted reproductive technology [ART] hybrid therapy’) in infertile women with diminished ovarian reserve (DOR) with uterine fibroids and/or ovarian endometriomas.DesignA retrospective coh...
Source: Journal of Minimally Invasive Gynecology - Category: OBGYN Source Type: research
Introduction: Either appearing after miscarriage or abortion by request, the trophoblastic retention is often easy to diagnose, but the management can be difficult. Therefore, severe consequences may appear: endometritis, infertility, intrauterine adhesions, persistent molar pregnancy.
Source: European Journal of Obstetrics, Gynecology, and Reproductive Biology - Category: OBGYN Authors: Tags: Oral Poster at Breakfast 7 – EARLY PREGNANCY LOSS and ECTOPIC Source Type: research
Introduction: Recurrent pregnancy loss represents a major health problem and is  one of the most common causes of female infertility. The association between thrombophilia and recurrent pregnancy loss (RPL) has become an undoubted fact
Source: European Journal of Obstetrics, Gynecology, and Reproductive Biology - Category: OBGYN Authors: Tags: Session 22 – Early Pregnancy, intrauterine insemination and PCOS Source Type: research
Introduction: Endometriosis is an enigmatic disease affecting up to 10% of reproductive-aged women causing pain and infertility. Deep infiltrating endometriosis (DIE) is the most severe form of the disease. The impact of surgical treatment for deep endometriosis on fertility success rate of assisted reproduction techniques (ART) is not clear.
Source: European Journal of Obstetrics, Gynecology, and Reproductive Biology - Category: OBGYN Authors: Tags: Session 24 – Reproductive Medicine Source Type: research
Introduction: Since 2000, the Donor Sibling Registry (DSR) has connected more than 15,500 donor offspring with half-siblings and their biological parents. Accordingly, they have been able to create and explore these new familial relationships and can also understand their ancestry and learn about their medical backgrounds. 56,000 gamete donors, offspring, and recipients in 105 countries have registered on the DSR, seeking to find those with whom they share genetic ties.
Source: European Journal of Obstetrics, Gynecology, and Reproductive Biology - Category: OBGYN Authors: Tags: Session 24 – Reproductive Medicine Source Type: research
Introduction: There is a high frequency of subclinical forms of thyroid pathology, prevalence of infertility, miscarriage, but there is no single one thought about the need for screening programs, tactics of preconceptual training.
Source: European Journal of Obstetrics, Gynecology, and Reproductive Biology - Category: OBGYN Authors: Tags: Basic Science 3 – Obstetrics and Caring for women in distress Source Type: research
Introduction: Submucosal fibroids result in abnormal uterine bleeding and infertility leading to hysteroscopic resections. The data on whether submucous fibroids should be removed is conflicting. The Cochrane dated February 2015 suggests that there is not enough evidence to recommend routing hysteroscopic resection of submucous fibroids. The AAGL (American Association of Gynecologic Laparoscopists) recommends the removal of submucous fibroids in infertility and in selected patients with abnormal uterine bleeding and recurrent pregnancy loss.
Source: European Journal of Obstetrics, Gynecology, and Reproductive Biology - Category: OBGYN Authors: Tags: Session 40 – Innovation and technology Source Type: research
(Natural News) Those of us who have children can likely remember the incredible excitement we felt the day the pregnancy test came back positive. Sadly, that joy eludes many desperate couples. The Centers for Disease Control and Prevention (CDC) confirms that 12.1 percent of women in the U.S. face fertility issues, with virtually all of...
Source: NaturalNews.com - Category: Consumer Health News Source Type: news
Recently Discovered Interstitial Cell Population of Telocytes: Distinguishing Facts from Fiction Regarding Their Role in the Pathogenesis of Diverse Diseases Called "Telocytopathies". Medicina (Kaunas). 2019 Feb 18;55(2): Authors: Varga I, Polák Š, Kyselovič J, Kachlík D, Danišovič Ľ, Klein M Abstract In recent years, the interstitial cells telocytes, formerly known as interstitial Cajal-like cells, have been described in almost all organs of the human body. Although telocytes were previously thought to be localized predominantly in the organs of the digestive ...
Source: Medicina (Kaunas) - Category: Universities & Medical Training Authors: Tags: Medicina (Kaunas) Source Type: research
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