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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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I often see lots of infertile patients who could get pregnant if they did IVF treatment. Unfortunately, they just cannot afford to do an IVF cycle for financial reasons, and they end up without a baby. It fair to say  that  this causes them a significant amount of  frustration and heartburn when you know that IVF can help you get pregnant; but you can ’t, because you just can’t afford the treatment.Can this be changed? But it ’s not just the patients who are affected; IVF specialists also go through a lot of anguish when this happens. It’s very difficult to come to terms with the...
Source: Dr.Malpani's Blog - Category: Reproduction Medicine Source Type: blogs
Publication date: Available online 18 May 2018 Source:Middle East Fertility Society Journal Author(s): Vasudha Gupta, Gita Radhakrishnan, Vinod Arora, Alpana Singh Objective Evaluation of endometrial scratching on pregnancy rates after IUI and comparing levels and distribution of IL-6 (inflammatory molecule) and E-Cadherin (adhesion molecule) by immunohistochemistry. Study design Randomized case control study. Setting Tertiary care hospital of Delhi, India. Material and methods 240 women (120 in each group) with previous failed IUI cycles were enrolled. Study group patients were subjected to endometrial scratch by “...
Source: Middle East Fertility Society Journal - Category: Reproduction Medicine Source Type: research
Conclusion Calcium infusion is more effective than oral cabergoline intake from OPU day in the reduction of OHSS overall incidence as well as its severity with comparable pregnancy outcomes. Trial registration: https://clinicaltrials.gov/ct2/show/NCT03473613.
Source: Middle East Fertility Society Journal - Category: Reproduction Medicine Source Type: research
This study evaluated the changes in seminal oxidative stress status, inflammatory biomarkers, semen parameters, sperm DNA integrity and pregnancy rate following 24 weeks of resistance exercise in infertile patients. A total of 1228 sedentary infertile patient (aged 25–40 years) were screened and 430 were randomized to exercise (EX, n = 216) and non-exercise (NON-EX, n = 214) groups. Semen samples were taken before, 12 and 24 weeks as well as 7 and 30 days during recovery. Key findings Exercise intervention favorably attenuated inflammation as indicated by seminal cytokines (IL-1β, IL-6, IL-8 and ...
Source: Life Sciences - Category: Biology Source Type: research
Conclusions: Although anti-Müllerian hormone values and antral follicle count were higher than the low thresholds, a statistically significant decline of ovarian reserve in the unexplained infertility group was found in the present study. This might be an undiagnosed reason for unexplained infertility. PMID: 29765438 [PubMed]
Source: Archives of Medical Science - Category: General Medicine Tags: Arch Med Sci Source Type: research
Study also links women ’s use of non-SSRI antidepressants to early pregnancy loss.
Source: National Institutes of Health (NIH) News Releases - Category: American Health Source Type: news
Women having trouble getting pregnant sometimes try yoga, meditation or mindfulness, and some research suggests that psychological stress may affect infertility. But what about men: Does their mental state affect a couple's ability to conceive? The latest research on this subject was published Thursday in the journal Fertility and Sterility and suggests that a link between mental health […]Related:CDC comes close to an all-clear on romaine lettuce as E. coli outbreak nears historic levelSurrogate mothers ask Supreme Court to stop ‘exploitation’ of women and babiesMore men with low-risk pro...
Source: Washington Post: To Your Health - Category: Consumer Health News Source Type: news
Women having trouble getting pregnant sometimes try yoga, meditation or mindfulness, and some research suggests that psychological stress may affect infertility. But what about men: Does their mental state affect a couple's ability to conceive? The latest research on this subject was published Thursday in the journal Fertility and Sterility and suggests that a link between mental health […]Related:CDC comes close to an all-clear on romaine lettuce as E. coli outbreak nears historic levelSurrogate mothers ask Supreme Court to stop ‘exploitation’ of women and babiesMore men with low-risk pro...
Source: Washington Post: To Your Health - Category: Consumer Health News Source Type: news
(NIH/Eunice Kennedy Shriver National Institute of Child Health and Human Development) Among couples being treated for infertility, depression in the male partner was linked to lower pregnancy chances, while depression in the female partner was not found to influence the rate of live birth, according to a study funded by the National Institutes of Health.The study, which appears in Fertility and Sterility, also linked a class of antidepressants known as non-selective serotonin reuptake inhibitors (non-SSRIs) to a higher risk of early pregnancy loss among females being treated for infertility.
Source: EurekAlert! - Medicine and Health - Category: International Medicine & Public Health Source Type: news
AbstractPurpose of ReviewMen with spinal cord injury (SCI) commonly suffer from erectile dysfunction and ejaculatory dysfunction. The literature regarding the causes and treatment of these two important problems was reviewed.Recent FindingsMany of the erectile dysfunction treatments applied to able bodied individuals are also useful in the SCI population, although there are differences in the goals and results of treatment. Ejaculatory dysfunction can be treated with either penile vibratory stimulation or electroejaculation with high success rates. Pregnancies are possible, but poor quality sperm quality in male SCI patien...
Source: Current Urology Reports - Category: Urology & Nephrology Source Type: research
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