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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Conclusions: All breakpoints at chromosome 2 were correlated with gestational infertility. Carriers of chromosome 2 translocations should therefore receive counseling to continue with natural conception and use of different technologies available via assisted reproductive technology, such as preimplantation genetic diagnosis.
Source: International Braz J Urol - Category: Urology & Nephrology Source Type: research
in India is blindly trusting the IVF doctorIt ’s extremely important that you find a doctor you can trust – and it’s equally that you make sure that he earns that trust ! Trust is too important to be gifted to anyone .Sadly, the government does a poor job of regulating IVF clinics, which means there are many fly by night operators who just want to exploit patients. And it's easy to do this because infertile patients are ignorant and vulnerable.The trust equation , as defined by David Maister, says that the doctor must prove that he is reliable and credible – and you need to check this before signin...
Source: Dr.Malpani's Blog - Category: Reproduction Medicine Source Type: blogs
Abstract Psychosocial aspects of fertility, infertility, and assisted reproductive technology (ART) can significantly impact patients' sense of self-identity and personal agency, mental well-being, sexual and marital relationships, reproductive efficiency, compliance with treatment, and pregnancy outcomes. Research is needed to understand how stress, anxiety, depression, mood disorders, and psychotropic medications impact fertility and infertility treatment. The psychosocial implications of ART on our society include a shift toward older maternal age at conception, the complexities of third-party reproduction, and...
Source: The Medical Clinics of North America - Category: General Medicine Authors: Tags: Obstet Gynecol Clin North Am Source Type: research
Pregnancy after infertility is a challenging experience. The first-trimester screening test may add stress. Partner support reduces psychological distress in pregnant women after spontaneous conception. No data are available for women who conceive via assisted reproductive technology.
Source: Women and Birth - Category: Midwifery Authors: Source Type: research
Publication date: Available online 29 November 2017Source: PhytomedicineAuthor(s): Sharanbasappa Durg, Shivakumar Badamaranahalli Shivaram, Sachin BavageAbstractBackground: Withania somnifera Dunal, commonly known as Indian ginseng, has been in use since ancient times as anti-stress agent, aphrodisiac, for impotence and infertility treatment.Purpose: To evaluate the efficacy and safety of W. somnifera treatment in infertile men.Study design: An evidence-based systematic review and meta-analysis using Preferred Reporting Items for Systematic reviews and Meta-Analyses (PRISMA) guidelines.Methods: published literature was sea...
Source: Phytomedicine - Category: Drugs & Pharmacology Source Type: research
India is still a developing country and most patients are quite poor. Infertile patients find it very hard to afford test tube baby treatment , because insurance doesn't cover for it, and they need to pay for it out of their pocket. And since they're never really sure whether the IVF cycle is going to work or not , so mentally they have to be prepared for making maybe two, three, or more attempts, until they finally get a baby.This is why they worry a lot about the cost – can they afford it ?The trouble is that a lot of IVF clinics aren't very up-front, transparent, or open about this important issue, because th...
Source: Dr.Malpani's Blog - Category: Reproduction Medicine Source Type: blogs
Psychosocial aspects of fertility, infertility, and assisted reproductive technology (ART) can significantly impact patients ’ sense of self-identity and personal agency, mental well-being, sexual and marital relationships, reproductive efficiency, compliance with treatment, and pregnancy outcomes. Research is needed to understand how stress, anxiety, depression, mood disorders, and psychotropic medications impact ferti lity and infertility treatment. The psychosocial implications of ART on our society include a shift toward older maternal age at conception, the complexities of third-party reproduction, and considera...
Source: Obstetrics and Gynecology Clinics - Category: OBGYN Authors: Source Type: research
Abstract BACKGROUND: Pregnancies following assisted reproductive technology (ART) may have elevated potential risk of pregnancy loss (PL) when compared to natural conception. However, rare studies comprehensively analyzed the IVF/ICSI cycle-dependent factors for loss of clinical pregnancy. Therefore, we aimed to determine the ART subgroup-specific risks of PL throughout pregnancy and explore different risk factors for early miscarriage and late miscarriage among pregnancies conceived through ART. METHODS: A retrospective cohort study was launched in two infertility treatment centers in Nanjing and Changzhou i...
Source: Reproductive Biology - Category: Reproduction Medicine Authors: Tags: Reprod Biol Endocrinol Source Type: research
Abstract Infertility is a disease that affects up to 15.5% of reproductive-aged couples. Until the birth of the first neonate born from in vitro fertilization (IVF) in 1978, many infertile couples did not have an opportunity to conceive a biological child. Over the past 40 years, access to and effectiveness of IVF have increased; currently 1.7% of births in the United States result from IVF. As with any medical intervention, potential risk exists. In the case of IVF, both maternal risks (ovarian stimulation, oocyte retrieval, and subsequent pregnancy) and fetal risks that vary based on maternal age and fetal numbe...
Source: Obstetrics and Gynecology - Category: OBGYN Authors: Tags: Obstet Gynecol Source Type: research
Abstract The quality of oocytes depends on interactions with surrounding granulosa cells. Granulosa cells are essential in normal follicular maturation process since they produce steroidal hormones and growth factors, and they play a crucial role in follicular atresia. The success in reproductive biology and medicine depends on reliable assessment of oocyte and embryo viability which presently mainly bases on oocyte and embryo morphology. Recent investigations have tried to establish an evaluation system for oocyte quality and to predict outcome of in vitro fertilization (IVF) based on the incidence of granulosa c...
Source: Cell Biology International - Category: Cytology Authors: Tags: Cell Biol Int Source Type: research
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