FDA clears DxNow ’ s sperm separation device

Medical device developer DxNow said today it won FDA 510(k) clearance for its ZyMōt ICSI and ZyMōt multi sperm separation devices designed for use in assisted reproductive technology procedures. The newly cleared devices from the Gaithersburg, Md.-based company are designed for preparing motile sperm from semen for use in the treatment of infertile couples by intracytoplasmic sperm injection, intrauterine insemination and in vitro fertilization procedures. “We are excited to announce the achievement of this significant milestone in our company’s evolution. This announcement follows CE certification and the introduction of our sperm separation devices in Turkey and several European, Latin American and Asian countries. We have developed devices that make ART procedures faster and less demanding for reproductive medicine professionals. Equally important, we are offering a new pathway for enabling the selection of stronger and healthier sperm, with the ultimate goal of supporting infertile couples striving to conceive,” co-founder &CEO Bill Sharp said in a press release. DxNow said the devices are the first of their kind to win clearance and approval in the US. The systems are intended to simulate the cervical and uterine patheway to facilitate the separation and preparation of highly-motile sperm with normal morphology for use in ART procedures. “This is an outstanding validation of our core technology platforms. It is very gratifying to k...
Source: Mass Device - Category: Medical Devices Authors: Tags: 510(k) Food & Drug Administration (FDA) Regulatory/Compliance dxnow Source Type: news

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Psychological domain of quality of life, depression and anxiety levels in in vitro fertilization/intracytoplasmic sperm injection cycles of women with endometriosis: a prospective study. J Psychosom Obstet Gynaecol. 2020 Jul 08;:1-8 Authors: Ceran MU, Yilmaz N, Ugurlu EN, Erkal N, Ozgu-Erdinc AS, Tasci Y, Gulerman HC, Engin-Ustun Y Abstract OBJECTIVE: To evaluate the psychological domain of quality of life (PDQoL), anxiety and depression levels of infertile women with endometriosis versus non endometriosis who applied for Assisted Reproductive Technologies (ART). METHOD: This prospective case-...
Source: Journal of Psychosomatic Obstetrics and Gynaecology - Category: OBGYN Tags: J Psychosom Obstet Gynaecol Source Type: research
Intracytoplasmic sperm injection, while typically effective for overcoming low or absent fertilization in couples with a clear abnormality of semen parameters, is frequently used in combination with assisted reproductive technologies for other etiologies of infertility in the presence of semen parameters that meet the World Health Organization 2010 normative reference values. This committee opinion provides a critical review of the literature, where available, to identify situations where this may or may not be of benefit.
Source: Fertility and Sterility - Category: Reproduction Medicine Authors: Tags: ASRM pages Source Type: research
Authors: Rao M, Yang Z, Su C, Zhao Z, Wan R, Liu J, Yao Y, Su Z, Wang K, Tang L, Zhao S Abstract BACKGROUND: Maternal subclinical hypothyroidism (SCH) is a risk factor for adverse pregnancy outcomes. However, it is still unclear whether SCH affects male fertility. The aim of this study was to determine the association between paternal SCH and clinical outcomes after in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI). METHODS: This retrospective study included 2511 couples with paternal euthyroidism (n=2282) or SCH (n=229) who visited our clinic for infertility treatment between April 1, 2017 and...
Source: Thyroid : official journal of the American Thyroid Association - Category: Endocrinology Tags: Thyroid Source Type: research
Conclusion: Our study not only enriched the karyotype-phenotype correlation of Y-autosome translocation, but also strengthened the critical roles of molecular genetic techniques in identifying the chromosomal breakpoints and regions involved.
Source: Medicine - Category: Internal Medicine Tags: Research Article: Clinical Case Report Source Type: research
ConclusionDespite the widespread use of ICSI in patients without a formal diagnosis of male factor infertility, evidence demonstrating its effectiveness in this population is still lacking. Additional large and well-designed randomized controlled trials are needed to clarify definitive indications for ICSI in non-male factor infertility.
Source: Journal of Assisted Reproduction and Genetics - Category: Reproduction Medicine Source Type: research
Abstract The human zona pellucida (ZP) is a highly organized glycoprotein matrix that encircles oocytes and plays an essential role in successful reproduction. Previous studies have reported that mutations in human ZP1, ZP2 and ZP3 influence their functions and result in a lack of ZP or in an abnormal oocytes and empty follicle syndrome, which leads to female infertility. Here, we performed whole-exome sequencing in two probands with primary infertility whose oocytes lacked a ZP, and we identified a heterozygous mutation in ZP1 (NM_207341:c.326G>A p.Arg109His), which is situated in the N-terminus, and a heteroz...
Source: J Cell Mol Med - Category: Molecular Biology Authors: Tags: J Cell Mol Med Source Type: research
DiscussionCurrently, no multicenter, double-blind, randomized, placebo-controlled trials have been performed on the use of the DKP formula to improve on the clinical outcome of the conception of IVF-ET in women with low prognosis. DKP might provide a good clinical solution for females with low prognosis and undergoing IVF. There is no contemporary Western medicine to improve on the clinical outcome of conception in IVF-ET in women with low prognosis. Therefore, it is important to undertake a well-designed randomized trial to determine the effect of DKP in improving the clinical outcome of the conception of IVF-ET in women ...
Source: Trials - Category: Research Source Type: clinical trials
AbstractKey content Male infertility underlies or contributes to up to 50% of infertility cases; current therapeutic interventions rely on assisted reproductive technology (ART), as medical or surgical treatments have limited value in enhancing semen quality or parameters. Lifestyle factors that affect male fertility could offer a therapeutic opportunity; however, their modification seems to be of variable benefit. In the quest for sperm functional assessment and selection tests, there is controversy over which patients, if any, should be tested for  sperm DNA fragmentation, as well as which test to perform. Sperm...
Source: The Obstetrician and Gynaecologist - Category: OBGYN Authors: Tags: REVIEW Source Type: research
lmann F Abstract Infertility is defined as the inability of a couple to succeed in achieving a spontaneous pregnancy after 1 year. Male and female factors contribute to infertility with approximately 40% each. In the remaining cases factors that affect fertility can be found in both partners. The andrological work-up should be started simultaneously with the gynecological diagnostic procedure in order to identify and treat andrological factors related to infertility. Since the majority of intracytoplasmic sperm injection procedures are performed due to andrological infertility, andrological diagnostics c...
Source: Der Urologe. Ausg. A - Category: Urology & Nephrology Authors: Tags: Urologe A Source Type: research
AbstractKey content Male infertility underlies or contributes to up to 50% of infertility cases; current therapeutic interventions rely on assisted reproductive technology (ART), as medical or surgical treatments have limited value in enhancing semen quality or parameters. Lifestyle factors that affect male fertility could offer a therapeutic opportunity; however, their modification seems to be of variable benefit. In the quest for sperm functional assessment and selection tests, there is controversy over which patients, if any, should be tested for  sperm DNA fragmentation, as well as which test to perform. Sperm...
Source: The Obstetrician and Gynaecologist - Category: OBGYN Authors: Tags: REVIEW Source Type: research
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