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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In this study, our aim was to determine which factor is more correlated with the number of oocytes retrieved in patients with endometrioma compared with controls undergoing in vitro fertilisation-intracytoplasmic sperm injection (IVF-ICSI) cycles: antral follicle count (AFC) or anti-Müllerian hormone (AMH). A total of 60 women with endometrioma and a control population of 60 women without endometrioma in the same period were randomly selected underwent the injection IVF-ICSI treatment. No significant differences were found between the groups in terms of age (28.78 ± 3.49 vs. 29.52 ±&...
Source: Journal of Obstetrics and Gynaecology - Category: OBGYN Tags: J Obstet Gynaecol Source Type: research
Authors: Ozgur K, Bulut H, Berkkanoglu M, Humaidan P, Coetzee K Abstract The present study was performed to investigate whether maternal body mass index (BMI) affected the live birth (LB) outcomes of frozen embryo transfers (FET) in patients who underwent freeze-all treatment cycles. The autologous intracytoplasmic sperm injection (ICSI) cycles with blastocyst freeze-all cycles performed between February 2015 and January 2016 were retrospectively investigated. The 1188 subsequent FET performed were grouped according to maternal BMI classes for analysis; underweight (
Source: Journal of Obstetrics and Gynaecology - Category: OBGYN Tags: J Obstet Gynaecol Source Type: research
This study therefore aimed to assess sperm telomere length in addition to DNA damage, lipid peroxidation and protamine deficiency in infertile men with previously failed/low fertilization post-ICSI.DesignSemen samples were obtained from infertile men with previous failed/low fertilization rates (n = 10). Chromatin integrity (chromomycin A3 staining and TUNEL assay), lipid peroxidation (BODIPY probe) and telomere length (real-time PCR) for semen samples from these men were compared with samples obtained from fertile individuals (n= 10).ResultsThe results showed significantly higher mean values for sperm DNA damage,...
Source: Reproductive BioMedicine Online - Category: Reproduction Medicine Source Type: research
AbstractBackgroundThe use of testicular over ejaculated spermatozoa for ICSI has been presented as an alternative to overcome infertility in men with poor semen parameters or high levels of sperm DNA fragmentation.ObjectiveTo evaluate the efficacy of testicular ICSI outcomes in couples with no previous live birth and recurrent ICSI failure using ejaculated spermatozoa by comparison to the outcomes of couples with similar history of recurrent ICSI using ejaculated spermatozoa only.Materials and MethodsA total of 145 couples undergoing ejaculated or testicular ICSI cycles with no previous live births and with at least two pr...
Source: Andrology - Category: Urology & Nephrology Authors: Tags: Original Article Source Type: research
Condition:   Infertility Intervention:   Drug: Estradiol Valerate Sponsor:   Cairo University Recruiting
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
Condition:   Infertility Intervention:   Drug: Estradiol Valerate Sponsor:   Cairo University Recruiting
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
Condition:   Infertility Intervention:   Drug: Estradiol Valerate Sponsor:   Cairo University Recruiting
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
Condition:   Infertility Intervention:   Drug: Estradiol Valerate Sponsor:   Cairo University Recruiting
Source: ClinicalTrials.gov - Category: Research Source Type: clinical trials
We examined the association between infertility treatment and severe maternal morbidity in pregnancy and the postpartum period. METHODS: We conducted a cohort study using population-based registries from Ontario between 2006 and 2012. Pregnancies achieved using infertility treatment (ovulation induction, intrauterine insemination or in vitro fertilization with or without intracytoplasmic sperm injection) were compared with unassisted pregnancies using propensity score matching, based on demographic, reproductive and obstetric factors. The primary outcome was a validated composite of severe maternal morbidity or matern...
Source: cmaj - Category: General Medicine Authors: Tags: CMAJ Source Type: research
Publication date: 2–8 February 2019Source: The Lancet, Volume 393, Issue 10170Author(s): David Miller, Susan Pavitt, Vinay Sharma, Gordon Forbes, Richard Hooper, Siladitya Bhattacharya, Jackson Kirkman-Brown, Arri Coomarasamy, Sheena Lewis, Rachel Cutting, Daniel Brison, Allan Pacey, Robert West, Kate Brian, Darren Griffin, Yakoub KhalafSummaryBackgroundSperm selection strategies aimed at improving success rates of intracytoplasmic sperm injection (ICSI) include binding to hyaluronic acid (herein termed hyaluronan). Hyaluronan-selected sperm have reduced levels of DNA damage and aneuploidy. Use of hyaluronan-based sp...
Source: The Lancet - Category: General Medicine Source Type: research
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