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...
Condition: Infertility Interventions: Drug: prednisolone; Drug: Acetyl Salicylic acid Sponsor: Kasr El Aini Hospital Not yet recruiting
Conclusion Subfertile women with a WHO II ovulation disorder have a good prognosis on live birth, and most did so after ovulation induction with clomiphene-citrate. If first-line ovulation induction has failed ovulation induction with gonadotrophins or IVF still result in a live birth in about half of the cases.
500,000 men in the US undergo vasectomy annually. About 6% will change their mind. 2 options to conceive are vasectomy reversal (VR) or sperm retrieval (SR) with in vitro fertilization/intracytoplasmic sperm injection (IVF/ICSI). Often the male partner is only evaluated by a urologist and counseled and treated with a VR without an evaluation or counseling of the female, or the female is evaluated by a reproductive endocrinologist (RE) on the option of IVF/ICSI, and the male partner is referred to a urologist to perform SR for use with IVF/ICSI.
We examined the effect of microsurgical subinguinal varicocele repair (VR) on sperm DFI assessed by terminal deoxynucleotidyl transferase dUTP nick end labeling (TUNEL) assay and/or sperm chromatin structure assay (SCSA) and correlated these data with pregnancy and live birth outcomes at IVF/ICSI.
Microdissection testicular sperm extraction (micro TESE) is the major surgical procedure of sperm retrieval for patients with non-obstructive azoospermia (NOA) in artificial reproductive technique (ART) with intracytoplasmic sperm injection (ICSI). At micro TESE, seminiferous tubules with larger diameter (>300 μm) are searched and picked under the operative microscope, and the tissue is sent for sperm retrieval by the embryologist. When the sperm is confirmed retrieved, and the procedure of micro TESE can then be finished.
For over a decade, no studies have compared fertility outcomes between vasectomy reversal (VR) and in vitro fertilization (IVF) with intracytoplasmic sperm injection for older couples seeking a biologic child. We sought to provide pregnancy rates from a contemporary series of VR in men with female partners 35 years and older, and to correlate the results with pregnancy rates via IVF for women 35 years and older.
Sperm deoxyribonucleic acid (DNA) fragmentation has been associated with male infertility and studies suggest that sperm DNA fragmentation can have an adverse influence on pregnancy outcomes with assisted reproduction. The aim of the present study was to examine the intracytoplasmic sperm injection (ICSI) pregnancy outcomes using testicular sperm in couples that have failed ICSI cycles using ejaculate sperm.
Sperm DNA fragmentation is a biomarker of male infertility and results in poorer IVF outcomes. The Comet assay measures the DNA damage in individual sperm enabling the degree of heterogeneity of the whole sperm population to be assessed. The aim of this study was to explore the impact of this heterogeneity, assess the diagnostic and predictive power of novel Comet parameters that quantify different damage levels in the semen sample. We also determined if quantifying the proportion of sperm with low or high DNA damage increases the predictive value of Comet test for the diagnosis of male infertility and prediction of ART live birth rates.
Condition: Infertility Intervention: Other: ICSI Sponsor: Reproductive Medicine Associates of New Jersey Recruiting