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MOUNTAINSIDE, N.J., April 4, 2016 /PRNewswire/ -- Androvia LifeSciences, focused on male fertility, today reported results of four new studies that use its proprietary technology to quantify the ability of sperm to fertilize. The Cap-ScoreTM Sperm Function Test offers a ranking where the fertilizing ability of a semen sample is compared to that from a population of fertile men and could potentially have implications for the management of human infertility.
"The results of these studies may assist health care professionals in their approach to treating male infertility, and may drive a personalized approach to helping couples conceive," said Alexander J. Travis, PhD, associate professor, Cornell University, who is an author on the studies being presented at the meeting.
Findings from all four studies presented at the 41st Annual Meeting of the American Society of Andrology in New Orleans, highlight the importance of the biological process of capacitation, through which sperm acquire the ability to fertilize an egg, and may explain how and why men who pass the traditional semen analysis often still have difficulty fertilizing. Without capacitation, fertilization cannot occur regardless of how many sperm are present, how they look, or their motility. Based on these new findings, couples in which men have normal Cap-Scores may be candidates for less invasive methods, such as an intrauterine insemination (IUI), whereas couples in which men have lower Cap-Scores may be recommended from the start to pursue approaches such as in-vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI), saving time and unnecessary stress for the couple.
At this meeting, Androvia will present Cap-Score ranges for a population of fertile men, and also present data showing that men seeking fertility work-ups have significantly lower Cap-Scores. In fact, while 83% and 97%, for concentration and motility respectively, of this group of 122 men passed the criteria for the traditional semen analysis parameters, only 59% were within or above one standard deviation from the mean for the population of fertile men. That is, a high percentage of men questioning their fertility have reductions in sperm function that can be identified through use of the Cap-Score. Such results demonstrate that many men questioning their fertility have defects in sperm function. This information can be used to personalize approaches to assisted reproduction, helping clinicians and couples choose the optimal approach that is best suited for them.
The study selected for an oral presentation at the meeting also demonstrates that the timing for sperm to reach peak fertility levels can differ significantly among men. These findings may impact how IUI, IVF and ICSI are conducted, as well as alter current recommendations related to timing natural conception. In this study, 38% of fertile men demonstrated significantly higher Cap-Scores after 24-hour exposure to stimuli for capacitation, while it was previously thought that sperm capacitation timing, from ejaculate to peak levels, is completed in less than 12 hours.
"More accurate testing is the first step towards more effective treatment. Looking forward, a new test for male infertility could potentially prove to be a game changer for physicians who treat infertility and for their patients. We are eagerly anticipating the release of this test in the hopefully near future," said Eric Seaman, MD, a veteran specialist in male fertility, and founder and director of the Center for Vasectomy, Vasectomy Reversal and Male Infertility of New Jersey. He is also an author on three of the presentations.
The third study presented by Androvia demonstrates that the Cap-Score Sperm Function Test does not strongly track with any of the parameters in a traditional semen analysis. This demonstrates that its insights into sperm function extend and complement the information provided by the most frequently used male fertility diagnostic.
Lastly, Androvia's fourth study documents the reliability of the test itself. For these studies, more than 100,000 different sperm cells were assessed to demonstrate that the Cap-Score Sperm Function Test is easily replicated both within and between technicians.
"The Cap-Score Sperm Function Test is the missing component in a comprehensive sperm analysis and fills an unmet need for medical professionals and couples trying to conceive," said Michael V. Novinski, chief executive officer, Androvia Life Sciences. "Cap-Score has the potential to bring fertility treatment to a new level as it offers a more fairly weighted assessment for the couple, moving treatment emphasis from the egg to the shared responsibility that it is."
In the US, 30% of all fertility cases are due to male factor alone and in other countries, that number can exceed 50%.
These new data significantly expand on earlier findings from studies performed by Gianpiero Palermo, MD, PhD, a world expert in the fertility field. Initially presented at the American Society of Reproductive Medicine 2014 annual meeting, these previous data showed a 55% pregnancy rate for men with acceptable Cap-Scores undergoing natural conception methods and IUI compared to a 6% pregnancy rate for men with low Cap-Scores attempting the same pregnancy methods.
About CapacitationCapacitation is the process sperm must undergo to become able to fertilize an egg. Currently, physicians do not have a practical way to evaluate the ability of sperm to capacitate. During capacitation, both the tail and head of the sperm undergo important transformations that depend on changes in membrane lipids, including removal of sterols and redistribution of the ganglioside GM1. These changes allow the sperm to start a hyperactivated swimming pattern and release enzymes, each of which contribute to the sperm's ability to move up the Fallopian tube and through the difficult-to-cross, jelly-like matrix of cells that surround the egg. Only a sperm that has capacitated is able to fertilize an egg.
About Cap-Score Sperm Function TestA laboratory developed test being designed to assess and measure the fertilizing ability of sperm, to help couples and reproductive health care professionals make informed decisions about the fertility solution that is best suited for that couple. The Cap-Score Sperm Function Test provides an analysis of the sperm on a molecular level, and is the only assay that evaluates capacitation, the process by which sperm acquire the ability to fertilize an egg. The test is being designed to complement the traditional semen analysis which determines sperm count, motility and appearance.
About Androvia LifeSciences Androvia LifeSciences is a biotechnology company focused on engineering scientific technology for the advancement of male fertility, and empowering couples with the information to help determine personalized fertility solutions.
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