Physicians

Androvia LifeSciences Presented Data, Providing Scientific Insights that Support Clinical Utility of Cap-Score™, a Validated and Consistent Measure of Fertility

Research presented at 47th Annual Conference of the American Society of Andrology (ASA) demonstrates ability of Cap-Score Test to measure and predict a man’s fertility

La Jolla, CA., May 16, 2022 – Androvia LifeSciences announced today that it presented multiple abstracts at the 47^th Annual Conference of the American Society of Andrology (ASA). Collectively, the information presented in the abstracts demonstrated the clinical utility of the Cap-Score™ Test in quantifying the man’s fertility. A laboratory developed test, the Cap-Score Test is the only test that indicates the percentage of sperm that can actually fertilize an egg, providing men (and couples) with their probability of a generating a pregnancy (PGP).

In the poster sessions, Dr. Alexander Travis, Director of the Master of Public Health Program, Chair of the Department of Public and Ecosystem Health, and Professor, Cornell University, and Chief Scientific Officer, Androvia LifeSciences, presented three abstracts:

1. Expanding access to male fertility testing through validation of an at home collection kit
2. Modifying capacitation ability through lifestyle changes
3. In men seeking fertility assistance, defects in sperm capacitation/fertilizing ability are common in all age groups, in contrast, semen volume and motility declined with age

A validation study, Expanding access to male fertility testing through validation of an at home collection kit, generated real-world data demonstrating the consistency of Cap-Score between home collection versus processing at clinics. In practice, the use of a home collection kit allows clinics to focus on other responsibilities, encourages men to pursue fertility workups from the privacy of their own home and thereby increases the availability of fertility evaluations.

Modifying capacitation ability through lifestyle changes, yielded data that further supports the view that promoting a man’s overall health by introducing positive lifestyle changes, in conjunction with nutritional supplements, is linked to changes in sperm capacitation and an increase in male fertility. The study concluded that although promoting a man’s overall health had little impact on traditional semen analysis measures, improvement in sperm capacitation ability was observed as well as positive increases in a man’s PGP.

In men seeking fertility assistance, defects in sperm capacitation/fertilizing ability are common in all age groups, in contrast semen volume and motility declined with age, established that reductions in capacitation, or sperm fertilizing ability, were equally present across age groups in men questioning their fertility (MQF). These data show that impaired ability to fertilize is not restricted to older men, but is equally prevalent in young men suffering from problems with their fertility, even though young men are more likely to pass traditional semen analysis. Confirming multiple earlier studies, the ability of sperm to fertilize was reduced in MQF when compared to men with known paternity.

An overview of the poster presentations at ASA can be found here: https://andrologysociety.org/2022-annual-meeting/#agenda.

Androvia LifeSciences is a NY-based, privately held company focused on developing new diagnostics that provide a higher level of patient management of male fertility for use by clinicians to counsel couples. The company’s objective is to understand male fertility at its most fundamental level – what enables a sperm to fertilize an egg, how a man’s fertility can be measured, and how together, this knowledge can be applied to improve a man’s fertility and clinical pregnancy outcomes. Cap-Score helps clinicians more accurately identify the role male infertility plays in a couple’s journey toward pregnancy. It thereby helps identify where the infertility lies, allowing the clinician to personalize treatment options from the start and dramatically increase success, reduce costs and shorten the pathway to parenthood.

The company operates at the highest standard of laboratories which is CLIA compliant, New Jersey DOH approved, accredited by the College of American Pathology and licensed by New York State as both a facility and as an approved Laboratory Test. The company has analyzed over 6000 patient samples since late 2016, has published seven peer reviewed articles and has made multiple invited presentations on its cutting-edge technology. The Cap-Score Test is available as a Home Collection Kit, and is currently available to physicians and couples throughout the United States. Androvia LifeSciences also has exclusive global rights to the Cap-Score technology. Please visit www.androvialife.com to learn more or to request access to the Cap-Score Test at your clinic.

PUBLISHED STUDY SHOWS PREDICTIVE POWER OF CAP-SCORE

In a recently published prospective study in the journal, Molecular Reproduction and Development, men who exhibited a normal Cap-Score had more than a fourfold increase in generating a pregnancy during the first attempt, compared to those men who scored low. Similarly, men who had a normal score, also had a dramatic and consistently higher ability to generate a pregnancy in both the second and third attempts.*

In this study, Cap-Score and clinical pregnancy outcomes were analyzed for 91 couples. Based on their Cap-Scores, men were separated into groups that categorized them by their probability to generate a pregnancy. The published data showed that men with normal Cap-Scores generated four times the number of pregnancies in the first attempt than men with low Cap-Scores.*

Next, the study tested the ability of the traditional semen analysis to measure a man’s fertility and predict his probability of generating a pregnancy, versus Cap-Score. This was done by comparing the semen analysis measures — sperm count, motility, volume — of men who were and were not successful in generating a pregnancy. Of all sperm measures, Cap-Score alone was deemed the most appropriate measure and predictor of a man’s ability to generate a pregnancy. Simply stated, Cap-Score is the only proven measure of a man’s fertility.

The potential increase in clinical pregnancy rates and cost savings attributable to Cap-Score, consistently improve with age. The Cap-Score therefore increases in clinical and economic value for couples who would otherwise have a hard time conceiving.

VALUE OF CAP-SCORE TO ALL COUPLES

The Cap-Score, whether normal or low, allows the clinician along with the couple, to determine what degree of fertility assistance or intervention may be needed. If you are actively trying to conceive or just thinking about starting a family, knowledge of his Cap-Score can highlight where potential issues may lie, be it the man or the woman. Cap-Score can serve as the initial guide to what steps you should take first as a couple and how soon you should take them.

Even with a low Cap-Score, conception is still possible. As with any Cap-Score result, including a normal score, it is always advantageous to speak with a reproductive specialist. Fertility is never a finite measure. It’s dynamic and can be influenced by any number of male or female factors. As such, fertility exists in a low to high spectrum. Depending on the man’s probability to generate a pregnancy, along with any other contributing factors of the couple, a reproductive specialist may suggest different degrees of intervention, or none at all.

Male fertility exists in a low to high continuum, rather than a binary “fertile vs infertile” categorization defined by a specific cut-off.

“The ability to determine the man’s probability of generating a pregnancy is a substantial advance for all couples when planning their families. This is particularly important when childbirth is being delayed resulting in an increased likelihood of encountering potential problems,” said Gianpiero Palermo, MD, PhD, Director of Assisted Fertilization and the Andrology Laboratory at the Ronald O. Perelman and Claudia Cohen Center for Reproductive Medicine.

Cap-Score is also a powerful tool when it comes to understanding and managing the man’s fertility. Cap-Score can help assess substances that may be beneficial or harmful to a man’s reproductive system. Cap-Score provides a way to track effects on the man’s fertility, and more importantly, identify whether these effects are positive or negative. Everyday medications we take may have a negative impact on fertility. Conversely, there are supplements and suggested lifestyle changes purported to improve a man’s fertility. Cap-Score offers a way to measure the man’s fertility by providing a mechanism to closely track the effects of a suggested regimen or lifestyle change, and whether it increases, decreases or maintains your current level of fertility.

Multicentric, prospective observational data show sperm capacitation predicts male fertility, and cohort comparison reveals a high prevalence of impaired capacitation in men questioning their fertility

April 30, 2020
Fady Sharara, Eric Seaman, Randy Morris, Jay Schinfeld, Jennifer Nichols, Michael Sobel, Annette Lee, Stephen Somkuti, Steven Hirshberg, Tara Budinetz, Larry Barmat, Gianpiero Palermo, Zev Rosenwaks, Natan Bar-Chama, Joshua Bodie, John Nichols, John Payne, Travis McCoy, Edward Tarnawa, Gail Whitman-Elia, Lauren Weissmann, Maria Doukakis, Joshua Hurwitz, Mark Leondires, Cynthia Murdock, Ilana Ressler, Spencer Richlin, Shaun Williams, Matthew Wosnitzer, Michael Butcher, James Kashanian, Peter Ahlering, Mira Aubuchon, G. Charles Ostermeier, Alexander J. Travis
RBMO.2020; 1-11

Cap-Score™ prospectively predicts probability of pregnancy

September 25, 2018
Jay Schinfeld, Fady Sharara, Randy Morris, Gianpiero D. Palermo, Zev Rosenwaks, Eric Seaman, Steve Hirshberg, John Cook, Cristina Cardona, G. Charles Ostermeier, Alexander J. Travis.
Mol. Reprod Dev. 2018; 1-11.

Timing of sperm capacitation varies reproducibly among men

April 2, 2018
G. Charles Ostermeier, Cristina Cardona, Melissa A. Moody, Alana J. Simpson, Romeo Mendoza, Eric Seaman, Alexander J. Travis
Mol. Reprod Dev. 2018; 1-10.

Projecting the potential impact of the Cap-Score™ on clinical pregnancy, live births, and medical costs in couples with unexplained infertility

September 23, 2017
Babigumira, J.B., Sharara, F.I. & Garrison, L.P.
J Assist Reprod Genet (2018) 35:99-106

Localization patterns of the ganglioside GM1 in human sperm are indicative of male fertility and independent of traditional semen measures

April 18, 2017
Cardona C, Neri Q, Simpson A, Moody M, Ostermeier GC, Seaman E, Paniza T, Rosenwaks Z, Palermo G, Travis A
Mol. Reprod Dev. 2017; 84:423-435

Validation of a laboratory-developed test of human sperm capacitation

April 18, 2017
Moody M, Cardona C, Simpson A, Moody M, Smith T, Travis A, Ostermeier GC
Mol. Reprod Dev. 2017; 84:408-422

What do semen parameters mean? How to define a normal semen analysis

July 15, 2015
Chiles KA, Schlegel PN.
Andrology (Los Angel), 2015, 4: 136. 0:0, (2015)

Infertility counseling (or the lack thereof) of the forgotten male partner

June 3, 2015
Petok, William D.
Fertility and Sterility , Volume 104 , Issue 2 , 260 – 266

Limitations of semen analysis as a test of male fertility and anticipated needs from newer tests

November 25, 2014
Wang, Christina et al.
Fertility and Sterility , Volume 102 , Issue 6 , 1502 – 1507

Sperm functional tests

October 24, 2014
Oehninger, Sergio et al.
Fertility and Sterility , Volume 102 , Issue 6 , 1528 – 1533

Lipid modulation of calcium flux through CaV2.3 regulates acrosome exocytosis and fertilization

February 10, 2014
Cohen, Roy et al.
Developmental Cell , Volume 28 , Issue 3 , 310 – 321

Semen analysis and sperm function testing

December 19, 2011
Franken DR, Oehninger S.
Asian Journal of Andrology. 2012 Jan; 14(1): 6-13

Data presented at past scientific meetings: