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

Babigumira, Joseph B.; Sharara, Fady I.; Garrison, Louis P.

doi:10.1007/s10815-017-1021-4

Cited by 7 publications

(7 citation statements)

References 30 publications

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“…Our data suggest that Cap‐Score results could be used by clinicians to inform their patients of that man's ability to generate pregnancy and help guide a treatment pathway. The impact provided by such an approach was previously modeled and shown to not only increase clinical pregnancy rates but also to greatly reduce medical costs, in an age‐dependent fashion (Babigumira, Sharara, & Garrison, ).…”

Section: Discussionmentioning

confidence: 99%

Cap‐Score™ prospectively predicts probability of pregnancy

Schinfeld

Sharara

Morris³

et al. 2018

Molecular Reproduction Devel

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Semen analysis (SA) poorly predicts male fertility, because it does not assess sperm fertilizing ability. The percentage of capacitated sperm determined by GM1 localization (“Cap‐Score™”), differs between cohorts of fertile and potentially infertile men, and retrospectively, between men conceiving or failing to conceive by intrauterine insemination (IUI). Here, we prospectively tested whether Cap‐Score can predict male fertility with the outcome being clinical pregnancy within ≤3 IUI cycles. Cap‐Score and SA were performed (n = 208) with outcomes initially available for 91 men. Men were predicted to have either low (n = 47) or high (n = 44) chance of generating pregnancy using previously‐defined Cap‐Score reference ranges. Absolute and cumulative pregnancy rates were reduced in men predicted to have low pregnancy rates versus high ([absolute: 10.6% vs. 29.5%; p = 0.04]; [cumulative: 4.3% vs. 18.2%, 9.9% vs. 29.1%, and 14.0% vs. 32.8% for cycles 1–3; n = 91, 64, and 41; p = 0.02]). Only Cap‐Score, not male/female age or SA results, differed significantly between outcome groups. Logistic regression evaluated Cap‐Score and SA results relative to the probability of generating pregnancy (PGP) for men who were successful in, or completed, three IUI cycles (n = 57). Cap‐Score was significantly related to PGP (p = 0.01). The model fit was then tested with 67 additional patients (n = 124; five clinics); the equation changed minimally, but fit improved (p < 0.001; margin of error: 4%). The Akaike Information Criterion found the best model used Cap‐Score as the only predictor. These data show that Cap‐Score provides a practical, predictive assessment of male fertility, with applications in assisted reproduction and treatment of male infertility.

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Section: Discussionmentioning

confidence: 99%

Cap‐Score™ prospectively predicts probability of pregnancy

Schinfeld

Sharara

Morris³

et al. 2018

Molecular Reproduction Devel

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“…Knowledge of inherent fertilizing ability, such as obtained by the Cap‐Score™ performed in conjunction with semen analysis, and the timing of capacitation such as obtained by Cap‐Rate™, might enable clinicians to personalize infertility treatments for couples. The impact of a test able to provide this information has recently been modeled and shown to not only increase clinical pregnancy rate but also to reduce mean medical costs by $4,000 in couples with women under 35 years of age and by $19,200 in couples with women over 42 years of age (Babigumira, Sharara, & Garrison, ).…”

Section: Discussionmentioning

confidence: 99%

“…It is known that a significant proportion of couples fail this treatment repeatedly and are eventually directed to IVF/ICSI (Guzick et al, 2001;Ombelet et al, 1997;van der Steeg et al, 2011). (Babigumira, Sharara, & Garrison, 2018).…”

Section: Discussionmentioning

confidence: 99%

Timing of sperm capacitation varies reproducibly among men

Ostermeier¹,

Cardona²,

Moody³

et al. 2018

Molecular Reproduction Devel

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Sperm must mature functionally in the process of capacitation to become able to fertilize. Capacitation depends on membrane lipid changes, and can be quantitatively assessed by redistribution of the ganglioside GM1, the basis of the Cap‐Score™ sperm function test. Here, differences in Cap‐Score were compared among and within men at two time points. Ejaculates were liquefied, washed, and incubated for 3 hr under capacitating (Cap) conditions, then fixed and analyzed immediately (Day0); after being incubated 3 hr under Cap conditions then maintained 22–24 hr in fix (Day1‐fix); or after 22–24 hr incubation under Cap conditions prior to fixation (Day1). In all cases, a light fixative previously shown to allow membrane lipid movements was used. Day1‐fix and Day1 Cap‐Scores were greater than Day0 (p < 0.001; n = 25), whereas Day1‐fix and Day1 Cap‐Scores were equivalent (p = 0.43; n = 25). In 123 samples from 52 fertile men, Cap‐Score increased more than 1SD (7.7; calculated previously from a fertile cohort) from Day0 to Day1‐fix in 44% (54/123) of the samples. To test whether timing of capacitation was consistent within an individual, 52 samples from 11 fertile men were classified into either “early” or “late” capacitation groups. The average capacitation group concordance within a donor was 81%. Median absolute deviation (MAD; in Cap‐Score units) was used to assess the tightness of clustering of the difference from Day0 to Day1‐fix within individuals. The average (2.21) and median (1.98) MAD confirmed consistency within individuals. Together, these data show that the timing of capacitation differed among men and was consistent within men.

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“…SA results guide clinical decisions, with semen parameter values often determining treatment trajectories that have very different physical, emotional, and financial costs. For example, the standard of care (SOC) derived cost disparities between procedures such intrauterine insemination (IUI, cost range: $1,275–$3,825) and in vitro fertilization with intracytoplasmic sperm injection (IVF/ICSI, cost range: $8,825–$26,476) are significant [ 23 ]. The SOC assumes three cycles of both IUI and IVF/ICSI [ 23 ].…”

Section: Problems Of Basing Clinical Decisions On Manual Semen Analysmentioning

confidence: 99%

“…For example, the standard of care (SOC) derived cost disparities between procedures such intrauterine insemination (IUI, cost range: $1,275–$3,825) and in vitro fertilization with intracytoplasmic sperm injection (IVF/ICSI, cost range: $8,825–$26,476) are significant [ 23 ]. The SOC assumes three cycles of both IUI and IVF/ICSI [ 23 ]. The decision about which technique to use is often based on total motile sperm count (TMSC) [ 24 25 26 ].…”

Section: Problems Of Basing Clinical Decisions On Manual Semen Analysmentioning

confidence: 99%

A Novel Approach to Improving the Reliability of Manual Semen Analysis: A Paradigm Shift in the Workup of Infertile Men

Douglas

Parekh

Kahn

et al. 2021

World J Mens Health

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Conventional semen analysis (SA) is an essential component of the male infertility workup, but requires laboratories to rigorously train and monitor technicians as well as regularly perform quality assurance assessments. Without such measures there is room for error and, consequently, unreliable results. Furthermore, clinicians often rely heavily on SA results when making diagnostic and treatment decisions, however conventional SA is only a surrogate marker of male fecundity and does not guarantee fertility. Considering these challenges, the last several decades have seen the development of many advances in SA methodology, including tests for sperm DNA fragmentation, acrosome reaction, and capacitation. While these new diagnostic tests have improved the scope of information available to clinicians, they are expensive, time-consuming, and require specialized training. The latest advance in laboratory diagnostics is the measurement of seminal oxidation-reduction potential (ORP). The measurement of ORP in an easy, reproducible manner using a new tool called the Male Infertility Oxidative Stress System (MiOXSYS) has demonstrated ORP's potential as a feasible adjunct test to conventional SA. Additionally, the measurement of ORP by this device has been shown to be predictive of both poor semen quality and male infertility. Assessing ORP is a novel approach to both validating manual SA results and identifying patients who may benefit from treatment of male oxidative stress infertility.

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

Cited by 7 publications

References 30 publications

Cap‐Score™ prospectively predicts probability of pregnancy

Cap‐Score™ prospectively predicts probability of pregnancy

Timing of sperm capacitation varies reproducibly among men

A Novel Approach to Improving the Reliability of Manual Semen Analysis: A Paradigm Shift in the Workup of Infertile Men

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