Semen analysis

Abstract

Provided is a method for measuring the total sperm concentration (TSC) in a sample including: (i) placing the sample in a transparent container between a synchronically pulsed light source and a photodetector; and (ii) measuring the optical absorbance of the sample in the range of 800-1000 nm, the TSC of the sample being proportional to the absorbance. Further provided is a sampling device for use in optically analyzing a biological fluid, a method for measuring motile sperm concentration (MSC) in a semen sample, a method of determining the average velocity (AV) of sperm cells and a system for analyzing semen quality comprising means for measuring TSC, means for measuring MSC; and a video visualization system.

Description

FIELD OF THE INVENTION[0001]This invention relates to semen analysis.BACKGROUND OF THE INVENTION[0002]According to WHO statistics, 8-10% of all married couples consult medical professionals after failing to conceive. Over 40 million couples are currently being treated for infertility. Among these infertile couples, it is estimated that the infertility in 40% of the couples is due to male originating causes, and another 20% is due to combined male and female originating causes. Semen analysis is a major technique in evaluating male originating causes.[0003]Standard semen analysis protocol involves the determination of at least three major semen parameters:[0004]1. total sperm concentration (TSC);[0005]2. percentage of motile sperm; and[0006]3. percentage of normal sperm morphologies.[0007]For all practical purposes, semen analysis, a key factor in human male fertility medicine, has not changed since the 1930's and is still done today by microscopic inspection. In fact, it is one of t...

AI Technical Summary

Benefits of technology

[0039]In a preferred embodiment, the biological fluid is semen, most preferably human semen. The device serves both as a sampler and dual test chamber, enabling simultaneous testing of TSC and MSC. No dilution is required for any of the measurements. This not only saves labor but also eliminates a significant source of errors—namely, dilution inaccuracy.

[0055]It should be noted that most semen analysis protocols require data on the % of sperm having progressive motility rather than their average velocity. Progressive motility is defined as those sperm having an average velocity of 5 microns / second or more. This parameter too, can readily be extracted from the average velocity if a normal spread of velocities is assumed around the average. Even in cases where the velocity spread is not normal, the error in calculating the % of progressively motile sperm is not significantly affected. Moreover, when different minimal velocities are defined as progressively motile, this varying threshold is readily entered into the calculation, thereby giving extra flexibility in providing this parameter. This is important when working in different diluting media, ambient temperatures or in fact different species in vet measurements.

[0068]The video visualization system enables “freezing” a given selected view (or a few views) which may then be printed and attached to the Semen Analysis Report. This is of great value for consultations and validation of treatment efficacy. A by-product of the freezing option is viewing the semen sample under static conditions. This strongly facilitates analysis and counting. In microscopic assessments, this can only be done by demobilizing (killing) the sperm prior to viewing. Even then, all dead sperm will end up in one layer, a condition which normally complicates analysis due to high concentration and sperm overlap in the said layer.

Problems solved by technology

This work requires high expertise, is very labor intensive and if done according to standard protocols, takes at least an hour per test.

Manual assessments are known to be quite inaccurate due to numerous sources of error.

The large statistical errors due to the limited number of sperm analyzed.

This itself is an error introducing procedure due to the tediousness and time consuming nature of the task.

As a result of the above methodology, semen analysis test results are globally recognized to be highly subjective, inaccurate and poorly reproducible.

Although these systems have attempted to replace manual analysis and establish industry accepted standards, they have not succeeded in either of these objectives.

The first objective could not be achieved because analysis results continue to be dependent on manual settings and on the different makes of equipment.

Replacing routine manual analysis is totally impracticable because the systems are extremely expensive, complex and difficult to use.

The SMI parameter, although useful in some applications, was not significantly accepted by the medical community as a viable alternative to the conventional microscopic semen measurements.

(1) Human sperm concentrations in the normal range (and even in higher than normal cases), are more than an order of magnitude lower than in most of their veterinary counterparts—where this technology has been adopted.

(2) Human cases are treated even when sperm concentrations are far below their normal levels. This of course is not the case for animals. Infertile animals are normally culled—in any case, they are not treated for infertility.

(3) TSC in humans is a parameter, which in itself, is totally insufficient for fertility investigations, and microscopic analysis is in any case required for all the other data in the standard semen analysis protocol. To a large degree, this also holds for veterinary applications. This fact made optical absorption measurements superfluous, and no real effort has been invested in this field.

These factors (high expertise and sophisticated environment) along with the prohibitive cost of such instrumentation, rule out for all practical purposes their application for routine semen analysis.

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