Strict Criteria Sperm Morphology for Infertility Diagnosis and Treatment, Semen
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
Categorizing sperm according to strict criteria based on measurements of head and tail sizes and shapes. Sperm with abnormalities in head/tail size/shape are not capable of completing critical steps in sperm transport and fertilization. Therefore, the test is useful in diagnosing male infertility.
Selecting the most cost-effective therapy for treating male-factor infertility
Quantifying the number of germinal and WBCs per mL of semen. High numbers of germinal cells and WBCs are indicative of possible disorders in spermatogenesis and genital tract infection, respectively.
Kruger Criteria Strict Morphology
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Strict Criteria Sperm Morphology
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
Patient should have 2 to 7 days of sexual abstinence at the time of semen collection for accurate results.
Submit only 1 of the following specimens:
Semen specimen must arrive within 24 hours of collection. Send specimen Monday through Thursday only and not the day before a holiday. If holiday falls on a Saturday, holiday will be observed on the preceding Friday. Sunday holidays are observed on the following Monday. Specimen should be collected and packaged as close to shipping time as possible. Laboratory does not perform testing on weekends.
Specimen Type: Semen
Container/Tube: Semen Analysis Kit (Supply T178)
Specimen Volume: Total ejaculate
Additional Information: Specimen volume is required.
Specimen Type: Semen on slides
Specimen Volume: 2 slides-10 microL of liquefied semen on each slide
1. If sperm concentration is <10 million/mL, centrifuge the specimen at 300 x G for 10 minutes before making slides.
2. Label 2 frosted slides in pencil with the patient's first and last name and the date of specimen collection.
3. Allow the semen to liquefy for 30 minutes. Then place 10 microL of liquefied semen on the label end of each slide, and evenly smear the specimen using a plain slide (this process is the same as making a blood smear).
4. Allow the smears to air dry for 15 minutes before placing the slides into a slide holder for shipment.
Additional Information: Total sperm concentration is required.
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
A minimum count is needed. Lab will determine.
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Infertility affects 1 out of 6 couples of child-bearing age. Approximately 40% of infertility has a female-factor cause and 40% a male-factor cause. The remaining 20% of infertility is due to a combination of male- and female-factor disorders or is unexplained.
One of the more successful treatments for male and/or female infertility is in vitro fertilization (IVF). Male partners are tested with the strict criteria sperm morphology test prior to IVF to assist in the diagnosis of male-factor defects which are not evident from the standard semen analysis (SEMA/9206 Semen Analysis with WHO Morphology).
The World Health Organization morphology procedure used in conjunction with the standard semen analysis provides only a rapid, subjective estimate of sperm shape and size. Morphology testing does not permit diagnosis of all sperm function defects because sperm are not categorized according to strict criteria by measuring sperm dimensions with a micrometer, as is the case with strict criteria sperm morphology. Assay reproducibility (inter- and intra-assay technician variation) is greatly improved with strict criteria sperm morphology testing as compared with the quick assessment provided with a standard semen analysis.
Abnormalities in sperm morphology cause or are related to: defects in sperm transport, sperm capacitation, the acrosome reaction, binding/penetration of the zona pellucida, and/or fusion with the oocyte vitelline membrane. All of these steps are essential to normal fertility.
Strict criteria sperm morphology testing also greatly assists with selecting the most cost-effective in vitro sperm processing and insemination treatment for the couple's IVF cycle. Sperm with severe head abnormalities cannot bind to the zona pellucida. These patients require intracytoplasmic sperm injection in association with their IVF cycle to ensure optimal levels of fertilization are achieved. This, in turn, provides the patient with the best chance of pregnancy.
Reference Values Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.
> or =4.5%
<4.00 x 10(6) (normal)
> or =4.00 x 10(6) (indicative of a possible disorder in spermatogenesis)
<1.00 x 10(6) (normal)
> or =1.00 x 10(6) (indicative of a possible genital tract infection)
-<4.00 x 10(6)/mL semen: normal
-> or =4.00 x 10(6)/mL semen: indicative of a possible disorder in spermatogenesis
-<1.00 x 10(6)/mL semen: normal
-> or =1.00 x 10(6)/mL semen: indicative of a possible genital tract infection
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
Conventional semen analysis (#81641 Semen Analysis) should be performed in conjunction with each strict criteria sperm morphology.
Clinical Reference Provides recommendations for further in-depth reading of a clinical nature
Kruger Morphology Conference, Boston, MA, October 9, 1993
Method Description Describes how the test is performed and provides a method-specific reference
Sperm is categorized according to strict criteria based on measurements of head and tail sizes and shapes. Sperm with abnormalities in head/tail size/shape are not capable of completing steps in the sperm transport and fertilization process. Quantification of the germinal and WBC content in semen is performed because the presence of germinal and WBCs are indicative of possible disorders in spermatogenesis and genital tract infection, respectively. The information collected will help to determine the most cost-effective therapy for treating male-factor infertility. (Wazzan W, Thomas A: Genital infection and male infertility. AFS Annual Meeting, Postgraduate course, 1990; Menkveld R, Oettle E, Kruger T, et al: Atlas of Human Sperm Morphology. Williams and Wilkins, Baltimore, MD, 1991)
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday through Friday; 3 p.m.
Send specimen Monday through Thursday only and not the day before a holiday.
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Slides are stored for at least 10 years
Performing Laboratory Location The location of the laboratory that performs the test
Test Classification Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.
This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. This test has not been cleared or approved by the U.S. Food and Drug Administration.
CPT Code Information Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
|Result ID||Reporting Name||LOINC Code|
|OVAL2||Strict Morph NL||In Process|
|ACRSM||Acrosom Defect||In Process|
|HDSAB||Head Shape Abnormal||10602-1|
|HDZAB||Head Size Abnormal||10602-1|
|MULTI||Multiple Defects||In Process|
|GERM3||Germ Cells/mL||In Process|