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SPERM DNA INTEGRITY TEST^SM (SDI)

• Introduction
• Indication for Testing
• Detection Method
• Interpretation of Results from Milenova's SPERM DNA INTEGRITY TEST^SM (SDI)
• Specimen Collection and Shipping Requirements
• Turn around Time
• Cost
• Request Hard Copy
• References

Introduction
Results of recent research indicate that sperm quality influences not only rates of fertilization of eggs, but also subsequent embryo development. In humans, these paternal effects have been shown to affect rates of embryo cleavage, blastocyst formation and implantation. The markers of sperm quality used to predict pregnancy outcome are not the parameters included in the standard semen analysis (sperm concentration, motility or morphology), but rather the results of the Millenova's SPERM DNA INTEGRITY TEST^SM (SDI). Millenova's SPERM DNA INTEGRITY TEST^SM (SDI) measures DNA damage in sperm and is reported as DNA fragmentation index (DFI) and high DNA staining (HDS). The mechanism by which damaged sperm DNA affects pregnancy outcome is not known.

Indication for Testing
Male partners of couples with a history of unexplained infertility, poor embryo quality after in vitro fertilization (IVF), implantation failure after IVF, recurrent chemical or occult pregnancy losses, or recurrent early spontaneous abortions should be tested with Millenova's SPERM DNA INTEGRITY TEST^SM (SDI).

Detection Method
Millenova's SPERM DNA INTEGRITY TEST^SM (SDI) is based on utilization of metachromatic features of Acridine Orange (AO), a DNA -probe, and the principles of flow cytometry. The assay measures the susceptibility of DNA to denaturation in situ after low pH treatment what denatures protamine associated DNA in sperm cells but does not denature DNA associated with histones. Spermatozoa with normal chromatin structure do not demonstrate DNA denaturation. AO that intercalates into dsDNA (normal) fluoresces green, while AO that associates with ssDNA (denatured) fluoresces red when excited by 488nm light source.

Interpretation of Results from Millenova's SPERM DNA INTEGRITY TEST^SM (SDI)
Damaged DNA in the single sperm cell that fertilizes a female oocyte can have a dramatic negative impact on fetal development and health of the offspring. The control group studies with current protocol revealed that the thresholds of sperm DFI of 0-15%, 16-29%, and =30% relate to high, good to fair, and low to poor fertility potential, respectively. Limited data show that if semen samples contain =30% sperm with denatured DNA, few pregnancies occurred when fertilized by IVF or ICSI technique.

Specimen Collection and Shipping Requirements
A semen sample should be collected by masturbation and allowed to liquefy at room temperature for approximately 30 minutes. The semen specimen should be transferred to nunc tubes labeled with the patient's name and date. The labeled nunc tube is the placed directly into liquid nitrogen (or -70oC freezer). Semen can be kept for up to 5 hours at room temperature prior to freezing without loss of quality. Only FedEx (or other overnight carrier) must ship semen samples in liquid nitrogen in high quality, insulated, commercial shipping containers with liquid nitrogen (or dry ice). Millenova Immunology Laboratories will provide the shipping containers - call for details. Shipments should be sent only Monday through Wednesday.

Turn around Time
Processing of specimens begins immediately upon receipt at our facilities. Results are routinely available within 7-10 days and are initially faxed, then mailed to the requesting physician.

Cost
Included in our fees are specimen collection and shipping materials, all courier and shipping charges, telephone and written reports, and consultation with physicians. Please call 1-877-737-7652 for pricing information.

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2. Hammadeh ME, Al-Hassani S, Stieber M et al. The effect of chromatin condensation (aniline blue staining) and morphology (strict criteria) of human sperm on fertilization, cleavage and pregnancy rates in an intracytoplasmic sperm injection programme. Hum Reprod 1996;11:2468-2471.
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4. Larson K, De Jonge C, Barnes A, Jost L, Evenson D. Relationship between assisted reproductive techniques (ART) outcome and status of chromatin integrity as measured by the sperm chromatin structure assay. Hum Reprod 2000;15:1717-1722.
5. Evenson DP, Larson KL, Jost LK. Relationship between assisted reproductive techniques (ART) outcome and status of chromatin integrity as measured by the sperm chromatin structure assay. Hum Reprod 2000;15:1717-1722.
6. Evenson DP, Larson KL, Jost LK. Sperm chromatin structure assay: its clinical use for detecting sperm DNA fragmentation in male infertility and comparisons with other techniques. J Androl 2002;23:25-42.
7. Evenson D, Jost L. Sperm chromatin structure assay is useful for fertility assessment. Meth Cell Sci 2000; 22:169-189.