Why Use SpermCheck Vasectomy in Your Practice?

SpermCheck Vasectomy provides benefits to both the physician and the patient. You eliminate the need to perform the tedious and time-consuming microscopic sperm counts for which you are not reimbursed. The patient benefits by eliminating the inconvenience and embarrassment of returning to your office or a laboratory to deliver a semen sample.

Market research indicates men would prefer to test their post-vasectomy sperm-concentration at home. The inconvenience and embarrassment associated with returning to the physician?s office or laboratory to supply semen samples has created an environment where approximately 33% of patients never return for their first follow-up sperm test and as many as 75% do not return for their second sperm test. When your patients use SpermCheck Vasectomy you will reduce your costs and increase your patients? compliance with post vasectomy semen analysis. Because the SpermCheck Vasectomy Kit contains two tests your patient is much more likely to be tested twice.

SpermCheck Vasectomy will also allow you and your patients to more effectively monitor for recanalization when you instruct your patients to test themselves at home with SpermCheck Vasectomy at an appropriate post-vasectomy interval of your choice.

SpermCheck Sensitivity and Procedure:

SpermCheck Vasectomy is calibrated to give a positive result when the sperm concentration is greater than 250,000/ml. This concentration corresponds to one sperm or fewer per standard high power microscopic field. Your patient is instructed to test himself twice at intervals determined by you. The patient is further instructed to test until he receives two consecutive negative results. By receiving two consecutive negative results you and your patient can be certain the patient’s vasectomy was successful, recanalization has not occurred, he is either azoospermic or severely oligospermic and his sperm count is in decline. The SpermCheck Vasectomy Kit includes a Response Card that the patient mails to you after recording his two results.

Rationale for the 250,000 Sperm/ml Decision Level for SpermCheck Vasectomy:

Studies of couples presenting with primary or secondary infertility show pregnancy rates of less than 1 per 100 person-years of unprotected intercourse when the sperm count was between 100,000 and 1 million/ml. Studies of candidate male hormonal contraceptives have shown that suppression of sperm production to severely oligospermic levels (less than 1 million/ml) provides high contraceptive efficacy. In one study, no pregnancies were seen in approximately 100 months of cumulative follow-up of men whose sperm counts were between 100,000 and 1 million/ml. A subsequent study of a depot progestin and androgen combination using a cut-off of 1 million/ml for entry into the efficacy phase reported no pregnancies in 426 person-months of treatment. Taken together, these data support the conclusion that sperm counts below 250,000/ml are associated with no significant risk of pregnancy. Finally, studies indicate that technical vasectomy failures and early recanalizations are characterized by sperm counts much higher than 250,000/ml.

Clinical Testing:

The performance of SpermCheck Vasectomy was compared to the WHO standard procedure of determining sperm concentration with a hemacytometer. A study used actual clinical samples from vasectomy patients at two clinics. A total of 144 post-vasectomy semen samples were analyzed. Samples were obtained at various intervals after surgery to insure an appropriate number of expected positive results. The results can be summarized as follows:

• When the SpermCheck Vasectomy result was negative the sperm concentration was below 300,000/ml 99% of the time and below 384,000/ml 100% of the time;

When the SpermCheck Vasectomy result was positive the sperm concentration was above 200,000/ml 99% of the time

Consumer Testing:

A consumer field evaluation of SpermCheck Vasectomy was conducted to determine the test performance when used by unassisted lay persons following the instructions provided in the package insert. The study included men testing at home with their own semen samples as well as both men and women performing the test on provided semen samples. These studies included a lay vs. professional comparison and a comparison to microscopic counts. Ease of use was also evaluated with a questionnaire.

SpermCheck Vasectomy was tested by an ethnically and socio-economically diverse cohort of 109 participants. In every case, these lay users obtained the expected test result (or the same result as a professional user testing the same sample). Over 97% of the questionnaire responses were correct, indicating that SpermCheck Vasectomy is easy to use.