Men are missing in action when it comes to post-vasectomy testing
Men are missing in action when it comes to post-vasectomy testing
New at-home test eyed to help men check sperm post-vasectomy
Check the statistics for post-vasectomy follow-up tests at your family planning clinic. How many men are returning for semen analysis following their sterilization procedures?
A new study indicates that 25% of men who had vasectomies at the Glickman Urological Institute at Cleveland Clinic provided no follow-up semen specimens, and only 21% followed the full instructions to provide two consecutive negative semen analyses.1 An earlier study indicates similar results and shows that 34% of men never returned to a Michigan private urological practice following their sterilization procedures.2
About 500,000 men receive a vasectomy in the United States each year; in contrast, 700,000 women receive a tubal sterilization.3 Protocols for ensuring azoospermia vary among providers. In a national survey, 56% of physicians said they require one post-vasectomy semen specimen, while 39% require two, and 5% ask for three or more.3
Physicians participating in the Cleveland Clinic study typically recommend that patients have their semen tested for sperm at least twice, at eight and 12 weeks, following their procedures.1 The current study included 436 men who got vasectomies at the Cleveland facility and were told to submit two semen samples two months after vasectomy and again a month later. If the samples contained sperm, the men were instructed to submit monthly semen samples until two consecutive negative tests were achieved.
Three-quarters of the patients provided a semen specimen at eight weeks after vasectomy; of these, 75% were azoospermic and 25% contained sperm. At 12 weeks after vasectomy, half the patients provided a semen specimen; of these, 91% were azoospermic and 9% contained sperm.1
J. Stephen Jones, MD, vice chairman of the Glickman Urological Institute and director of the study, says his facility now has found success by asking for just one specimen at three months post-procedure. Patients are scheduled for a three-month appointment, rather than being told simply to come in at three months and bring a specimen. Patients like the change because it calls for just one visit, and in turn, providers are seeing increased compliance, says Jones.
"If we don't confirm patients are sterile and especially if they don't follow up on that, then we fail to serve them well," says Jones.
Although vasectomy is the most effective type of all contraceptive approaches, it is not 100% effective. Commonly quoted failure rates range from 0.1% to 0.4%.4 In a vasectomy, a small portion of the tubes that carry sperm from the testicles, known as the vasa deferentia, are cut and sealed. This prevents pregnancy because no sperm can get into the ejaculate. Rare failures occur because the initial procedure is not done properly or because recanalization occurs. Instructions for patients in A Pocket Guide to Managing Contraception suggest that other forms of contraception be used until two consecutive sperm samples show no motile sperm. Furthermore, to avoid failure due to late recanalization, "repeating semen analysis every few years makes sense," the book states.5
About 30% of the vasectomy procedures performed in the United States are no-scalpel vasectomies. This technique, developed in China, has been in use in the United States since 1988. The no-scalpel approach does not make a cut in the skin; it uses a special instrument to make one small puncture. Providers have found the technique is less traumatic, causes less pain and swelling, and results in a shorter recovery time. In the United States, about 30% of vasectomies are the no-scalpel type.
No matter which technique is used to perform a vasectomy, success of the procedure can be determined only by a semen analysis that is negative for sperm.6
During patient counseling, providers should emphasize that pregnancy prevention is not assured until at least one semen analysis is negative. [Editor's note: A vasectomy handout is available with the on-line version of Contraceptive Technology Update. If you're accessing your on-line account for the first time, go to www.ahcpub.com. Click on the "Activate Your Subscription" tab in the left-hand column. Then follow the easy steps under "Account Activation." If you already have an on-line subscription, go to www.ahcpub.com. Select the tab labeled "Subscriber Direct Connect to Online Newsletters. Please select an archive." Choose "Contraceptive Technology Update," and then click "Sign on" from the left-hand column to log in. Once you're signed in, select "2006" and then select the July 2006 issue. For assistance, call Customer Service at (800) 688-2421.]Until the negative analysis is obtained, another contraceptive method must be used.6 When providing an outline of preoperative and postoperative instructions, providers should include the protocol and schedule for postoperative semen analysis in the postoperative instructions.6
Use of informed consent is key in any sterilization procedure.5 Review your consent form to see that it contains language documenting the patient's knowledge of the following points:
- Temporary contraception is available.
- Vasectomy should be considered permanent. If the vasectomy is successful, the patient will be unable to father children.
- Vasectomy is surgery.
- Vasectomy has risks and benefits. Among the risks are possible complications resulting from the procedure. (Optional: List possible complications.)
- Vasectomy has a risk of failure. Sterility cannot be guaranteed. (Optional: List risk of failure.)
- The patient must use another method of contraception during the postoperative period until a negative semen analysis has been obtained. (Optional: Give schedule for postoperative semen analysis.)6
Despite the importance of the semen analysis, many men don't return for the follow-up visit. Reasons for noncompliance include inconvenience, embarrassment, and forgetfulness.7
What if men could check their sperm with an at-home test? ContraVac, a firm in Charlottesville, VA, is developing just such a test. Clinical trial studies to determine the effectiveness of the SpermCheck Vasectomy test compared to microscopic counts have recently begun, says Ed Leary, ContraVac president. Clinical studies are expected to be completed by the end of August, and the company expects to file an application with the Food and Drug Administration (FDA) in September to market the test as an over-the-counter device, he reports. Publication of the results of the clinical studies is planned in late 2006, Leary adds.
ContraVac was formed to commercialize technology resulting from work under way at the Charlottesville-based University of Virginia's Center for Research in Contraceptive and Reproductive Health, which is directed by John Herr, PhD, professor of cell biology and urology at the university. Products under development at ContraVac use the SP-10 antigen unique to sperm. SpermCheck features an immunological assay that identifies SP-10 in the head of sperm.
If approved, SpermCheck Vasectomy will offer an inexpensive, convenient, and private option for men, Leary states. The company is aiming to market the test for about $30 at pharmacies and mass merchandisers, as well as via the Internet.
"We expect SpermCheck Vasectomy to be rapidly accepted and endorsed by the medical community as the ideal test for the second post-vasectomy sperm test and all subsequent testing for recanalization," Leary says. Increased patient compliance will be the primary reason for this endorsement, he says. "Ultimately, we envision SpermCheck Vasectomy being the standard for all post-vasectomy sperm testing once it has demonstrated its utility as a simple, accurate, economical, and private sperm test device," Leary says.
References
- Dhar NB, Bhatt A, Jones JS. Determining the success of vasectomy. BJU Int 2006; 97:773-776.
- Maatman TJ, Aldrin L, Carothers GG. Patient noncompliance after vasectomy. Fertil Steril 1997; 68:552-555.
- Haws JM, Morgan GT, Pollack AE, et al. Clinical aspects of vasectomies performed in the United States in 1995. Urology 1998; 52:685-691.
- Hatcher RA, Trussell J, Stewart F, et al. Contraceptive Technology: 18th revised edition. New York City: Ardent Media; 2004.
- Hatcher RA, Zieman M, Cwiak C, et al. A Pocket Guide to Managing Contraception. Tiger, GA: Bridging the Gap Foundation; 2005.
- Haws JM, Feigin J. Vasectomy counseling. Am Fam Physician 1995; 52:1,395-1,399.
- Smucker DR, Mayhew HE, Nordlund DJ, et al. Post-vasectomy semen analysis: Why patients don't follow-up. J Am Board Fam Pract 1991; 4:5-9.
Resource
For more information on SpermCheck Vasectomy, contact:
- Ed Leary, ContraVac, P.O. Box 4608, Charlottesville, VA 22905. Telephone: (434) 243-9205. Fax: (434) 243-9206. E-mail: [email protected]. Web: www.contravac.com.
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