- Email: [email protected]
Appendix A Selection and screening of donors
Appendix A Selection and screening of donors*
The following guidelines for screening potential semen donors represent a conservative approach with the aim of minimizing false negatives. The key feature is the establishment of a solid rapport with potential donors and the acquisition of an in-depth knowledge of their health status. Local conditions differ and may dictate approaches different from those provided in these guidelines. INITIAL VISIT
I. Historical screening (for exclusion purposes) A. Identification of AIDS risk groups 1. Men with any homosexual contact in the last 8 years 2. Intravenous drug users 3. Sexual partners of persons in AIDS risk groups
* The following committee provided consultation with respect to those portions that pertain to sexually transmitted diseases: King K. Holmes, M.D., Ph.D. Chief of Medicine, Harborview Medical Center Chairman and Professor of Medicine University of Washington School of Medicine Ruth Greenblatt, M.D. Senior Fellow, Division oflnfectious Diseases, Department of Medicine University of Washington School of Medicine H. Hunter Handsfield, M.D. Director, Sexually Transmitted Diseases Clinic Seattle-King County Department of Public Health Associate Professor of Medicine University of Washington School of Medicine Merlyn H. Sayers, M.D. Director, Puget Sound Blood Center Assistant Professor of Medicine University of Washington School of Medicine Lawrence Corey, M.D. Professor of Laboratory Medicine and Medicine Head, Virology Division University of Washington School of Medicine Vol. 53, No.3, March 1990
4. Donors from geographic areas where sex ratio of AIDS patients is close to 1:1 B. More than one sexual partner within 6 months C. Evidence of STD within last 6 months 1. Dysuria 2. Urethral discharge 3. Genital ulcer 4. Hepatitis 5. Sexual partner with frequent episodes of Trichomonas D. Any past history of: 1. Genital herpes 2. Genital warts 3. Chronic hepatitis II. If the history is negative for exclusion factors, then obtain blood for CMV serology. If theresults are positive, some investigators believe that the donor may be used for artificial insemination if the recipient is also CMV -positive. However, other investigators believe that this is too risky, because there are multiple strains of CMV, and the present serologic tests do not distinguish among them. Thus, the CMV -positive woman could still be vulnerable to infection from the semen of a CMV -positive man if different strains of CMV were involved. Because the consequences of CMV to neonatal health are serious, special attention should be paid to this issue. Second Visit: If the history is satisfactory and the CMV serology is negative, proceed with the following: III. Physical examination A. Make certain that there is no: 1. Urethral discharge 2. Genital wart 3. Genital ulcer Supplement 1
68
B. Perform urethral cultures 1. Neisseria gonorrhoeae 2. Chlamydia trachomatis 3. Mycoplasma hominis (Optional: some investigators are concerned about mycoplasma and its adverse impact on the reproductive system and on fertility) 4. Trichomonas vagina/is (Optional: if there is doubt about the history) 5. White blood cell count (Optional: some investigators perform a wet preparation of seminal fluid and stain for white blood cells [WBCs]. If there are more than 10 WBCs per high-power field, cultures for STD should be performed. The donor should be reexamined at 6-month intervals when follow-up cultures and blood tests are obtained. C. Serology 1. Hepatitis-B surface antigen and core antibody 2. HIV (EIA). A positive assay should be verified with a confirmatory test such as Western Blot (or newer tests as they become available) before the potential donor is notified. If the test is negative, semen samples may be collected and prepared for cryopreservation. The donor should be tested again in 180 days for HIV and the specimen released for use only if the results are negative.
7S
Supplement 1
3. Serologic test for syphilis 4. Serum antibody tests for CMV. If antibody tests are negative, the donor should have CMV titers done at 6month intervals and the quarantined specimen not released if there is a significant increase in the titer suggesting recent CMV infection. The donor should also be monitored for any development of heterophile negative mononucleosis-type illness. SURVEILLANCE
IV. Follow-up A. Exclude donors; discontinue donors 1. Symptomatic for STD a. Genital warts b. Genital herpes c. Genital ulcer d. Urethral discharge 2. With new sexual partners or if there is a break in monogamy or abstinence B. Rescreen donors every 6 months at minimum C. Evaluate and follow up recipients per protocol; track any evident STD transmission to donor and his recipients, as in blood banking
Fertility and Sterility
The following guidelines for screening potential semen donors represent a conservative approach with the aim of minimizing false negatives. The key feature is the establishment of a solid rapport with potential donors and the acquisition of an in-depth knowledge of their health status. Local conditions differ and may dictate approaches different from those provided in these guidelines. INITIAL VISIT
I. Historical screening (for exclusion purposes) A. Identification of AIDS risk groups 1. Men with any homosexual contact in the last 8 years 2. Intravenous drug users 3. Sexual partners of persons in AIDS risk groups
* The following committee provided consultation with respect to those portions that pertain to sexually transmitted diseases: King K. Holmes, M.D., Ph.D. Chief of Medicine, Harborview Medical Center Chairman and Professor of Medicine University of Washington School of Medicine Ruth Greenblatt, M.D. Senior Fellow, Division oflnfectious Diseases, Department of Medicine University of Washington School of Medicine H. Hunter Handsfield, M.D. Director, Sexually Transmitted Diseases Clinic Seattle-King County Department of Public Health Associate Professor of Medicine University of Washington School of Medicine Merlyn H. Sayers, M.D. Director, Puget Sound Blood Center Assistant Professor of Medicine University of Washington School of Medicine Lawrence Corey, M.D. Professor of Laboratory Medicine and Medicine Head, Virology Division University of Washington School of Medicine Vol. 53, No.3, March 1990
4. Donors from geographic areas where sex ratio of AIDS patients is close to 1:1 B. More than one sexual partner within 6 months C. Evidence of STD within last 6 months 1. Dysuria 2. Urethral discharge 3. Genital ulcer 4. Hepatitis 5. Sexual partner with frequent episodes of Trichomonas D. Any past history of: 1. Genital herpes 2. Genital warts 3. Chronic hepatitis II. If the history is negative for exclusion factors, then obtain blood for CMV serology. If theresults are positive, some investigators believe that the donor may be used for artificial insemination if the recipient is also CMV -positive. However, other investigators believe that this is too risky, because there are multiple strains of CMV, and the present serologic tests do not distinguish among them. Thus, the CMV -positive woman could still be vulnerable to infection from the semen of a CMV -positive man if different strains of CMV were involved. Because the consequences of CMV to neonatal health are serious, special attention should be paid to this issue. Second Visit: If the history is satisfactory and the CMV serology is negative, proceed with the following: III. Physical examination A. Make certain that there is no: 1. Urethral discharge 2. Genital wart 3. Genital ulcer Supplement 1
68
B. Perform urethral cultures 1. Neisseria gonorrhoeae 2. Chlamydia trachomatis 3. Mycoplasma hominis (Optional: some investigators are concerned about mycoplasma and its adverse impact on the reproductive system and on fertility) 4. Trichomonas vagina/is (Optional: if there is doubt about the history) 5. White blood cell count (Optional: some investigators perform a wet preparation of seminal fluid and stain for white blood cells [WBCs]. If there are more than 10 WBCs per high-power field, cultures for STD should be performed. The donor should be reexamined at 6-month intervals when follow-up cultures and blood tests are obtained. C. Serology 1. Hepatitis-B surface antigen and core antibody 2. HIV (EIA). A positive assay should be verified with a confirmatory test such as Western Blot (or newer tests as they become available) before the potential donor is notified. If the test is negative, semen samples may be collected and prepared for cryopreservation. The donor should be tested again in 180 days for HIV and the specimen released for use only if the results are negative.
7S
Supplement 1
3. Serologic test for syphilis 4. Serum antibody tests for CMV. If antibody tests are negative, the donor should have CMV titers done at 6month intervals and the quarantined specimen not released if there is a significant increase in the titer suggesting recent CMV infection. The donor should also be monitored for any development of heterophile negative mononucleosis-type illness. SURVEILLANCE
IV. Follow-up A. Exclude donors; discontinue donors 1. Symptomatic for STD a. Genital warts b. Genital herpes c. Genital ulcer d. Urethral discharge 2. With new sexual partners or if there is a break in monogamy or abstinence B. Rescreen donors every 6 months at minimum C. Evaluate and follow up recipients per protocol; track any evident STD transmission to donor and his recipients, as in blood banking
Fertility and Sterility