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Recommendations for gam and embryo donation: an d t Tec e a olo nda yte est etic t in se C A all ilia uid Pra Fer ;99 epr cu its a ttp dat more consistent and incorporates recent such as serologic tests. Thedistinctionbe- ting of the recipients of donated etes, the American Society for roductive Medicine (ASRM) recom- tionally, state requirements may be FDA, and check with state where determine e- a- ht n, of y v- o- sue Banks (AATB). The risks for trans- mission of STIs via donations of sperm, oocytes, and embryos differ, and leukocyte-rich semen donation poses nors apply to potential donors in the United States. Because the prevalence of STIs and genetic diseases may vary in other locales, these guidelines may minimum screening and testing r quirements for their state. The promulgation of FDA regul tions has added considerable oversig to gamete and embryo donatio including mandatory registration all assisted reproductive technolog (ART) programs with the federal go ernment, federal inspections of pr Received September 19, 2012; accepted September 21, 2012; published online October 22, 2012. No reprints will be available. Correspondence: Practice Committee, American Society for Reproductive Medicine, 1209 Montgom- ery Hwy., Birmingham, AL 35216 (E-mail: ASRM@asrm.org). information from the US Centers for Disease Control and Prevention (CDC), US Food and Drug Administration (FDA), and American Association of Tis- tween screening and testing is consistent within the document. These guidelines for the screening and testing of gamete and embryo do- more restrictive than the clinics are encouraged to government officials in the their practice is located to mitted infections (STIs), genetic dis- eases, and psychological assessments. The current document represents an ef- fort to make the screening guidelines for donors of embryos and gametes risk for a given disease, such as human immunodeficiency virus (HIV), transmis- sible spongiform encephalopathy (TSE), or Creutzfeldt-Jakob disease (CJD). ‘‘Test- ing’’ refers to specific laboratory studies mends testing of recipients as described. Other areas where the ASRM recommendations may be more stringent than the FDA minimum re- quirements are noted in the text. Addi- T he 2012 Recommendations forGamete and Embryo Donationprovide the latest recommenda- tions for evaluation of potential sperm, oocyte, and embryo donors, incorporat- ing recent information about optimal screening and testing for sexually trans- unique risks that are reflected in the recommendations. These guidelines use terminology from the federal agencies in addition to the AATB. In that context, the term ‘‘screening’’ refers to specific historical factors thatplacean individual at ahigher not or Sta the tes gam Rep be appropriate for other countries individuals who come to the United tes from other countries. Whereas FDA does not require screening or committee-opinion/ * Download a free QR code scanner by searching for “QR scanner” in your smartphone’s app store or app marketplace. a committee The Practice Committee of the Americ the Society for Assisted Reproductive American Society for Reproductive Medicin This document provides the latest recomme information about optimal screening and t This revised document incorporates recen Drug Administration, and the American donation services must be thoroughly fam lines for Gamete and Embryo Donation: A Steril 2008;90:S30–44. (Fertil Steril� 2013 ductive Medicine.) Earn online CME credit related to this do Discuss: You can discuss this article with fertstertforum.com/goldsteinj-recommen Fertility and Sterility® Vol. 99, No. 1, January 2013 0 Copyright ©2013 American Society for Reproductive http://dx.doi.org/10.1016/j.fertnstert.2012.09.037 VOL. 99 NO. 1 / JANUARY 2013 opinion Society for Reproductive Medicine an hnology nd Society for Assisted Reproductive Techn tions for evaluation of potential sperm, ooc ing for sexually transmitted infections, gen formation from the U.S. Centers for Disea ssociation of Tissue Banks, with which r, and replaces the document titled, ‘‘2008 G ctice Committee Report,’’ last published in :47–62. �2013 by American Society for R ment at www.asrm.org/elearn uthors and with other ASRM members at h ions-gamete-and-embryo-donation- 015-0282/$36.00 Medicine, Published by Elsevier Inc. ete he Practice Committee of gy, Birmingham, Alabama , and embryo donors, incorporating recent diseases, and psychological assessments. ontrol and Prevention, the US Food and programs offering gamete and embryo e- til o- :// Use your smartphone to scan this QR code and connect to the discussion forum for this article now.* grams that are performing donation, required documentation, and written 47 T a T a re m (H re s o lo c re in w II. I IV. V. ASRM PAGES abnormalities. B. The male partner has ejaculatory dysfunction. C. The male partner demonstrates significant male factor infertility (i.e., significant oligoasthenospermia or prior failure to fertilize after insemination in vitro and intracytoplasmic sperm injection [ICSI] is not elected or feasible). D. Themale partner has a significant genetic defect or the couple previously has produced an offspring affected by a condition for which carrier status cannot be determined. E. The male partner has a sexually transmissible infec- tion that cannot be eradicated. F. The female partner is Rh-negative and severely Rh- isoimmunized and the male partner is Rh-positive. G. Females without male partners. III. Psychological consultation for recipients The decision to proceed with donor insemination is com- plex, and patients and their partners (if applicable) may benefit from psychological counseling to aid in this deci- sion. The clinician should strongly recommend psycho- logical counseling by a qualified mental health professional to all donor sperm recipients and their part- ners. The assessment should include a clinical interview and, where appropriate, psychological testing. The clini- cian should require psychological consultation for cou- ples in whom factors appear to warrant further evaluation. In cases of directed donation, the potential 48 herapeutic donor insemination (TDI) may be used to chieve pregnancy where appropriate indications exist. he clinical procedures should take into account the age nd health status of the recipient. The FDA has published quirements for the screening and testing of donors of hu- an cells, tissues, and cellular and tissue-based products CT/Ps), which are included here. These are the minimum quirements mandated by the federal government. In ome instances, the federal requirements may be less rigor- us than those in the state in which an individual practice is cated or than those recommended by ASRM and the So- iety for Assisted Reproductive Technology (SART). It is the sponsibility of all clinics to know the regulations of their dividual states and local municipalities and to comply ith those standards. ndications for TDI A. The male partner has azoospermia, severe oligozoo- spermia, or other significant sperm or seminal fluid protocols attendant to donor screening, testing, selection, re- jection, and follow-up. Complete records of all donor cycles, including documentation of adherence to FDA regulations, must be made available to FDA inspectors at their request. Federal regulations may be viewed at the followingWeb sites: http://www.fda.gov/cber/tiss.htm http://www.fda.gov/BiologicsBloodVaccines/default.htm http://www.fda.gov/cber/rules/gtp.pdf GUIDELINES FOR SPERM DONATION I. Introduction impact of the relationship between the donor and recipi- counseling: 1. Although there are no federal requirements for test- ing donor sperm recipients, the following tests are recommended: B. Human immunodeficiency virus (HIV-1 antibody [AB] and nucleic acid testing [NAT]), HIV-2 AB testing and screening, or testing for HIV group O antibodies on the male partner is strongly recommended. If the male partner is HIV infected, he should be referred to an ap- propriate infectious disease specialist for counseling on safe sex practices for preventing HIV transmission, on treatment options, and on other issues concerning HIV disease. A positive HIV test result for the male partner should not be used as an exclusionary crite- rion for treatment of a couple with TDI. C. Testing for other STIs similar to that recommended for the female partner (detailed in section V) is encour- aged. This includes: 1. Serologic test for syphilis. 2. Hepatitis B surface antigen. 3. Hepatitis B core antibody (IgG and IgM). 4. Hepatitis C antibody and NAT. 5. Neisseria gonorrhoeae and Chlamydia trachomatis NAT on urine or a swab obtained from the urethral meatus. Note: There are no FDA-licensed, approved, or cleared tests for donor screening of these organisms in an asymptomatic, low-prevalence population. Tests using NAT technology adequately and appropriately reduce the risk of transmission of these relevant communica- ble agents. 6. Human T-cell lymphotropic virus (HTLV) type I and II also may be obtained at the discretion of the clinician in the appropriate clinical setting. Evaluation of the female recipient A. Routine medical and reproductive history should be obtained according to the standards that are applied to women anticipating pregnancy. Abnormalities detected from history or physical examination may require more detailed evaluation and treatment before proceeding with insemination. B. A complete general physical examination should be performed, including a pelvic examination. C. Standard preconceptional screening, testing, and TDI. ent should be explored, as well as any plans that may exist relating to disclosure and future contact. Evaluation of the partner A. The partner in any couple that requests TDI should have completed an appropriate clinical evaluation. Medical records should be reviewed before performing the insemination procedure. If appropriate, alternative treatments should be discussed with the couple. While not required by the FDA, infectious disease testing of the male partner is recommended by the ASRM to ad- dress any potential medical/legal issues that could arise should the partner seroconvert during or after a. Blood type, Rh factor, and antibody screen. VOL. 99 NO. 1 / JANUARY 2013 D. D 1. E. Ev ab F. Pa se ra to G VI. D A VOL. 99 NO Fertility and Sterility® ferred to an appropriate infectious disease spe- cialist for counseling on issues concerning HIV disease, including reproductive issues such as safe sex practices for preventing HIV transmis- sion to uninfected partners and treatment op- tions to reduce the probability of transmission to her child. A positive HIV test of the female re- cipient should not be used as an exclusionary cri- terion for treatment with TDI as long as the couple makes an informed decision after coun- seling and agrees to comply with recommended clinical management for the positive HIV status during pregnancy. e. Serologic test for syphilis. f. Hepatitis B surface antigen. g. Hepatitis B core antibody (IgG and IgM). h. Hepatitis C antibody and NAT. i. Cytomegalovirus (CMV) antibody (IgG and IgM). For women who test positive for active infection (positive urine or throat culture or paired serum samples demonstrating a four-fold rise in IgG anti- body and IgM antibody at least 30% of the IgG level), attempts to conceive should be postponed until they no longer exhibit active infection, owing to the risk of transmitting the infection to their fe- tus and the serious potential consequences of fetal CMV infection. j. HTLV type I and II alsomay be obtained at the dis- cretion of the clinician in the appropriate clinical setting. ocumentation and timing of ovulation Womenwith regular cyclicmenses andmolimina are assumed to be ovulating. When doubt exists, an in- dex of ovulation, such as serum progesterone level, basal body temperature recordings, LH surge detec- tion, and ultrasound monitoring of follicular matu- ration, may be used to document ovulation. Appropriate timing of the insemination procedure optimizes chances for success. aluation for possible tubal or peritoneal normalities tients who fail to conceive after 4 to 6well-timed in- minations may be candidates for hysterosalpingog- phy (HSG), laparoscopy, or other appropriate tests b. Rubella and varicella titers. Vaccination should be offered if the individual is not immune to ei- ther virus. c. Neisseria gonorrhoeae and Chlamydia trachoma- tis NAT on urine or a swab obtained from the cer- vix, urethral meatus, or vagina. d. HIV-1 (AB and NAT), HIV-2 AB testing, and test- ing or screening for HIV group O antibodies should be performed to address potential medi- cal/legal complications that could arise if the re- cipient seroconverts during or after treatment. In addition, if the female recipient is found to be HIV-infected before treatment, she should be re- detect possible causes for their failure to conceive. . 1 / JANUARY 2013 2. Genetic evaluation Genetic screening for heritable diseases should be performed in potential sperm donors. Testing for cystic fibrosis carrier status should be performed on all donors. Other genetic testing should be per- can be applied (1). mended for all sperm donors. The assessment should include a clinical interview and, where ap- propriate, psychological testing. Psychological con- sultation should be required for individuals in whom there appear to be factors that warrant further eval- uation. In cases of directed donation, psychological evaluation and counseling are strongly recommen- ded for the donor and his partner (if applicable) as well as for the recipient female and her partner (if ap- plicable). The potential impact of the relationship between the donor and recipient should be explored. The psychological assessment also should address the potential psychological risks and evaluate for ev- idence of coercion (financial or emotional). It is im- portant to ascertain whether the donor is well informed about the extent to which information about him might be disclosed and about any plans that may exist relating to future contact. 5. No owner, operator, laboratory director, or em- ployee of a facility performing TDI may serve as a donor in that practice. 6. Neither the patient's physician nor the individual performing the actual insemination can be the sperm donor. B. Screening and testing of donors 1. Semen testing a. It is suggested that more than one sample be ex- amined (each after a 2- to 5-day abstinence inter- val) before proceeding with a more extensive evaluation of the donor candidate. b. The sample should be examined within 1 to 2 hours after ejaculation into a sterile container. The criteria used to judge the normality of the sample can vary among laboratories. There are no uniformly accepted standards, but, in general, the minimum criteria for normal semen quality Pretreatment HSG or laparoscopy may be indicated by the history and/or physical findings. . Informed consent should be obtained from the patient (and her partner, if applicable). onors . Selection of donor 1. The main qualities to seek in selecting a donor for TDI are an assurance of good health status and the absence of known genetic abnormalities. 2. The donor should be of legal age and, ideally, less than 40 years of age. 3. Selection of donors with established fertility is desir- able but not required. 4. Psychological evaluation and counseling by a quali- fied mental health professional is strongly recom- formed as indicated by the donor's ethnic 49 bac dat Ch req ing 3. Me a. b. 50 ASRM PAGES 12 months through percutaneous inocula- tion or contact with an open wound, non- intact skin, or mucous membrane to blood that is known or suspected to be infected with HIV, hepatitis B, and/or hepatitis C virus. viii. Men who have had close contact (e.g., liv- ing in the same household wherein shar- ing of kitchen and bathroom facilities occurs regularly) within 12 months pre- ceding the donation with another person who has hepatitis B or clinically active (symptomatic) hepatitis C infection. ix. Men who have been incarcerated in lock- up, jail, or prison for more than 72 consec- utive hours within the previous 12months. x. Menwho have had or have been treated for kground in accordance with current recommen- ions after obtaining a proper family history. romosomal analyses on all sperm donors are not uired (see Appendix A for further details regard- genetic screening and testing) (2–4). dical history Donors should be healthy and give no history to suggest hereditary disease. A complete personal and sexual history should be obtained to exclude as donors individuals who might be at high risk for HIV, STIs, or other infec- tions that might be transmissible via gamete do- nation. Prospective sperm donors with any of the following factors should not be accepted (for a complete list of screening questions, see ‘‘Uni- form Donor Application’’ at www.sart.org): i. Men with a history of sex with another man in the preceding 5 years. ii. Men who have injected drugs for non- medical reasons in the preceding 5 years, including intravenous, intramuscular, and subcutaneous injections. iii. Men with hemophilia or other related clotting disorders who have received human-derived clotting factor concen- trates in the preceding 5 years. iv. Men who received clotting factors once to treat an acute bleeding event more than 12 months ago may be eligible to donate. v. Men who have had sex in exchange for money or drugs in the preceding 5 years. vi. Menwho have had sex in the preceding 12 months with any person meeting any of the criteria described immediately above, or with any person having HIV infection, including a positive or reactive test to HIV virus, hepatitis B infection, or clini- cally active (symptomatic) hepatitis C infection. vii. Menwhohave been exposedwithin the last syphilis, gonorrhea, or chlamydia within the preceding 12 months. Deferral of do- nors is not necessary when there is evi- dence of successful treatment more than 12 months before. xi. Men who have undergone body piercing and/or tattooing procedureswithin the pre- ceding 12 months in which sterile proce- dures were not used or it is unclear whether sterile procedures were used (e.g., contaminated instruments and/or ink were used, or shared instruments that had not been sterilized between uses were used). xii. Men who have received a smallpox vacci- nation (vaccinia virus) for 21 days after vaccination or until the scab separates spontaneously and physical examination confirms the absence of a scab at the vac- cination site (whichever is later). The do- nor should be deferred for 2 months if the scab was removed before spontaneous separation. If the donor experienced com- plications from vaccination, he should be deferred until 14 days after complete res- olution of those complications. If the do- nor became infected as a result of close contact with a person recently vaccinated for vaccinia, he may be considered eligi- ble for donation if the scab spontaneously separated, if 14 days have elapsed since resolution of all the vaccinia-related com- plications, or 3 months after the scab was otherwise removed. xiii. Men who have had a medical diagnosis or suspicion of West Nile virus (WNV) infec- tion (based on symptoms and/or labora- tory results or confirmed WNV viremia) should be deferred for 120 days after the onset of symptoms or diagnosis, which- ever is later. xiv. Men who have tested positive or reactive for WNV infection using an FDA- licensed or investigational WNV NAT in the preceding 120 days. xv. Men who have been diagnosed with var- iant CJD (vCJD) or any other form of CJD. xvi. Men who have been diagnosed with de- mentia or any other degenerative or de- myelinating disease of the central nervous system or other neurologic dis- e