embryo donation

17 Pages·2012·0.16 MB·English

Recommendations for gamete
and embryo donation:
a committee opinion
The Practice Committee of the American Society for Reproductive Medicine and the Practice Committee of
the Society for Assisted Reproductive Technology
American Society for Reproductive Medicine and Society for Assisted Reproductive Technology, Birmingham, Alabama
This document provides the latest recommendations for evaluation of potential sperm, oocyte, and embryo donors, incorporating recent
information about optimal screening and testing for sexually transmitted infections, genetic diseases, and psychological assessments.
This revised document incorporates recent information from the U.S. Centers for Disease Control and Prevention, the US Food and
Drug Administration, and the American Association of Tissue Banks, with which all programs offering gamete and embryo
donation services must be thoroughly familiar, and replaces the document titled, ‘‘2008 Guide-
lines for Gamete and Embryo Donation: A Practice Committee Report,’’ last published in Fertil
Steril 2008;90:S30–44. (Fertil SterilÒ 2013;99:47–62. Ó2013 by American Society for Repro- Use your smartphone
ductive Medicine.) to scan this QR code
Earn online CME credit related to this document at www.asrm.org/elearn and connect to the
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he 2012 Recommendations for unique risks that are reflected in the not be appropriate for other countries
Gamete and Embryo Donation recommendations. or individuals who come to the United
Tprovide the latest recommenda- These guidelines use terminology States from other countries. Whereas
tions for evaluation of potential sperm, from the federal agencies in addition to the FDA does not require screening or
oocyte, and embryo donors, incorporat- the AATB. In that context, the term testing of the recipients of donated
ing recent information about optimal ‘‘screening’’ refers to specific historical gametes, the American Society for
screening and testing for sexually trans- factors thatplacean individual at ahigher Reproductive Medicine (ASRM) recom-
mitted infections (STIs), genetic dis- risk for a given disease, such as human mends testing of recipients as
eases, and psychological assessments. immunodeficiency virus (HIV), transmis- described. Other areas where the
The current document represents an ef- sible spongiform encephalopathy (TSE), ASRM recommendations may be more
fort to make the screening guidelines or Creutzfeldt-Jakob disease (CJD). ‘‘Test- stringent than the FDA minimum re-
for donors of embryos and gametes ing’’ refers to specific laboratory studies quirements are noted in the text. Addi-
more consistent and incorporates recent such as serologic tests. Thedistinctionbe- tionally, state requirements may be
information from the US Centers for tween screening and testing is consistent more restrictive than the FDA, and
Disease Control and Prevention (CDC), within the document. clinics are encouraged to check with
US Food and Drug Administration These guidelines for the screening government officials in the state where
(FDA), and American Association of Tis- and testing of gamete and embryo do- their practice is located to determine
sue Banks (AATB). The risks for trans- nors apply to potential donors in the minimum screening and testing re-
mission of STIs via donations of sperm, United States. Because the prevalence quirements for their state.
oocytes, and embryos differ, and of STIs and genetic diseases may vary The promulgation of FDA regula-
leukocyte-rich semen donation poses in other locales, these guidelines may tions has added considerable oversight
to gamete and embryo donation,
Received September 19, 2012; accepted September 21, 2012; published online October 22, 2012. including mandatory registration of
No reprints will be available. all assisted reproductive technology
Correspondence: Practice Committee, American Society for Reproductive Medicine, 1209 Montgom-
ery Hwy., Birmingham, AL 35216 (E-mail:
ASRM PAGES
protocols attendant to donor screening, testing, selection, re- ent should be explored, as well as any plans that may exist
jection, and follow-up. Complete records of all donor cycles, relating to disclosure and future contact.
including documentation of adherence to FDA regulations, IV. Evaluation of the partner
must be made available to FDA inspectors at their request. A. The partner in any couple that requests TDI should
Federal regulations may be viewed at the followingWeb sites: have completed an appropriate clinical evaluation.
http://www.fda.gov/cber/tiss.htm Medical records should be reviewed before performing
http://www.fda.gov/BiologicsBloodVaccines/default.htm the insemination procedure. If appropriate, alternative
http://www.fda.gov/cber/rules/gtp.pdf treatments should be discussed with the couple. While
not required by the FDA, infectious disease testing of
GUIDELINES FOR SPERM DONATION
the male partner is recommended by the ASRM to ad-
dress any potential medical/legal issues that could
I. Introduction
arise should the partner seroconvert during or after
Therapeutic donor insemination (TDI) may be used to
TDI.
achieve pregnancy where appropriate indications exist.
B. Human immunodeficiency virus (HIV-1 antibody [AB]
The clinical procedures should take into account the age
and nucleic acid testing [NAT]), HIV-2 AB testing and
and health status of the recipient. The FDA has published
screening, or testing for HIV group O antibodies on the
requirements for the screening and testing of donors of hu-
male partner is strongly recommended. If the male
man cells, tissues, and cellular and tissue-based products
partner is HIV infected, he should be referred to an ap-
(HCT/Ps), which are included here. These are the minimum
propriate infectious disease specialist for counseling
requirements mandated by the federal government. In
on safe sex practices for preventing HIV transmission,
some instances, the federal requirements may be less rigor-
on treatment options, and on other issues concerning
ous than those in the state in which an individual practice is
HIV disease. A positive HIV test result for the male
located or than those recommended by ASRM and the So-
partner should not be used as an exclusionary crite-
ciety for Assisted Reproductive Technology (SART). It is the
rion for treatment of a couple with TDI.
responsibility of all clinics to know the regulations of their
C. Testing for other STIs similar to that recommended for
individual states and local municipalities and to comply
the female partner (detailed in section V) is encour-
with those standards.
aged. This includes:
II. Indications for TDI
1. Serologic test for syphilis.
A. The male partner has azoospermia, severe oligozoo-
2. Hepatitis B surface antigen.
spermia, or other significant sperm or seminal fluid
3. Hepatitis B core antibody (IgG and IgM).
abnormalities.
4. Hepatitis C antibody and NAT.
B. The male partner has ejaculatory dysfunction.
5. Neisseria gonorrhoeae and Chlamydia trachomatis
C. The male partner demonstrates significant male factor
NAT on urine or a swab obtained from the urethral
infertility (i.e., significant oligoasthenospermia or
meatus.
prior failure to fertilize after insemination in vitro
and intracytoplasmic sperm injection [ICSI] is not Note: There are no FDA-licensed, approved, or cleared
elected or feasible). tests for donor screening of these organisms in an
D. Themale partner has a significant genetic defect or the asymptomatic, low-prevalence population. Tests using
couple previously has produced an offspring affected NAT technology adequately and appropriately reduce
by a condition for which carrier status cannot be the risk of transmission of these relevant communica-
determined. ble agents.
E. The male partner has a sexually transmissible infec- 6. Human T-cell lymphotropic virus (HTLV) type I
tion that cannot be eradicated. and II also may be obtained at the discretion of
F. The female partner is Rh-negative and severely Rh- the clinician in the appropriate clinical setting.
isoimmunized and the male partner is Rh-positive. V. Evaluation of the female recipient
G. Females without male partners. A. Routine medical and reproductive history should be
III. Psychological consultation for recipients obtained according to the standards that are applied
The decision to proceed with donor insemination is com- to women anticipating pregnancy. Abnormalities
plex, and patients and their partners (if applicable) may detected from history or physical examination may
benefit from psychological counseling to aid in this deci- require more detailed evaluation and treatment before
sion. The clinician should strongly recommend psycho- proceeding with insemination.
logical counseling by a qualified mental health B. A complete general physical examination should be
professional to all donor sperm recipients and their part- performed, including a pelvic examination.
ners. The assessment should include a clinical interview C. Standard preconceptional screening, testing, and
and, where appropriate, psychological testing. The clini- counseling:
cian should require psychological consultation for cou- 1. Although there are no federal requirements for test-
ples in whom factors appear to warrant further ing donor sperm recipients, the following tests are
evaluation. In cases of directed donation, the potential recommended:
impact of the relationship between the donor and recipi- a. Blood type, Rh factor, and antibody screen.
48 VOL. 99 NO. 1 / JANUARY 2013
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b. Rubella and varicella titers. Vaccination should Pretreatment HSG or laparoscopy may be indicated
be offered if the individual is not immune to ei- by the history and/or physical findings.
ther virus. G. Informed consent should be obtained from the patient
c. Neisseria gonorrhoeae and Chlamydia trachoma- (and her partner, if applicable).
tis NAT on urine or a swab obtained from the cer- VI. Donors
vix, urethral meatus, or vagina. A. Selection of donor
d. HIV-1 (AB and NAT), HIV-2 AB testing, and test- 1. The main qualities to seek in selecting a donor for
ing or screening for HIV group O antibodies TDI are an assurance of good health status and the
should be performed to address potential medi- absence of known genetic abnormalities.
cal/legal complications that could arise if the re- 2. The donor should be of legal age and, ideally, less
cipient seroconverts during or after treatment. In than 40 years of age.
addition, if the female recipient is found to be 3. Selection of donors with established fertility is desir-
HIV-infected before treatment, she should be re- able but not required.
ferred to an appropriate infectious disease spe- 4. Psychological evaluation and counseling by a quali-
cialist for counseling on issues concerning HIV fied mental health professional is strongly recom-
disease, including reproductive issues such as mended for all sperm donors. The assessment
safe sex practices for preventing HIV transmis- should include a clinical interview and, where ap-
sion to uninfected partners and treatment op- propriate, psychological testing. Psychological con-
tions to reduce the probability of transmission sultation should be required for individuals in whom
to her child. A positive HIV test of the female re- there appear to be factors that warrant further eval-
cipient should not be used as an exclusionary cri- uation. In cases of directed donation, psychological
terion for treatment with TDI as long as the evaluation and counseling are strongly recommen-
couple makes an informed decision after coun- ded for the donor and his partner (if applicable) as
seling and agrees to comply with recommended well as for the recipient female and her partner (if ap-
clinical management for the positive HIV status plicable). The potential impact of the relationship
during pregnancy. between the donor and recipient should be explored.
e. Serologic test for syphilis. The psychological assessment also should address
f. Hepatitis B surface antigen. the potential psychological risks and evaluate for ev-
g. Hepatitis B core antibody (IgG and IgM). idence of coercion (financial or emotional). It is im-
h. Hepatitis C antibody and NAT. portant to ascertain whether the donor is well
i. Cytomegalovirus (CMV) antibody (IgG and IgM). informed about the extent to which information
For women who test positive for active infection about him might be disclosed and about any plans
(positive urine or throat culture or paired serum that may exist relating to future contact.
samples demonstrating a four-fold rise in IgG anti- 5. No owner, operator, laboratory director, or em-
body and IgM antibody at least 30% of the IgG ployee of a facility performing TDI may serve as
level), attempts to conceive should be postponed a donor in that practice.
until they no longer exhibit active infection, owing 6. Neither the patient's physician nor the individual
to the risk of transmitting the infection to their fe- performing the actual insemination can be the
tus and the serious potential consequences of fetal sperm donor.
CMV infection. B. Screening and testing of donors
j. HTLV type I and II alsomay be obtained at the dis- 1. Semen testing
cretion of the clinician in the appropriate clinical a. It is suggested that more than one sample be ex-
setting. amined (each after a 2- to 5-day abstinence inter-
D. Documentation and timing of ovulation val) before proceeding with a more extensive
1. Womenwith regular cyclicmenses andmolimina are evaluation of the donor candidate.
assumed to be ovulating. When doubt exists, an in- b. The sample should be examined within 1 to 2
dex of ovulation, such as serum progesterone level, hours after ejaculation into a sterile container.
basal body temperature recordings, LH surge detec- The criteria used to judge the normality of the
tion, and ultrasound monitoring of follicular matu- sample can vary among laboratories. There are
ration, may be used to document ovulation. no uniformly accepted standards, but, in general,
Appropriate timing of the insemination procedure the minimum criteria for normal semen quality
optimizes chances for success. can be applied (1).
E. Evaluation for possible tubal or peritoneal 2. Genetic evaluation
abnormalities Genetic screening for heritable diseases should be
F. Patients who fail to conceive after 4 to 6well-timed in- performed in potential sperm donors. Testing for
seminations may be candidates for hysterosalpingog- cystic fibrosis carrier status should be performed
raphy (HSG), laparoscopy, or other appropriate tests on all donors. Other genetic testing should be per-
to detect possible causes for their failure to conceive. formed as indicated by the donor's ethnic
VOL. 99 NO. 1 / JANUARY 2013 49
ASRM PAGES
background in accordance with current recommen- the preceding 12 months. Deferral of do-
dations after obtaining a proper family history. nors is not necessary when there is evi-
Chromosomal analyses on all sperm donors are not dence of successful treatment more than
required (see Appendix A for further details regard- 12 months before.
ing genetic screening and testing) (2–4). xi. Men who have undergone body piercing
3. Medical history and/or tattooing procedureswithin the pre-
a. Donors should be healthy and give no history to ceding 12 months in which sterile proce-
suggest hereditary disease. dures were not used or it is unclear
b. A complete personal and sexual history should be whether sterile procedures were used (e.g.,
obtained to exclude as donors individuals who contaminated instruments and/or ink
might be at high risk for HIV, STIs, or other infec- were used, or shared instruments that had
tions that might be transmissible via gamete do- not been sterilized between uses were
nation. Prospective sperm donors with any of the used).
following factors should not be accepted (for xii. Men who have received a smallpox vacci-
a complete list of screening questions, see ‘‘Uni- nation (vaccinia virus) for 21 days after
form Donor Application’’ at www.sart.org): vaccination or until the scab separates
i. Men with a history of sex with another spontaneously and physical examination
man in the preceding 5 years. confirms the absence of a scab at the vac-
ii. Men who have injected drugs for non- cination site (whichever is later). The do-
medical reasons in the preceding 5 years, nor should be deferred for 2 months if
including intravenous, intramuscular, the scab was removed before spontaneous
and subcutaneous injections. separation. If the donor experienced com-
iii. Men with hemophilia or other related plications from vaccination, he should be
clotting disorders who have received deferred until 14 days after complete res-
human-derived clotting factor concen- olution of those complications. If the do-
trates in the preceding 5 years. nor became infected as a result of close
iv. Men who received clotting factors once to contact with a person recently vaccinated
treat an acute bleeding event more than for vaccinia, he may be considered eligi-
12 months ago may be eligible to donate. ble for donation if the scab spontaneously
v. Men who have had sex in exchange for separated, if 14 days have elapsed since
money or drugs in the preceding 5 years. resolution of all the vaccinia-related com-
vi. Menwho have had sex in the preceding 12 plications, or 3 months after the scab was
months with any person meeting any of otherwise removed.
the criteria described immediately above, xiii. Men who have had a medical diagnosis or
or with any person having HIV infection, suspicion of West Nile virus (WNV) infec-
including a positive or reactive test to tion (based on symptoms and/or labora-
HIV virus, hepatitis B infection, or clini- tory results or confirmed WNV viremia)
cally active (symptomatic) hepatitis C should be deferred for 120 days after the
infection. onset of symptoms or diagnosis, which-
vii. Menwhohave been exposedwithin the last ever is later.
12 months through percutaneous inocula- xiv. Men who have tested positive or reactive
tion or contact with an open wound, non- for WNV infection using an FDA-
intact skin, or mucous membrane to blood licensed or investigational WNV NAT in
that is known or suspected to be infected the preceding 120 days.
with HIV, hepatitis B, and/or hepatitis C xv. Men who have been diagnosed with var-
virus. iant CJD (vCJD) or any other form of
viii. Men who have had close contact (e.g., liv- CJD.
ing in the same household wherein shar- xvi. Men who have been diagnosed with de-
ing of kitchen and bathroom facilities mentia or any other degenerative or de-
occurs regularly) within 12 months pre- myelinating disease of the central
ceding the donation with another person nervous system or other neurologic dis-
who has hepatitis B or clinically active ease of unknown etiology. Potential do-
(symptomatic) hepatitis C infection. nors who have a diagnosis of delirium
ix. Men who have been incarcerated in lock- (e.g., delirium caused by toxic/metabolic
up, jail, or prison for more than 72 consec- diseases or recent head trauma) would
utive hours within the previous 12months. not be considered necessarily to have a di-
x. Menwho have had or have been treated for agnosis of dementia and should be evalu-
syphilis, gonorrhea, or chlamydia within ated by the medical director.
50 VOL. 99 NO. 1 / JANUARY 2013
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xvii. Men who are at increased risk for CJD. cells, tissues, or organs that have had
Donors are considered to have an in- ex vivo contact with live nonhuman ani-
creased risk for CJD if they have received mal cells, tissues, or organs) or have been
a non-synthetic dura mater transplant, in close contact with a xenotransplant
human pituitary-derived growth hor- recipient.
mone, or have one or more blood relatives xxvi. Men who have received human organ or
diagnosed with CJD. tissue transplants or treatment with hu-
xviii. Men who have a history of CJD in a blood man extracts.
relative unless: the diagnosis of CJD was 4. Physical examination
subsequently found to be in error, the a. Before acceptance, and every 6months while re-
CJD was iatrogenic, or laboratory testing maining an active donor, donors should un-
(gene sequencing) demonstrates that the dergo a complete physical examination and
donor does not have a mutation associ- should be declined when any of the following
ated with familial CJD. findings are present (see www.sart.org Male Do-
xix. Men who spent 3 months or more cumula- nor Physical Examination Form):
tively in theUnitedKingdom (U.K.) from the i. Physical evidence for risk of sexually trans-
beginning of 1980 through the end of 1996. mitted disease such as genital ulcerative le-
xx. Men who are current or former US mili- sions, herpes simplex, chancroid, or
tary members, civilian military em- urethral discharge.
ployees, or dependants of a military ii. Physical evidence for risk of, or evidence of,
member or civilian employee who resided syphilis.
at US military bases in Northern Europe iii. Physical evidence of anal intercourse in-
(Germany, Belgium, and the Netherlands) cluding perianal condylomata.
for 6 months or more cumulatively from iv. Physical evidence of non-medical percuta-
1980 through 1990, or elsewhere in Eu- neous drug use such as needle tracks; the ex-
rope (Greece, Turkey, Spain, Portugal, amination should include examination of
and Italy) for 6 months or more cumula- tattoos, which might be covering needle
tively from 1980 through 1996. tracks.
xxi. Men who spent 5 years or more cumula- v. Physical evidence of recent (within 12
tively in Europe from 1980 until present. months) tattooing, ear piercing, or body
xxii. Men who received any transfusion of piercing where sterile technique was not
blood or blood components in the United used.
Kingdom or France between 1980 and vi. Disseminated lymphadenopathy.
the present. vii. Unexplained oral thrush.
xxiii. Men or their sexual partners who were viii. Blue or purple spots consistent with Kaposi
born or lived in certain countries in Africa sarcoma.
(Cameroon, Central African Republic, ix. Unexplained jaundice, hepatomegaly, or
Chad, Congo, Equatorial Guinea, Gabon, icterus.
Niger, or Nigeria) after 1977 (risk factor x. Large scab consistent with recent history of
for HIV group O). smallpox immunization.
xxiv. Menwhohave receiveda blood transfusion xi. Eczema vaccinatum, generalized vesicular
or any medical treatment that involved rash, severely necrotic lesion (consistent
blood in the countries listed in xxiii after with vaccinia necrosum), or corneal scarring
1977 (risk factor for HIV group O). (consistent with vaccinial keratitis).
5. Laboratory testing
Note: Establishments using an HIV-1/2 antibody
There is no method to ensure completely that infec-
donor screening test that has been licensed by
tious agentswill not be transmitted byTDI.However,
the FDA and is specifically labeled in the In-
the following guidelines, combined with an ade-
tended Use section of the package insert as sen-
quate history and specific exclusion of individuals
sitive for the detection of HIV group O antibodies
at high risk for HIV and other STIs, should signifi-
may delete items VI.B.3.b.xxiii and xxiv from
cantly reduce these risks. The FDA requires that the
their screening procedures. If screening ques-
following tests be performed, using methods re-
tions VI.B.3.b.xxiii and xxiv also are asked, do-
quired for purposes of determining donor eligibility,
nor eligibility may be based on the donor test
and that negative results are documented before use
results, regardless of the answers to those two
of the donor's sperm. The list of test methods ap-
questions.
proved by the FDA for this purpose is available at
xxv. Men who have received xenotransplants
the following Web sites:
(live cells, tissues, or organs from a nonhu-
man animal source or human body fluids, http://www.fda.gov/cber/products/testkits.htm
VOL. 99 NO. 1 / JANUARY 2013 51
ASRM PAGES
http://www.fda.gov/downloads/BiologicsBlood history should be performed at 6-month
Vaccines/GuidanceComplianceRegulatoryInfor intervals.
mation/Guidances/Tissue/ucm091345.pdf m. Additional testing should be performed as dic-
tated by local or state requirements.
Clinics using donor sperm from a commercial
n. Additional testing not required by the FDA but
sperm bank should have documentation from the
recommended by the ASRM includes blood
bank that they adhere to federal and local require-
type and Rh. If the use of donor oocytes creates
ments (5).
the potential for Rh incompatibility, couples
a. HIV-1 antibody as well as NAT.
should be informed about obstetric significance
b. HIV-2 antibody.
of this condition.
c. HIV group O antibody. Establishments that do
not use an FDA-licensed test for HIV group O 6. Managing laboratory results
antibodies must evaluate donors for risk associ- a. If testing is negative, semen samples may be col-
ated with HIV group O infection with additional lected and prepared for cryopreservation.
screening questions as described in VI.B.3.b.x- b. A positive test should be verified before
xiii and xxiv. notifying the potential donor. If a test is con-
d. Hepatitis C antibody and NAT. firmed positive, the individual should be
e. Hepatitis B surface antigen. referred for appropriate counseling and
f. Hepatitis B core antibody (IgG and IgM). management.
g. Serologic test for syphilis. c. Individuals who initially test positive (except for
h. HTLV-1 and HTLV-2. treated syphilis, Neisseria gonorrhoeae, or Chla-
i. CMV (IgG and IgM). Men who test positive for mydia trachomatis as described earlier) are not
active infection (positive urine or throat culture eligible for anonymous donation.
or paired serum samples demonstrating a four- d. False-positive results for syphilis using non-
fold rise in IgG antibody and IgM antibody at treponemal assays that are confirmed to be
least 30% of the IgG level) should be excluded. negative using a treponemal-based assay are el-
Because CMV is so common, insemination with igible for donation.
semen from a CMV-seropositive man (without e. After donation, anonymous donor specimens
active infection) is permissible when the female must be quarantined for a minimum of 180
partner is also CMV seropositive. Although the days. The donor must be retested (see section
practice is not entirely without risk, because VI.B.5) after the required quarantine interval,
there are many strains of CMV and superinfec- and specimens may be released only if the re-
tion is possible, the associated risk of newborn sults of repeat testing are negative.
CMV infection is approximately 1%, and such f. Screening and testing of donors for STIs and ge-
infants appear to have no significant illness or netic risk factors may change over time as tests
other abnormality. improve and new tests become available. There-
j. Neisseria gonorrhoeae and Chlamydia trachoma- fore, samples of sperm that are cryopreserved
tis NAT on urine or a swab obtained from the and stored for periods of time may not meet ex-
urethral meatus. These tests should be repeated isting testing standards at the time they are re-
if clinically indicated. Retesting of the donor at leased for use. In such instances, every effort
6-month intervals is required as long as the do- should be made to have the donor tested in ac-
nor remains active. cordance with current standards. In situations
N.B. There are no FDA-licensed, approved or where the donor is not available or refuses
cleared tests for donor screening of these organ- such additional testing, the sample(s) may be re-
isms in an asymptomatic, low-prevalence popu- leased provided that the recipient is informed
lation. Tests using NAT technology adequately that the specimen does not meet current screen-
and appropriately reduce the risk of transmission ing and testing guidelines, is informed of what
of these relevant communicable agents. tests have not been performed, and is counseled
k. Donors found to be positive for syphilis, Neisseria regarding the clinical implications of the missing
gonorrhoeae, or Chlamydia trachomatis should information.
be treated, retested, and deferred from donation 7. Directed donation
for 12 months after documentation that treat- Directed (non-anonymous or known) donation is
ment was successful before being reconsidered. acceptable if all parties agree. Directed donors
If evidence is presented that treatment occurred must undergo the same screening and testing as
more than 12 months ago and was successful, anonymous donors. Directed donors who test posi-
no further deferral is needed as long as current tive or demonstrate a risk factor for a relevant com-
testing does not indicate an active infection. municable disease are not prohibited from use
l. Abbreviated donor screening documenting no according to current FDA rules, provided that the
change in the donor's medical and/or social tissue is labeled to indicate any associated increased
52 VOL. 99 NO. 1 / JANUARY 2013
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risks and that physicians using samples are aware of lated subgroup or if the specimens are distributed
the status of the results. Although the FDA does not over a wide geographic area.
require informing the recipients of the test results, in 4. Consent
the opinion of the ASRM the recipients must be in- It is essential for the donor to sign a consent form,
formed and counseled appropriately before use of which should include a firm denial of having any rec-
the samples. Directed donor specimens also are ex- ognized risk factors for STIs and genetic diseases. It is
empt from quarantine under the current FDA guide- recommended that the donor acknowledge in the con-
lines, which require only retesting as described sent form his responsibility to notify the donor pro-
earlier (see section VI.B.5) within 7 days before do- gramof any changes in his health or risk factor status.
nation. However, in the opinion of the ASRM, di- 5. Record keeping
rected donor specimens should be treated in the The FDA requires that records pertaining to each do-
same manner as anonymous donor specimens; re- nor (screening and test results) be maintained for at
sults of testing that would exclude an anonymous least 10 years. However, in the opinion of the ASRM,
donor also should exclude a directed donor, and di- a permanent record of each donor's initial selection
rected donor specimens should be quarantined and process and subsequent follow-up evaluations
released in the same manner required for anony- should be maintained. Ideally, the clinical outcome
mous donor specimens (see sections VI.B.1–6). of each insemination cycle should be recorded as
8. Use of fresh semen well as a mechanism for reporting any adverse out-
In the opinion of the ASRM, the use of fresh semen comes including heritable diseases identified pre-
can be justified only for sexually intimate couples. It conceptually or post natally. In the event that
is possible for HIV and other infectious organisms to a previously unidentified heritable disease is en-
be transmitted by fresh donor semen before the do- countered in a child produced from anonymous do-
nor has become seropositive. Consequently, the po- nation, the donor as well as the recipient of the
tential for transmission of infections by fresh semen donated sperm should be tested and further release
cannot be eliminated. The ASRM recommends that of samples from the donor should be prohibited. If
all directed donor specimens be frozen and quaran- the donor is found to be the carrier for the heritable
tined for a minimum of 180 days, with the donor disease, all recipients of that donated sperm as well
then retested as described above (see section as the clinics performing the procedures should be
VI.B.5) and demonstrated seronegative before the notified and counseled. A mechanism must exist to
specimen is released. maintain records on the donor as a future medical
C. Management of donors resource for any offspring produced.
1. Monitoring health status 6. Protection of confidentiality
The single most important method for reducing the Individuals participating in donor programs should
risk of transmitting infectious agents to women dur- be assured that their confidentiality will be protected
ing insemination is to screen carefully and test the insofar as federal and local statutes permit. Medical
potential donors and to develop an ongoing proce- records detailing the donation should be maintained
dure for monitoring their health status. as stipulated by federal and local requirements.
2. Payment to donors VII. Choosing donor characteristics
Payment to donors varies from area to area but There are several methods for matching the male partner
should not be such that the monetary incentive is with the donor. The couple should be encouraged to list
the primary motivation for donating sperm. How- the characteristics that they desire in a prospective do-
ever, the donor may be compensated for his time nor, including race and/or ethnic group, height, body
and expenses. build, complexion, eye color, and hair color and texture.
3. Limitations to donor use Consideration should be given to blood type and Rh fac-
Institutions, clinics, and sperm banks should main- tor, particularly for Rh-negative recipients. If the use of
tain sufficient records to allow a limit to be set for donor sperm creates the potential for Rh incompatibility,
the number of pregnancies for which a given donor recipients should be informed of the obstetric implica-
is responsible. It is difficult to provide a precise num- tions of the condition.
ber of times that a given donor can be used because
one must take into consideration the population
GUIDELINES FOR OOCYTE DONATION
base from which the donor is selected and the geo-
graphic area that may be served by a given donor. I. Introduction
It has been suggested that in a population of Oocyte donation requires ovarian stimulation with moni-
800,000, limiting a single donor to no more than toring and oocyte retrieval, involving significant inconve-
25 births would avoid any significant increased nience, discomfort, and risks for the donor.
risk of inadvertent consanguineous conception. II. Indications for use of donor oocytes
This suggestion may require modification if the pop- A. Women with hypergonadotropic hypogonadism.
ulation using donor insemination represents an iso- B. Women of advanced reproductive age.
VOL. 99 NO. 1 / JANUARY 2013 53
ASRM PAGES
C. Women who have diminished ovarian reserve. HIV test of the female recipient should not be
D. Women who are known to be affected by or known to used as an exclusionary criterion for treatment,
be the carrier of a significant genetic defect or who provided that the couple makes an informed de-
have a family history of a condition for which carrier cision after counseling and agrees to comply with
status cannot be determined. recommended clinical management for the posi-
E. Women with poor oocyte and/or embryo quality or tive HIV state.
multiple previous failed attempts to conceive via ART. d. Serologic test for syphilis.
III. Psychological consultation for oocyte donor recipients e. Hepatitis B surface antigen.
The decision to proceed with donated oocytes is complex, f. Hepatitis B core antibody (IgG and IgM).
and patients and their partners (if applicable) may benefit g. Hepatitis C antibody and NAT.
from psychological counseling to aid in this decision. The h. Neisseria gonorrhoeae and Chlamydia trachoma-
clinician should strongly recommend psychological tis NAT on urine or a swab obtained from the cer-
counseling by a qualified mental health professional to vix, urethral meatus, or vagina.
all donor oocyte recipients and their partners. The assess- V. Evaluation of the partner of the oocyte recipient
ment should include a clinical interview and, where ap- A. Laboratory tests. Although there are no federal re-
propriate, psychological testing. The clinician should quirements for testing the partner of the oocyte recip-
require psychological consultation for couples in whom ient, the following tests are recommended:
there appear to be factors that warrant further evaluation. 1. Semen analysis for male partners.
In cases of directed donation, the potential impact of the 2. Blood type and Rh factor.
relationship between the donor and recipient should be 3. Serologic test for syphilis.
explored, as well as any plans that may exist relating to 4. Hepatitis B surface antigen.
disclosure and future contact. 5. Hepatitis B core antibody (IgG and IgM).
IV. Evaluation of the oocyte recipient 6. Hepatitis C antibody and NAT.
A. Medical and reproductive history 7. HIV-1 (AB and NAT), HIV-2 AB testing and screen-
1. Routine medical and reproductive histories should ing, or testing for HIV group O antibodies. HIV test-
be obtained according to the standards that are ap- ing should be performed to address potential
plied to women anticipating pregnancy. Reproduc- medical/legal complications that could arise if the
tive abnormalities detected from history or physical recipient seroconverts during or after treatment. In
examination may require more detailed evaluation addition, if the partner is found to be HIV infected
and treatment before donor oocytes are used. before treatment, he should be referred to an appro-
B. A complete general physical examination should be priate infectious disease specialist for counseling on
performed, including a pelvic examination. issues concerning HIV disease, including reproduc-
C. Assessment of the uterine cavity tive issues such as safe sex practices for preventing
1. HSG, saline infusion ultrasonography, or another HIV transmission to uninfected partners. Counseling
suitable procedure should be performed to detect should be documented in the medical record. A pos-
any significant uterine abnormality. itive HIV test of the partner should not be used as an
D. Standard preconceptional testing and counseling exclusionary criterion for treatment.
1. Although there are no federal requirements for test- 8. Appropriate genetic screening and testing based on
ing oocyte recipients, the following tests are history, in accordance with ethnic background and
recommended: current recommendations (see Appendix A) (2–4).
a. Blood type, Rh factor, and antibody screen. VI. Donors
b. Rubella and varicella titers. Recipients should be A. Selection of donors
offered immunization if not immune. 1. Oocyte donation may be undertaken with known
c. HIV-1 (AB and NAT), HIV-2 AB testing and or anonymous donors depending on the clinical
screening or testing for HIV group O antibodies. circumstances.
HIV testing should be performed to address po- 2. Psychological evaluation and counseling by a qual-
tential medical/legal complications that could ified mental health professional is strongly recom-
arise if the recipient seroconverts during or after mended for the oocyte donor and her partner (if
treatment. In addition, if the female recipient is applicable). The assessment should include a clini-
found to be HIV infected before treatment, she cal interview and, where appropriate, psychologi-
should be referred to an appropriate infectious cal testing. Psychological consultation should be
disease specialist for counseling on issues con- required for individuals in whom there appear to
cerning HIV disease, including reproductive is- be factors that warrant further evaluation. In cir-
sues such as safe sex practices for preventing cumstances involving known donors, psychologi-
HIV transmission to uninfected partners and cal evaluation and counseling is strongly
treatment options to reduce the probability of recommended for the donor and her partner, if ap-
transmission to her child; counseling should be plicable, as well as for the recipient and her partner,
documented in the medical record. A positive if applicable. The potential impact of the
54 VOL. 99 NO. 1 / JANUARY 2013
Fertility and Sterility®
relationship between the donor and recipient b. Women with hemophilia or other related clotting
should be explored. The psychological assessment disorders who have received human-derived
also should address the potential psychological clotting factor concentrates in the preceding 5
risks and evaluate for evidence of coercion (finan- years.
cial or emotional). It is important to ascertain i. Women who received clotting factors to treat
whether the donor is well informed about the ex- an acute bleeding event more than 12 months
tent to which information about her may be dis- prior to planned donation may be eligible to
closed and about any plans that may exist donate.
relating to future contact. c. Women who have had sex with a man who has
3. Oocyte donors should be of legal age and prefer- had sex with another man in the past 5 years.
ably between the ages of 21 and 34 years. d. Women who have had sex in exchange for
4. Donors less than 21 years of age should have psy- money or drugs in the preceding 5 years.
chological evaluation by a qualified mental health e. Women who have had sex in the preceding 12
professional, and the decision to proceed with such months with any person meeting any of the crite-
a donor shouldbedeterminedonan individual basis. ria described immediately above, or with any per-
5. If a prospective donor is over 34 years of age, the son having HIV infection including a positive or
age of the donor should be revealed to the recipient reactive test to HIV virus, hepatitis B infection, or
as part of the informed consent discussion con- clinically active (symptomatic) hepatitis C
cerning cytogenetic risks and the effect of donor infection.
age on pregnancy rates. f. Womenwho have been exposed within the last 12
6. Proven fertility in the donor is desirable but not months, through percutaneous inoculation or
required. contact with an open wound, non-intact skin,
7. The donor should undergo appropriate genetic or mucous membrane, to blood that is known or
evaluation based on history, in accordance with suspected to be infected with HIV, hepatitis B,
ethnic background and current guidelines. Cystic and/or hepatitis C virus.
fibrosis testing should be performed on all donors. g. Women who have had close contact (e.g., living
Consideration should be given to fragile X testing in the same household wherein sharing of
on donors, but is not required (see Appendix A) kitchen and bathroom facilities occurs regularly)
(2–4). within 12 months preceding the donation with
8. Sharing of oocytes from an assisted reproduction another person who has hepatitis B or clinically
cycle: If sharing of oocytes is contemplated, in- active (symptomatic) hepatitis C infection.
formed consent must be obtained before the start h. Women who have been incarcerated in lock-up,
of the cycle of retrieval. The conditions governing jail, or prison for more than 72 consecutive hours
the sharing of oocytes should be specified in ad- within the previous 12 months.
vance, be included in the informed consent, and i. Women who have had or have been treated for
comply with existing ASRM Ethics Committee syphilis, gonorrhea, or chlamydia within the pre-
guidelines (6). ceding 12 months. Deferral of donors is not nec-
9. No owner, operator, laboratory director, or em- essary if evidence is presented that treatment
ployee of a facility screening for or performing oo- occurred more than 12 months ago and was
cyte donation may serve as a donor in that practice. successful.
10. If an agency is used to recruit oocyte donors, no in- j. Women who have undergone body piercing and/
dividual who has a financial interest in that agency or tattooing procedures within the preceding 12
may be used as an oocyte donor. months in which sterile procedures were not
B. Screening and testing of oocyte donors used or it is unclear whether sterile procedures
1. Donors should be healthy and give no history to were used (e.g., contaminated instruments and/
suggest hereditary disease. or ink were used or shared instruments that had
2. A complete personal and sexual history should be not been sterilized between uses were used).
obtained to exclude as donors individuals who k. Women who have received a smallpox vaccina-
might be at high risk for HIV, STIs, or other infec- tion (vaccinia virus) for 21 days after
tions that might be transmissible via gamete vaccination or until the scab separates spontane-
donation. Prospective oocyte donors with any of ously and physical examination confirms the ab-
the following factors should not be accepted (for sence of a scab at the vaccination site (whichever
a complete list of screening questions, see ‘‘Uniform is later). The donor should be deferred for 2
Donor Application’’ at www.sart.org): months if the scab was removed before spontane-
a. Womenwho have injected drugs for non-medical ous separation. If the donor experienced compli-
reasons in the preceding 5 years, including intra- cations from vaccination, she should be deferred
venous, intramuscular, and subcutaneous until 14 days after complete resolution of those
injections. complications. If the donor became infected as
VOL. 99 NO. 1 / JANUARY 2013 55
ASRM PAGES
a result of close contact with a person recently rial Guinea, Gabon, Niger, or Nigeria) after 1977
vaccinated for vaccinia, she may be considered (risk factor for HIV group O).
eligible for donation if the scab spontaneously w. Womenwho have received a blood transfusion or
separated, if 14 days have elapsed since resolu- any medical treatment that involved blood in the
tion of all the vaccinia-related complications, or countries listed above after 1977 (risk factor for
3 months after the scab was otherwise removed. HIV group O).
l. Women who have had a medical diagnosis or sus-
Note: Establishments using an HIV-1/2 antibody
picion of WNV infection (based on symptoms
donor screening test that has been licensed by the
and/or laboratory results or confirmedWNV vire-
FDA and is specifically labeled in the Intended Use
mia) should be deferred for 120 days after the on-
Section of the package insert as sensitive for the de-
set of symptoms or diagnosis, whichever is later.
tection of HIV group O antibodies may delete items
m. Women who have tested positive or reactive for
VI.B.2.v and VI.B.2.w from their screening proce-
WNV infection using an FDA-licensed or investi-
dures. If screening questions VI.B.2.v and VI.B.2.w
gational WNV NAT donor-screening test in the
also are asked, donor eligibility may be based on
preceding 120 days.
the results of the donor test results regardless of
n. Women who have been diagnosed with vCJD or
the answers to those two questions.
any other form of CJD.
x. Women who have received xenotransplants (live
o. Women who have been diagnosed with dementia
cells, tissues, or organs from a nonhuman animal
or any other degenerative or demyelinating dis-
source or human body fluids, cells, tissues, or or-
ease of the central nervous system or other neuro-
gans thathavehadexvivocontactwith livenonhu-
logic disease of unknown etiology. Potential
man animal cells, tissues, or organs) or have been in
donors who have a diagnosis of delirium (e.g., de-
close contact with a xenotransplant recipient.
lirium caused by toxic/metabolic diseases or re-
y. Womenwho have received human organ or tissue
cent head trauma) would not be considered
transplants or treatment with human extracts.
necessarily to have a diagnosis of dementia and
3. Before acceptance, and every 6monthswhile remain-
should be evaluated by the medical director.
ing an active donor, donors should undergo a com-
p. Women who are at increased risk for CJD. Donors
plete physical examination and should be declined
are considered to have an increased risk for CJD if
whenanyof the followingfindings are present (see fe-
they have received a non-synthetic dura mater
male donor physical exam at www.sart.org):
transplant, human pituitary-derived growth hor-
a. Physical evidence for risk of sexually transmitted
mone, or have one or more blood relatives diag-
disease such as genital ulcerative lesions, herpes
nosed with CJD.
simplex, chancroid, and urethral discharge.
q. Women who have a history of CJD in a blood rela-
b. Physical evidence for risk of or evidence of
tive unless the diagnosis of CJD was subsequently
syphilis.
found to be in error, the CJDwas iatrogenic, or lab-
c. Physical evidence of anal intercourse including
oratory testing (gene sequencing) demonstrates
perianal condylomata.
that the donor does not have a mutation associated
d. Physical evidence of non-medical percutaneous
with familial CJD.
drug use such as needle tracks; the examination
r. Women who spent 3 months or more cumula-
should include examination of tattoos, which
tively in the United Kingdom from the beginning
might be covering needle tracks.
of 1980 through the end of 1996.
e. Physical evidence of recent (within 12 months)
s. Women who are current or former US military
tattooing, ear piercing, or body piercing where
members, civilian military employees, or depen-
sterile procedure was not used.
dants of a military member or civilian employee
f. Disseminated lymphadenopathy.
who resided at US military bases in Northern Eu-
g. Unexplained oral thrush.
rope (Germany, Belgium, and the Netherlands) for
h. Blue or purple spots consistent with Kaposi
6 months or more cumulatively from 1980
sarcoma.
through 1990, or elsewhere in Europe (Greece,
i. Unexplained jaundice, hepatomegaly, or icterus.
Turkey, Spain, Portugal, and Italy) for 6 months
j. Large scab consistent with recent history of
or more cumulatively from 1980 through 1996.
smallpox immunization.
t. Women who spent 5 years or more cumulatively
k. Eczema vaccinatum, generalized vesicular rash,
in Europe from 1980 until present.
severely necrotic lesion (consistent with vaccinia
u. Women who received any transfusion of blood or
necrosum), or corneal scarring (consistent with
blood components in the United Kingdom or
vaccinial keratitis).
France between 1980 and the present.
4. Laboratory testing
v. Women or their sexual partners whowere born or There is no method to ensure completely that infec-
lived in certain countries in Africa (Cameroon, tious agents will not be transmitted via oocyte dona-
Central African Republic, Chad, Congo, Equato- tion. However, the following guidelines, combined
56 VOL. 99 NO. 1 / JANUARY 2013