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    Recommendations for practices_utilizing_gestational_carriers_nonmembers Recommendations for practices_utilizing_gestational_carriers_nonmembers Document Transcript

    • PRACTICE COMMITTEERecommendations for practicesutilizing gestational carriers: anASRM Practice Committee guidelineThe Practice Committee of the American Society for Reproductive Medicine and the Practice Committee for the Society forAssisted Reproductive TechnologyAmerican Society for Reproductive Medicine; and Society for Assisted Reproductive Technology, Birmingham, AlabamaThis document provides the latest recommendations for evaluation of gestational carriers and intended parents. It incorporates recent information fromthe US Centers for Disease Control and Prevention, the US Food and Drug Administration, and the American Association of Tissue Banks, with which allprograms offering gestational carrier services must be thoroughly familiar. (Fertil SterilÒ 2012;-:-–-. Ó2012 by American Society for ReproductiveMedicine.)Earn CME credit for this document at www.asrm.org/eLearnSTATEMENT OF PURPOSE factors that place an individual at than the FDA, and clinics should beThe following recommendations are in- a higher risk for a given disease, such aware of minimum screening and testingtended to provide guidance for when it as human immunodeficiency virus requirements for their state.is appropriate to consider using a gesta- (HIV) and transmissible spongiform en- cephalopathy (TSE), or Creutzfeldt- 1. Indications for the use of a gesta-tional carrier, provide guidelines for tional carrier:screening and testing of genetic parents Jakob disease (CJD). ‘‘Testing’’ refers to specific laboratory studies such as a. Gestational carriers may be usedand gestational carriers to reduce the when a true medical condition pre-possibility of complications, and to ad- serologic tests. The distinction between screening and testing is consistent cludes the intended parent fromdress the complex medical and psycho- carrying a pregnancy or wouldlogical issues that confront the within the document. The term ‘‘ineligi- ble’’ does not mean excluded, but eligi- pose a significant risk of death orgestational carrier and the intended harm to the woman or the fetus.parents, as well as the children. These ble with appropriate informed consent. These guidelines for the screening The indication must be clearlyguidelines incorporate recent informa- documented in the patients medi-tion about optimal screening and test- and testing of gestational carriers and the genetic parents apply to individuals cal record. Examples of such med-ing for sexually transmitted infections ical indications would include:(STI) and psychological assessments. in the United States. Because the preva- lence of STIs and genetic diseases may i. Absence of uterus (congen-The current document represents an ef- ital or acquired)fort to make the screening guidelines vary in other geographic areas, these guidelines may not be appropriate for ii. Significant uterine anomalyfor individuals involved in third-party (e.g., irreparable Ashermanreproduction using a gestational carrier other countries or individuals who come to the United States from other syndrome; unicornuatemore consistent and incorporates re- uterus associated with re-cent information from the US Centers countries. Whereas the FDA does not re- quire screening or testing of the gesta- current pregnancy loss)for Disease Control and Prevention iii. Absolute medical contrain-(CDC), US Food and Drug Administra- tional carrier, the American Society for Reproductive Medicine (ASRM) recom- dication to pregnancy (e.g.,tion (FDA), and American Association pulmonary hypertension)of Tissue Banks (AATB). mends testing these individuals as de- scribed. Other areas where the ASRM iv. Serious medical condition These guidelines use terminology that could be exacerbatedfrom the federal agencies in addition recommendations may be more stringent than the FDA minimum requirements are by pregnancy or cause sig-to the AATB. In that context, the term nificant risk to the fetus‘‘screening’’ refers to specific historical noted in the text. Additionally, state re- quirements may be more restrictive v. Biologic inability to con- ceive or bear a child, suchReceived March 8, 2012; accepted March 9, 2012. as single male or homo-Reprint requests: American Society for Reproductive Medicine, Education, 1209 Montgomery High- way, Birmingham, AL 35216 (E-mail: asrm@asrm.org). sexual male couple. b. Gestational carriers may beFertility and Sterility® Vol. -, No. -, - 2012 0015-0282/$36.00 considered when an unidentifiedCopyright ©2012 American Society for Reproductive Medicine, Published by Elsevier Inc.doi:10.1016/j.fertnstert.2012.03.011 endometrial factor exists, such asVOL. - NO. - / - 2012 1 SCO 5.1.0 DTD Š FNS27338_proof Š 9 April 2012 Š 3:46 pm Š ce JS
    • PRACTICE COMMITTEE for patients with multiple unexplained previous IVF Technology [SART] physical examination forms, failures despite transfer of good-quality embryos. www.sart.org). When any of the following is c. No owner, operator, laboratory director, or employee of present, the genetic parents are considered inel- the practice may serve as a carrier or intended parent in igible (see above). that practice. 1. Physical evidence for risk of sexually trans-2. Intended parents: mitted disease, such as genital ulcerative le- a. Psychosocial education sions, herpes simplex, chancroid, and The decision to use a gestational carrier is complex, and urethral discharge patients and their partners (if applicable) may benefit 2. Physical evidence of risk for syphilis or evi- from psychosocial education to aid in this decision. dence of syphilis The physician should strongly recommend psychosocial 3. Physical evidence of anal intercourse in the education and counseling by a qualified mental health male partner, including perianal condylomata professional to all intended parents. The assessment 4. Physical evidence of nonmedical percutane- should include a clinical interview and, where appropri- ous drug use, such as needle tracks; the ex- ate, psychological testing. Psychological test data should amination should include examination of be handled in accordance with American Psychological tattoos, which might obscure needle tracks Association Ethical Standards (1). The physician should 5. Physical evidence of recent tattooing, ear require psychological consultation for couples in piercing, or body piercing (within the past 12 whom factors appear to warrant further evaluation. months) where sterile technique was not used The potential impact of the relationship between the in- 6. Disseminated lymphadenopathy tended parent and carrier should be explored, as should 7. Unexplained oral thrush any plans that may exist relating to disclosure and future 8. Blue or purple spots consistent with Kaposi contact (see section titled Psychosocial consultation sarcoma for gestational carriers and intended parents 4.a.). 9. Unexplained jaundice, hepatomegaly, or b. Screening and testing of genetic parents icterus i. Genetic parents should undergo appropriate ge- 10. Large scab consistent with recent history of netic evaluation based on history, in accordance smallpox immunization with ethnic background and current guidelines. 11. Eczema vaccinatum, generalized vesicular Cystic fibrosis testing should be performed on rash, severely necrotic lesion (consistent all genetic parents. with vaccinia necrosum), or corneal scarring ii. The genetic parents should undergo a complete (consistent with vaccinial keratitis) medical evaluation including a thorough history v. Laboratory testing and physical examination to ensure that they There is no method that completely ensures that are healthy enough to proceed with procedures in- infectious agents will not be transmitted to the volving assisted reproduction technologies (ART). gestational carrier. However, the following iii. Genetic parents must be screened in the same guidelines, combined with an adequate medical manner as gamete donors (2–4). Prospective history and specific exclusion of individuals at genetic parents with any identified risk factors high risk for HIV and other STIs should signifi- based on screening questionnaires are cantly reduce these risks. The FDA requires that considered ineligible according to guidelines the following tests be performed within 30 days issued by the FDA. According to current FDA of oocyte retrieval and within 7 days of sperm guidelines, embryos created by such individuals collection, using methods approved specifically can still be transferred into a gestational carrier for purposes of determining donor eligibility, provided that the tissue is labeled to indicate and that negative results be documented before any associated increased risks and that use of the genetic parents gametes. Tests using physicians transferring the embryos are aware of nucleic acid testing (NAT) technology to target the status of the results. Although the FDA does sequences located in specific genes adequately not require that the gestational carrier be and appropriately reduce the risk of transmission informed of the results of the screening, ASRM of these relevant communicable agents. The list recommends that embryos created using of test methods approved by the FDA for the gametes from individuals considered ineligible purpose of donor screening is available at the should only be transferred to a gestational following Web sites: http://www.fda.gov/cber/ carrier who is adequately informed and products/testkits.htm, http://www.fda.gov/cber/ counseled regarding the associated potential risks. tissue/prod.htm iv. Before acceptance, and within 6 months of cre- 1. HIV-1 antibody and NAT ating the embryos to be transferred, the genetic 2. HIV-2 antibody parents must undergo a complete physical ex- 3. HIV group O antibody. Establishments that amination (Society for Assisted Reproductive do not use an FDA-licensed test for HIV2 VOL. - NO. - / - 2012 SCO 5.1.0 DTD Š FNS27338_proof Š 9 April 2012 Š 3:46 pm Š ce JS
    • Fertility and Sterility® group O antibodies must evaluate the genetic serum samples demonstrating a fourfold rise parents for risk associated with HIV group O in IgG antibody and IgM antibody at least infection with additional screening ques- 30% of the IgG level) should be excluded until tions (see ‘‘risk factor questionnaire for do- signs of active infection are no longer present. nors,’’ available at www.sart.org) There are many strains of CMV, and superin- 4. Hepatitis C antibody and NAT fection in the gestational carrier is possible 5. Hepatitis B surface antigen even if she is CMV IgG positive. The risk of 6. Hepatitis B core antibody (IgG and IgM) CMV transmission and newborn CMV infec- 7. Serologic test for syphilis tion from an embryo transfer is extremely 8. Additional testing for the female genetic par- low, and such infants appear to have no sig- ent must include: nificant illness or other abnormality. a. Neisseria gonorrhea and Chlamydia tracho- 5. Individuals who initially test positive (except matis NAT on urine or a swab obtained from for treated syphilis, Neisseria gonorrhea, the cervix, urethral meatus, or vagina. Be- Chlamydia trachomatis, or CMV as described cause there are no tests licensed, approved, above) are considered ineligible. According or cleared by the FDA for screening donors to current FDA guidelines, embryos created for Neisseria gonorrhea and Chlamydia tra- by such individuals can still be transferred chomatis, the laboratory must use an FDA- into a gestational carrier provided that the licensed, -approved, or -cleared test labeled tissue is labeled to indicate any associated in- for the detection of these organisms in an creased risks and that physicians transferring asymptomatic, low-prevalence population the embryos are aware of the status of the 9. Additional testing for the male genetic parent results. Although the FDA does not require must include: that recipients be informed of the test results, a. Neisseria gonorrhea and Chlamydia tra- in the opinion of the ASRM, recipients must chomatis testing using a NAT on urine or be informed and counseled appropriately be- a swab obtained from the urethral meatus fore such embryos can be transferred into using an FDA-licensed, -approved, or a gestational carrier. -cleared test labeled for the detection of vii. Quarantining of embryos these organisms in an asymptomatic, All potential gestational carriers should be of- low-prevalence population fered the option of cryopreserving and quaran- b. HTLV-1 and HTLV-2 tining embryos derived from the genetic parents c. Cytomegalovirus (CMV) (IgG and IgM) for 180 days, with release of embryos only after 10. ASRM recommends testing the genetic par- the genetic parents have been retested with con- ents blood type and Rh factor. If there is firmed negative results (see section on labora- the potential for Rh incompatibility, couples tory testing for intended parents, 2.v.1-9.). should be informed about the obstetric sig- However, couples also should be informed that nificance of this condition. embryo cryopreservation may significantly re- vi. Managing laboratory results duce implantation rates. The gestational carrier 1. A positive test should be confirmed before noti- should be counseled appropriately in the event fying the potential genetic parent. If a test is con- of seroconversion of a genetic parent after cryo- firmed positive, the individual should be referred preservation of the embryos. for appropriate counseling and management. viii. Record keeping 2. Individuals with false-positive test results for The FDA requires that records pertaining to syphilis using non-treponemal assays that each genetic parent (screening and test results) are confirmed to be negative using a trepone- be maintained for at least 10 years. However, in mal-based assay are considered eligible. the opinion of the ASRM, a permanent record 3. Individuals with positive tests for syphilis, of each intended parents initial screening, test- Neisseria gonorrhea, or Chlamydia trachomatis ing, and subsequent follow-up evaluations should be treated, retested, and deferred from should be maintained. To the extent possible, creating embryos for use in a gestational carrier the clinical outcome for each cycle should be for 12 months after documentation that treat- recorded. A mechanism must exist to maintain ment was successful before being reconsidered. such records as a future medical resource for If evidence is presented documenting success- any offspring produced. ful treatment more than 12 months prior, no 1. Protection of confidentiality: Individuals par- further deferral is needed as long as current ticipating in gestational carrier programs testing does not indicate an active infection. should be assured that their confidentiality 4. Men who test positive for active CMV infec- and medical information will be protected in- tion (positive urine or throat culture or paired sofar as federal and local statutes permit.VOL. - NO. - / - 2012 3 SCO 5.1.0 DTD Š FNS27338_proof Š 9 April 2012 Š 3:46 pm Š ce JS
    • PRACTICE COMMITTEE Medical records detailing the eligibility of the might be transmissible to the fetus. Although intended parents should be maintained as the FDA does not require screening or testing of stipulated by federal and local requirements. gestational carriers for possible transmissible in- ix. Legal issues and informed consent fectious diseases to the fetus, ASRM recommends 1. The genetic parents should be counseled testing of all gestational carriers and their regarding the risks and adverse effects of partners within 30 days before embryo transfer ovarian stimulation and retrieval, with such to protect the health and interests of all parties counseling documented in the patients per- involved (see www.sart.org for screening manent medical records. questionnaire). 2. Intended parents must have ongoing legal ii. Before acceptance, the potential gestational car- counsel by an appropriately qualified legal rier should undergo a complete medical evalua- practitioner who is experienced with third- tion by a qualified medical professional and be party reproduction and licensed to practice cleared for pregnancy before being considered. in the relevant state or states, or in the event iii. The carrier should not be used when any of the of an international arrangement, in addition following findings are present: to any relevant states, the intended parent(s) 1. Physical evidence for risk of sexually trans- home country. mitted disease, such as genital ulcerative3. Gestational carriers lesions, herpes simplex, chancroid, and ure- a. Selection and evaluation of gestational carriers: thral discharge i. Psychosocial evaluation and counseling by 2. Physical evidence of risk for syphilis or a qualified mental health professional is strongly evidence of syphilis recommended for all potential gestational carriers 3. Physical evidence of nonmedical percutane- and their partners. The assessment should include ous drug use, such as needle tracks; the ex- a clinical interview and, where appropriate, psy- amination should include examination of chological testing. Psychological test data should tattoos, which might obscure needle tracks be handled in accordance with American Psycho- 4. Physical evidence of recent tattooing, ear logical Association Ethical Standards (1). The piercing, or body piercing (within the past physician should require psychological consulta- 12 months) where sterile technique was not tion for couples in whom factors appear to war- used rant further evaluation. The potential impact of 5. Disseminated lymphadenopathy the relationship between the gestational carrier 6. Unexplained oral thrush and intended parent should be explored, as well 7. Blue or purple spots consistent with Kaposi as any plans that may exist relating to disclosure sarcoma and future contact (see section on laboratory test- 8. Unexplained jaundice, hepatomegaly, or ing for intended parents, 4.a.). icterus 1. The psychosocial evaluation and counseling 9. Large scab consistent with recent history of should consider the impact of the pregnancy smallpox immunization on family and community dynamics. 10. Eczema vaccinatum, generalized vesicular 2. Carriers must be of legal age, and preferably rash, severely necrotic lesion (consistent between the ages of 21 and 45 years. Certain with vaccinia necrosum), or corneal scarring situations may dictate the use of a carrier older (consistent with vaccinial keratitis) than 45 years of age, but all parties involved iv. Laboratory testing must be informed about the potential risks of There is no method to completely ensure that the pregnancy with advancing maternal age. carrier will not have infectious agents that could 3. Ideally, the carrier should have had at least be transmitted to the fetus. However, the follow- one, term, uncomplicated pregnancy before ing guidelines, combined with an adequate med- being considered as a gestational carrier for ical history and specific exclusion of individuals another couple. at high risk for HIV and other STIs, should dra- 4. Ideally, the carrier should not have had more matically reduce these risks. The ASRM recom- than a total of five previous deliveries or three mends the following tests be performed on the deliveries via cesarean section. carrier and her partner and that negative results 5. Ideally, the carrier should have a stable family be documented before use of the gestational environment with adequate support to help carrier. her cope with the added stress of pregnancy. 1. HIV-1 antibody as well as NAT b. Screening and testing of a gestational carrier 2. HIV-2 antibody i. A complete personal and sexual history should be 3. HIV group O antibody obtained to identify individuals who might be at 4. Hepatitis C antibody and NAT high risk for HIV, STIs, or other infections that 5. Hepatitis B surface antigen4 VOL. - NO. - / - 2012 SCO 5.1.0 DTD Š FNS27338_proof Š 9 April 2012 Š 3:46 pm Š ce JS
    • Fertility and Sterility® 6. Hepatitis B core antibody (IgG and IgM) mal-based assay are eligible to be used as 7. Serologic test for syphilis gestational carriers. 8. CMV (IgG and IgM) 5. Women or their partners who test positive for 9. For women: active infection with CMV (positive urine or a. Neisseria gonorrhea and Chlamydia tra- throat culture or paired serum samples demon- chomatis testing using cervical cultures or strating a four-fold rise in IgG antibody and IgM NAT on urine or a swab obtained from the antibody at least 30% of the IgG level) should be cervix, vagina, or urethral meatus using excluded from serving as a carrier until signs of an FDA-licensed, -approved, or -cleared active infection are no longer present. test labeled for the detection of these vi. Legal issues and informed consent organisms in an asymptomatic, low- 1. Gestational carriers and their partners/spouse prevalence population should be advised explicitly of the risks of the b. Blood type and Rh factor. If there is the po- procedures and medications as well as poten- tential for Rh incompatibility, couples tial complications of pregnancy, including the should be informed about the obstetric sig- possibility of prolonged bed rest or hospitali- nificance of this condition. zation. This counseling should be documented c. Papanicolaou smear in the patients permanent medical record. d. Mammogram according to American Col- 2. Gestational carriers must have ongoing inde- lege of Obstetricians and Gynecologists pendent legal representation by an appropri- guidelines ately qualified legal practitioner who is e. Titers for varicella and rubella experienced with gestational carrier contracts f. Urine drug screen and who is licensed in the relevant state or 10. Additional testing for the male partner states, or in the event of an international ar- should include: rangement, in addition to any relevant states, a. Neisseria gonorrhea and Chlamydia tracho- the intended parent(s) home country. matis testing using a NAT on urine or a swab 3. Special consideration should be given to obtained from the urethral meatus using transferring a single embryo in an effort to an FDA-licensed, -approved, or -cleared limit the risks of multiple pregnancy for the test labeled for the detection of these organ- carrier. After appropriate counseling and isms in an asymptomatic, low-prevalence agreement by all parties, additional embryos population may be transferred based on the age of the ge- b. HTLV-1 and HTLV-2 netic parent, in an effort to improve the prob- c. CMV (IgG and IgM) ability of pregnancy. v. Managing laboratory results 4. Protection of confidentiality: Individuals par- 1. A positive test should be confirmed before no- ticipating in gestational carrier programs tifying the individual. If a test is confirmed should be assured that their confidentiality positive, the individual should be referred for and medical/psychological information will appropriate counseling and management. be protected insofar as federal and local stat- 2. Individuals who test positive for HIV-1, HIV-2, utes permit. HIV group O antibody, hepatitis B, or hepatitis 5. Issues regarding screening and testing of the C should generally not be allowed to serve as fetus during pregnancy should be discussed gestational carriers. Exceptions to this recom- and the discussion documented in the medical mendation require careful counseling, in- record or legal contract between the carrier formed consent, and documentation of risks and the intended parents. Contingency plans in the medical records. for management of specific complications 3. Individuals found to be positive for syphilis, (i.e., abnormal genetic testing of the fetus, Neisseria gonorrhea, or Chlamydia trachoma- birth defects, etc.) should be discussed and tis should be treated, retested, and deferred agreed upon in advance of treatment. The from use as a gestational carrier for 12 months possibility of pregnancy termination for preg- after documentation that treatment was suc- nancy complications (in the gestational car- cessful before being reconsidered. If evidence rier or fetus) or for multifetal gestations also is presented documenting successful treat- should be discussed before treatment. ment more than 12 months prior, no further 6. Behavior of the gestational carrier: Individ- deferral is needed as long as current testing uals who smoke, consume alcohol (>1 drink does not indicate an active infection. per day) or have other potentially harmful 4. Individuals with false positive results for habits should not be considered as gestational syphilis using non-treponemal assays that carriers. Activity of the carrier (travel, exer- are confirmed to be negative using a trepone- cise, diet, vitamin supplements, etc.) shouldVOL. - NO. - / - 2012 5 SCO 5.1.0 DTD Š FNS27338_proof Š 9 April 2012 Š 3:46 pm Š ce JS
    • PRACTICE COMMITTEE be discussed between the parties and agreed 1. Management during pregnancy of expecta- upon in advance of treatment. tions and relationship with the gestational 7. Compensation to the gestational carrier: carrier and her family Compensation to the gestational carrier 2. Meeting the emotional and physical needs of should be agreed upon in writing in the legal the gestational carrier and her family contract between the intended parents and 3. Understanding the gestational carriers right carrier before any treatment begins. The to make choices for her body over the rights amount of compensation paid to the carrier of the intended parents can be prorated based on the procedure(s) 4. Rights of the gestational carrier to refuse or performed. to accept medical interventions or testing vii. Quarantining of embryos 5. Number of embryos to be transferred and All potential gestational carriers should be number of cycles planned to be determined offered the option of cryopreserving and quar- by the gestational carrier and physician antining embryos derived from the intended 6. Multiple pregnancy and associated risks parents for 6 months, with release of embryos 7. Multifetal pregnancy reduction and discus- only after the intended parents have been re- sion of psychological risks and concerns tested with confirmed negative results (see 8. Possibility of abortion in the event of an section on laboratory testing of gestational car- abnormal fetus riers 3.iv.1-10.). In the event of seroconversion 9. Gestational carriers behavior during preg- of an intended parent after cryopreservation nancy and methods for resolving conflicts of the embryos, the ASRM recommends that (e.g., eating habits, prescription drugs, alcohol) the embryos should not be transferred into 10. Disclosure to offspring a gestational carrier. 11. Disclosure to family members and friends viii. Record keeping 12. Expectations of relationship between gesta- A permanent record of each gestational car- tional carrier, intended parent(s), and chil- riers initial selection process, medical evalua- dren after birth tion, eligibility, and subsequent follow-up 13. Need for gestational carrier and her children evaluations should be maintained indefinitely. to interact with baby after birth The clinical outcome for each cycle should be 14. Disposition of extra embryos recorded. A mechanism must exist to maintain 15. Need for separate legal consultation and such records as a future medical resource for a written contract any offspring produced. 16. Potential guilt reaction of gestational carrier4. Psychosocial consultation for gestational carriers and in- associated with failed attempts or problem tended parents that may arise a. Psychosocial consultation for intended parents 17. Matching of gestational carrier and intended includes: parent(s) i. A clinical interview and psychological assessment 18. Relationship issues, expectations, and im- including the intended parent(s) history of infer- pact of failed cycle tility and methods of coping b. Criteria for rejection of intended parents ii. Psychological evaluation of each intended parent i. Absolute criteria for rejection include: is strongly recommended as a means to alert the 1. Inability to maintain respectful and caring team to significant psychological issues that relationship with gestational carrier could compromise successful collaboration with 2. Abnormal psychological evaluation as deter- the gestational carrier mined by the qualified mental health professional iii. Informing intended parent(s) of potential psy- 3. Unresolved or untreated addiction, child chological issues and risks associated with the abuse, sexual or physical abuse, depression, gestational carrier process eating disorder iv. Discussion of the medical protocol, scheduling 4. Unresolved or untreated major depression, demands, risks of cancelled cycles or unsuccess- bipolar disorder, psychosis, or significant ful cycles, number of embryos transferred, mul- anxiety disorder or personality disorder tiple pregnancy, multifetal pregnancy reduction, 5. Current marital or relationship instability prenatal diagnostic testing, and elective 6. Intended parent(s) failure to agree with gesta- termination tional carriers decision on number of em- v. Requirement of intended parent(s) agreement with bryos transferred the gestational carrier regarding all medical issues ii. Relative criteria for rejection include: vi. Definition of role/function of qualified mental 1. Ongoing legal disputes health professional 2. Significant and ongoing problematic inter- vii. Counseling topics include: personal relationships6 VOL. - NO. - / - 2012 SCO 5.1.0 DTD Š FNS27338_proof Š 9 April 2012 Š 3:46 pm Š ce JS
    • Fertility and Sterility® 3. History of noncompliance or ongoing prob- xxi. Previous gestational carrier experience or lematic interactions with program or medical application to another facility staff xxii. Motivation to become a gestational carrier c. Psychosocial consultation for gestational carriers xxiii. Support of significant other includes: xxiv. Social network i. Informing the potential gestational carrier and xxv. Desire for more children of her own her partner regarding the potential psychological xxvi. Anticipated impact of gestational experience issues and risks associated with the process upon her children and significant other ii. Discussion of the medical protocol, including xxvii. Anticipated type and duration of relationship scheduling demands, risks of cancelled cycle with intended parents and unsuccessful cycle, multiple pregnancy, xxviii. Ability to separate from and relinquish the multifetal pregnancy reduction, prenatal diag- child nostic testing, and elective termination xxix. Anticipated feelings toward the child iii. Discussion of requirement of intended parent(s) xxx. Feelings about multiple pregnancy, bed rest, agreement with gestational carrier regarding all hospitalization, and pregnancy loss medical issues xxxi. Feelings about possible sexual abstinence iv. Definition of role/function of the qualified men- xxxii. Feelings and decisions about termination of tal health professional pregnancy, multifetal pregnancy reduction, v. Counseling topics include: amniocentesis, chorionic villi sampling, and 1. Management of the relationship between the other prenatal diagnostic testing intended parent(s) and the gestational carrier; xxxiii. Reactions to the possibility of becoming infer- past, present, and future tile as a result of the process 2. Coping appropriately with the pregnancy xxxiv. Agreement with the financial compensation 3. Risks of attachment to the child and risk to the arrangement gestational carriers children d. Criteria for rejection of a gestational carrier 4. Impact on gestational carriers marriage or i. Absolute rejection criteria include: partnership 1. Cognitive or emotional inability to comply or 5. Impact on gestational carriers employment consent 6. The balance between the gestational carriers 2. Evidence of financial or emotional coercion right to privacy and the intended parent(s) 3. Abnormal psychological evaluation/testing as right to information determined by the qualified mental health vi. Offer of group/individual counseling with qual- professional ified mental health professional 4. Unresolved or untreated addiction, child vii. Separate, ongoing legal counsel and representa- abuse, sexual abuse, physical abuse, depres- tion for gestational carrier and intended parents sion, eating disorders, or traumatic preg- viii. Informing the gestational carrier of source of nancy, labor and/or delivery gametes before legal consent 5. History of major depression, bipolar disorder, ix. Social history, including family of origin psychosis, or a significant anxiety disorder x. Psychiatric history including prior hospitaliza- 6. Current marital or relationship instability tions, suicide attempts, medication, and counseling 7. Chaotic lifestyle, current major life stressor(s) xi. Occupational and financial history 8. Inability to maintain respectful and caring re- xii. Sexual and reproductive history lationship with intended parent(s) xiii. History of smoking, substance use, and physical, 9. Evidence of emotional inability to separate emotional, or sexual abuse from/surrender the child at birth xiv. History of postpartum disorder(s) and other ii. Relative rejection criteria include: unresolved negative reproductive events 1. Failure to exhibit altruistic commitment to be- xv. Religious beliefs that may influence behavior come a gestational carrier xvi. Maturity, judgment, assertiveness, and decision- 2. Problematic personality disorder making skills 3. Insufficient emotional support from partner/ xvii. Legal history spouse or support system xviii. Negative medical history as it relates to the psy- 4. Excessively stressful family demands chosocial adjustment of being a gestational car- 5. History of conflict with authority rier (e.g., bed rest, gestational diabetes, 6. Inability to perceive and understand the per- preeclampsia) spective of others xix. Personality style and coping skills, capacity for 7. Motivation to use compensation to solve own empathy infertility xx. Current major life stressors or anticipated 8. Unresolved issues with a negative reproduc- changes within the next 2 years tive eventVOL. - NO. - / - 2012 7 SCO 5.1.0 DTD Š FNS27338_proof Š 9 April 2012 Š 3:46 pm Š ce JS
    • PRACTICE COMMITTEEAcknowledgments: This report was developed under the Samantha Pfeifer, M.D.; Marc Fritz, M.D.; Jeffrey Gold-direction of the Practice Committee of the American Society berg, M.D.; R. Dale McClure, M.D.; Roger Lobo, M.D.; Michaelfor Reproductive Medicine (ASRM) in collaboration with the Thomas, M.D.; Eric Widra, M.D.; Mark Licht, M.D.; GlennSociety for Assisted Reproductive Technology (SART) as a ser- Schattman, M.D.; Mark Licht, M.D.; John Collins, M.D.; Mar-vice to its members and other practicing clinicians. Although celle Cedars, M.D.; Catherine Racowsky, Ph.D.; Michael Ver-this document reflects appropriate management of a problem non, Ph.D.; Owen Davis, M.D.; Kurt Barnhart, M.D.; Clarisaencountered in the practice of reproductive medicine, it is not Gracia, M.D., M.S.C.E.; Kim Thornton, M.D.; William Cather-intended to be the only approved standard of practice or to ino, M.D., Ph.D.; Robert Rebar, M.D.; Andrew Ladictate an exclusive course of treatment. Other plans of man- Barbera, Ph.D.agement may be appropriate, taking into account the needs ofthe individual patient, available resources, and institutionalor clinical practice limitations. The Practice Committees and REFERENCESthe Board of Directors of ASRM and SART have approved 1. American Psychological Association. Ethical principles of psychologists andthis report. code of conduct. Available at: http://www.apa.org/ethics/code/index.aspx. This document was reviewed by ASRM members and their Accessed November 22, 2011.input was considered in the preparation of the final docu- 2. Practice Committee of American Society for Reproductive Medicine, Practicement. The following members of the ASRM Practice Commit- Committee of Society for Assisted Reproductive Technology. 2008 Guidelinestee participated in the development of this document. All for gamete and embryo donation: a Practice Committee report. Fertil SterilCommittee members disclosed commercial and financial rela- 2008;90(5 Suppl):S30–44. 3. Society for Assisted Reproductive Technology. Female donor physical exami-tionships with manufacturers or distributors of goods or nation form. Available at: http://www.sart.org/login/. Accessed February 8,services used to treat patients. Members of the Committee 2012.who were found to have conflicts of interest based on the 4. Society for Assisted Reproductive Technologies. Male donor physical exami-relationships disclosed did not participate in the discussion nation form. Available at: http://www.sart.org/login/. Accessed Februaryor development of this document. 8, 2012.8 VOL. - NO. - / - 2012 SCO 5.1.0 DTD Š FNS27338_proof Š 9 April 2012 Š 3:46 pm Š ce JS
    • Fertility and Sterility®1 Recommendations for practices utilizing gestational carriers: an ASRM Practice Committee guideline The Practice Committee of the American Society for Reproductive Medicine and the Practice Committee for the Society for Assisted Reproductive Technology Birmingham, Alabama This document provides the latest recommendations for the use of a gestational carrier, including indications for this technique and the evaluation of carriers and inten- ded parents.VOL. - NO. - / - 2012 SCO 5.1.0 DTD Š FNS27338_proof Š 9 April 2012 Š 3:46 pm Š ce JS