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Regulation of the ART Laboratory

  • Doris J. Baker
Chapter

Abstract

Assisted reproductive technology (ART) laboratories are an integral component of assisted reproductive medical practices. By definition ART refers to all treatments or procedures that include the in vitro handling of both human oocytes and sperm, or embryos, for the purpose of establishing a pregnancy. The field of ART was established in the 1970s with successful in vitro fertilization (IVF) and embryo transfer for the treatment of infertility. The field has expanded to include procedures and services for third-party reproduction, fertility preservation, and sex selection. Genetic screening is available for the purpose of transferring healthy embryos only. In the forefront are mitochondrial replacement techniques for prevention of mitochondrial disease passed from mother to child, and that result in offspring carrying DNA from three different individuals. Embryologists with varying education and certification perform these highly complex procedures. The field continues to grow with 4,461,309 ART cycles initiated for the triennium (2008–2010) resulting in 1,144,858 live births worldwide. Supervision of ART laboratories, including acceptable practices and requirements for personnel performing these multifaceted and often controversial techniques, varies among states. Oversight may be via statute, directive, guidelines, licensing, and accreditation, or the ART laboratory and embryologists may function without benefit of any type of scrutiny.

Keywords

Accreditation Assisted reproductive technology ART interventions ART laboratory Certification Continuing Professional Development Directive Embryologist Embryology Guideline Law Legal License Licensing body Mandate Oversight Regulation Standard Statute 

References

  1. 1.
    Dyer S, Chambers GM, de Mouzon J, Nygren KG, Zegers-Hochschild FS, Mansour R, Ishihara O, Banker M, Adamson GD. International Committee for Monitoring Assisted Reproductive Technology 2008, 2009 and 2010. Hum Reprod. 2016;31(7):1–23.CrossRefGoogle Scholar
  2. 2.
  3. 3.
    Sullivan EA, Zegers-Hochschild F, Mansour R, Ishihara O, de Mouzon J, Nygren KG, Adamson GD. International Committee for Monitoring Assisted Reproductive Technology (ICMART) world report: assisted reproductive technology 2004. Hum Reprod. 2013;28(5):1375–90.PubMedCrossRefGoogle Scholar
  4. 4.
    Ory S, Devroey S. IFFS Surveillance 2013. Int Fed Fertil Soc. 2013:1–129.Google Scholar
  5. 5.
    ICMART, prepared by Nygren KG, Sullivan E, Zegers-Hochschild F, Mansour R, Ishihara O, Adamson GD, de Mouzon J. International Committee for Monitoring Assisted Reproductive Technology (ICMART) world report: assisted reproductive technology 2003. Fertil Steril. 2011;95:2209–22.CrossRefGoogle Scholar
  6. 6.
    Jones W, Cooke I, Kempers R, Brisden P, Saunders D. International Federation of Fertility Societies Surveillance 2010. Fertil Steril. 2011;95:491.PubMedCrossRefGoogle Scholar
  7. 7.
    Zegers-Hothschild FA, Adamson GD, de Mouzon J, et al. International Committee for Monitoring Assisted Reproductive Technology (ICMART) and the World Health Organization (WHO) revised glossary of ART terminology, 2009. Fertil Steril. 2009;92(5):1520–4.CrossRefGoogle Scholar
  8. 8.
    Jones HW Jr, Cohen J. IFFS surveillance 07. Fertil Steril. 2007;87(4 Suppl):S1–67.PubMedGoogle Scholar
  9. 9.
    Adamson GD, de Mouzon J, Lancaster P, Nygren KG, Sullivan E, Zegers-Hochschild F. World collaborative report on in vitro fertilization, 2000. Fertil Steril. 2006;85(6):1586–622.PubMedCrossRefGoogle Scholar
  10. 10.
    Lancaster P. Worldwide variations in the use of ART services. In: Abstracts of the 22nd annual meeting of the ESHRE, Prague; 2006. p. 123–4.Google Scholar
  11. 11.
    de Mouzon J, Lancaster P, Nygren KG, et al. World collaborative report on assisted reproductive technology, 2002. Hum Reprod. 2009;24(9):2310–20.PubMedCrossRefGoogle Scholar
  12. 12.
    Palemro G, Joris H, Devroey P, Van Steirteghem AC. Pregnancies after intracytoplasmic injection of a single spermatozoon into an oocyte. Lancet. 1992;340(8810):17–8.CrossRefGoogle Scholar
  13. 13.
    ICSI (Intracytoplasmic sperm injection). Cornell University. 2010. http://www.cornellurology.com/uro/cornell/infertility/srt/icsi.shtml.
  14. 14.
    Tucker MJ, Wright G, Morton PC, Massey JB. Birth after cryopreservation of immature oocytes with subsequent in vitro maturation. Fertil Steril. 1998;70(3):578–9.PubMedCrossRefGoogle Scholar
  15. 15.
    Beeson D, Karnovsky M, Lippman A. What’s in a name? Variations in terminology of third-party reproduction. Repro Biomed. 2015;(6):805–14.PubMedCrossRefGoogle Scholar
  16. 16.
    Kushnir VA, Darmon SK, Shapiro AJ, Albertini DF, Barade DH, Gleicher N. Utilization of third-party in vitro fertilization in the United States. Am J Obstst Gynecol. 2016;16:32019–1.Google Scholar
  17. 17.
    Third-party reproduction: sperm, egg and embryo donation and surrogacy. ASRM Guide for Patients. 2012:1–18.Google Scholar
  18. 18.
    Levy R, Elder K, Ménézo Y. Cytoplasmic transfer in oocytes: biochemical aspects. Human Reprod Update. 2004;10(3):241–50.CrossRefGoogle Scholar
  19. 19.
    Gestational carrier: Surrogate. ASRM Fact Sheet. 2012. Reproductive Facts.org. https://www.asrm.org/FACTSHEET_Gestational_Carrier_Surrogate/.
  20. 20.
    Ethics Committee of the American Society for Reproductive Medicine. Posthumous collection and use of reproductive tissues: A committee report. Fertil Steril. 2013;99:1842–5.CrossRefGoogle Scholar
  21. 21.
    Verlinsky Y, Kuliev A. Atlas of preimplantation genetic diagnosis. 2nd ed. Roca Raton: Taylor & Francis Group; 2005.Google Scholar
  22. 22.
    Stern HJ. Preimplantaton genetic diagnosis: prenatal testing for embryos finally achieving its potential. Clin Med. 2014;3(1):280–309.CrossRefGoogle Scholar
  23. 23.
    ASRM Ethics Committee Report. Sex selection and preimplantation genetic diagnosis. Fertil Steril. 2004;82:S245–8.Google Scholar
  24. 24.
    ASRM Ethics Committee Report. Preconception gender selection for nonmedical reasons. Fertil Steril. 2004;82(S1):232–5.Google Scholar
  25. 25.
    FDA considers mitochondrial replacement. MedScape. 2 January, 2017. http://www.medscape.com/viewarticle/821115.
  26. 26.
    Center for Genetics and Society. 3-person IVF: A Resource Page. 2016:1–9. http://www.geneticsandsociety.org/article.php?id=6527.
  27. 27.
    Brennan Z. Expert Committee: FDA should approve mitochondrial replacement trials under certain conditions. Regulatory Affairs Professional Societies. 2016. http://raps.org/Regulatory-Focus/News/2016/02/03/24245/Expert-Committee-FDA-Should-Allow-Mitochondrial-Replacement-Trials-Under-Certain-Conditions/.
  28. 28.
    Reardon S. US panel greenlights creation of male ‘three-person’ embryos. Nature. 2016;530:142.PubMedCrossRefGoogle Scholar
  29. 29.
    Health and Medicine Consensus Study. Hlth and Med Div. Ethical and social policy considerations of Novel techniques for prevention of maternal transmission of mitochondrial DNA diseases. National Academies of Science, Engineering, and Medicine. 2016.Google Scholar
  30. 30.
    Castro R. Mitochondrial replacement therapy: The UK and US regulatory landscapes. J Law Biosci. 2016;3(3):726–35.PubMedPubMedCentralCrossRefGoogle Scholar
  31. 31.
    Diamond R. Social and ethical issues in mitochondrial donation. Br Med Bull. 2015;115(1):173–82.CrossRefGoogle Scholar
  32. 32.
    Schatten H, Sun Q, Prather R. The impact of mitochondrial function/dysfunction on IVF and new treatment possibilities for infertility. Reprod Biol Endocrinol. 2014;12:111.PubMedPubMedCentralCrossRefGoogle Scholar
  33. 33.
    FDA. February 25-26, 2014: Cellular, Tissue, and Gene Therapies Advisory Committee Meeting: Announcement. http://www.fda.gov/AdvisoryCommittees/Calendar/ucm380042.html.
  34. 34.
  35. 35.
  36. 36.
    Human Fertilisation and Embryology Act 1990. Chapter 37. www.hfea.gov.uk. Accessed 2016.
  37. 37.
    CFR—Code of Federal Regulations Title 21 Part 1271. Human cells, tissues, and cellular and tissue-based products. 66 Fed Regist. 2001;5466:19.Google Scholar
  38. 38.
  39. 39.
    Directive 2004/23/EC of the European Parliament and of the Council. Official Journal of the European Union; 31 March 2004:L012/48.Google Scholar
  40. 40.
  41. 41.
  42. 42.
    Practice Committee Report. Recommended practice for the management of embryology, andrology, and endocrinology. Fertil Steril. 2014;102:960–3.CrossRefGoogle Scholar
  43. 43.
  44. 44.
  45. 45.
  46. 46.
    CLIA Subpart A; General Provisions. 57 FR 7139: Federal Register; 1992.Google Scholar
  47. 47.
  48. 48.
    Steptoe PC, Edwards RG. Birth after the reimplantation of a human embryo. Lancet. 1978;312(8085):366.CrossRefGoogle Scholar
  49. 49.
    Morgan LM. IVF ban lifted in Costa Rica: a success for human rights. Cent Genet Soc. 2016 http://www.geneticsandsociety.org/article.php?id=9298.
  50. 50.
    Congregation for the Doctrine of the Faith. Instruction on respect for human life in its origin and the dignity of procreation relies on certain questions of the day. The Vatican: The Linacre Quarterly; 1987. p. 54.Google Scholar
  51. 51.
    Poole B, Mikki TB, Moore AA, Jebhardt D, Dasig D. Preliminary clinical experience with human blastocyst development in vitro without co-culture. Hum Reprod. 1999;14(2):454=-7.. Oxford.Google Scholar
  52. 52.
    Walters EM, Benson JD, Woods EJ, Critser JK. The history of sperm cryopreservation. University Press. In: Pacey AA, Tomlinson MJ, editors. Sperm banking: theory and practice. New York: Cambridge University Press. © Cambridge University Press; 2009.Google Scholar
  53. 53.
    Onefre J, Baert Y, Faes K, Goossens E. Cryopreservation of testicular tissues or testicular cell suspensions: a pivotal step in fertility preservation. Hum Reprod Update. 2016;22(06):744–61.CrossRefGoogle Scholar
  54. 54.
    Argyle CE, Harper JC, Davies MC. Oocyte cryopreservation: where are we now? Hum Reprod Update. 2016;22(4):440–9.PubMedPubMedCentralCrossRefGoogle Scholar
  55. 55.
    Oktay K, Tilly J. Livebirth after cryopreserved ovarian tissue autotransplantation. Lancet. 2004;364(9443):1405–10.CrossRefGoogle Scholar
  56. 56.
    Lieberman J, Nawroth F, Isachenko V, Isachenko E, Rhimi G, Tucker MJ. Potential importance of vitrification in reproductive medicine. Biol Reprod. 2002;67(6):1671.CrossRefGoogle Scholar
  57. 57.
    Antinori S, Pancireact C, Selman H, Versaci C. Zona thinning with the use of laser: a new approach to assisted hatching in humans. Hum Reprod. 1996;11(3):590–4.PubMedCrossRefGoogle Scholar
  58. 58.
    Hu Scott R, Schimmel T, et al. Birth of infant after transfer of anucleate donor oocyte cytoplasm into recipient eggs. Lancet. 1997;350:186–7.CrossRefGoogle Scholar
  59. 59.
    Cohen J, Scott R, Alikani M, et al. Ooplasmic transfer in mature human oocytes. Mol Hum Reprod. 1998;4:269–80.PubMedCrossRefGoogle Scholar
  60. 60.
    Cloning. National Human Genome Research Institute Fact Sheets. 2016. https://www.genome.gov/25020028/.
  61. 61.
    Cloning: Medline Plus. 2016. www.medlineplus.gov.
  62. 62.
    Belva F, Boonduelle M, Roelants M, Michielsen D, Van Steirteghern A, Verheyen G, Tournaye H. Semen quality of young adult ICSI offspring: the first results. Hum Reprod. 2016:1–10.Google Scholar
  63. 63.
    Kissin DM, Kulkarni AD, Mneimneh A, Warner L, Boulet SL, Crawford S, Jamieson DJ. Embryo transfer practices and multiple births resulting from assisted reproductive technology: an opportunity for prevention. Fertil Steril. 2015;103(4):954–61.PubMedPubMedCentralCrossRefGoogle Scholar
  64. 64.
    Chambers GM, Hoang VP, Lee E, Hansen M, Sullivan EA, Bower C, Chapman M. Hospital costs of multiple-birth and singleton-birth children during the first 5 years of life and the role of assisted reproductive technology. JAMA Pediatr. 2014;168(11):1045–53.PubMedCrossRefGoogle Scholar
  65. 65.
    Simpson JL. Birth defects and assisted reproductive technologies. Semin Fetal Neonatal Med. 2014;19(3):177–82.PubMedCrossRefGoogle Scholar
  66. 66.
    Kulkarni D, Jamison DJ, Hones HW, Kssin DM, Gallo MF, Maculuso M, Adashi E, Maria F. Fertility treatments and multiple births in the United States. NEJM N Engl J Med. 2013;3(69):2218–25.CrossRefGoogle Scholar
  67. 67.
    Lu U, Wang N, Jin F. Long-term follow-up of children conceived through assisted reproductive technology. J Zheliang Univ Sci B. 2013;14(5):359–71.CrossRefGoogle Scholar
  68. 68.
    Tandulwadkar S, Lodha P, Kharb V. Congenital malformations and assisted reproductive technique: where is assisted reproductive technique taking us? J Hum Reprod Sci. 2012;5(3):244–7.PubMedPubMedCentralCrossRefGoogle Scholar
  69. 69.
    Bridges P, Jeoung M, Kim H, Kim JH, Lee DR, Co C, Baker DJ. Methodology matters: IVF versus ICSI and embryonic gene expression. Reprod Biomed Online. 2011;23(2):233–44.CrossRefGoogle Scholar
  70. 70.
    Poret H, Blanchard M, Lemseffer DR, Guerif F. Conjoined twins after intracytoplasmic sperm injection and transfer of single day 2 embryo: case report. Fertil Steril. 2010;93(1):268.PubMedCrossRefGoogle Scholar
  71. 71.
    IVF children may have altered gene activity, study finds. IVF.net. 2010. http://www.ivf.net/ivf/ivf_children_may_have_altered_gene_activity_study_finds-o4728.html.
  72. 72.
    IVF boys have shorter fingers, may have fertility problems. 2010. http://www.ivf.net/ivf/ivf_boys_have_shorter_fingers_may_have_fertility_problems-o4826.html.
  73. 73.
    Owen C, Segars JH. Imprinting disorders and assisted reproductive technology. Semin Reprod Med. 2009;27(5):417–28.PubMedPubMedCentralCrossRefGoogle Scholar
  74. 74.
    Haimov-Kochman R, Daum H, Lossos E, et al. Monozygotic multiple gestation after intracytoplasmic sperm injection and preimplantation genetic diagnosis. Fertil Steril. 2009;92(6):2037.PubMedCrossRefGoogle Scholar
  75. 75.
    Alukal JP, Lamb DJ. Intracytoplasmic sperm injection (ICSI)–what are the risks? Urol Clin North Am. 2008;35(2):277–88.PubMedPubMedCentralCrossRefGoogle Scholar
  76. 76.
    CDC Press Release. National Birth Defects Prevention Study Shows Assisted Reproductive Technology is Associated with an Increased Risk of Certain Birth Defects. 2008. https://www.cdc.gov/media/pressrel/2008/r081117.htm.
  77. 77.
    Miura K, Niikawa N. Do monochorionic dizygotic twins increase after pregnancy by assisted reproductive technology? J Hum Genet. 2005;50(1):1–6.PubMedCrossRefGoogle Scholar
  78. 78.
    Williams CA, Wallace MR, Drury KC, Kipersztok S, Edwards RK, Williams RS, Haller MJ, Schaz DA, Silverstein JH, Gray BA, Zori RT. Blood lymphocyte Chimerism associated with IVF and monochorionic dizygous twinning: case report. Hum Reprod. 2004;19(12):2816–21.PubMedCrossRefGoogle Scholar
  79. 79.
    Simon-Bouy B, Plachot M, Mokdad A, Lavaud N, Muti C, Bazin A, Vialard F, Belaisch-Allart J. Possible human chimera detected prenatally after in vitro fertilization: a case report. Prenat Diagn. 2003;23(11):935–7.PubMedCrossRefGoogle Scholar
  80. 80.
    Katz P, Nachtigall R, Showstack J. The economic impact of the assisted reproductive technologies. Nature Publishing Group; 2002. 1–9. http://www.nature.com/fertility/content/full/ncb-nm-fertilitys29.html; Ryu HM, Lin WW, Lamb DJ, Chuang W, Lipshultz LI, Bischoff FZ. Increased chromosome X, Y, and 18 nondisjunction in sperm from infertile patients that were identified as normal by strict morphology: implication for intracytoplasmic sperm injection. Fertil Steril 2001;76(5):879–83.
  81. 81.
    Lamb DJ. Debate: is ICSI a genetic time bomb? Yes J Androl. 1999;20(1):23–33.PubMedGoogle Scholar
  82. 82.
    Strain L, Dean JC, Hamilton MP, Bonthron DT. A true hermaphrodite chimera resulting from embryo from amalgamation after in vitro fertilization. NEJM N Engl J Med. 1998;338(3):166–9.PubMedCrossRefGoogle Scholar
  83. 83.
    Kim ED, Bischoff FZ, Lipshultz LI, Lamb DJ. Genetic concerns for the subfertile male in the era of ICSI. Prenat Diagn. 1998;18(13):1349.PubMedCrossRefGoogle Scholar
  84. 84.
    Weiss R. Boy with mixed anatomy adds to scrutiny of in vitro fertilization. Washington Post; 15 Jan 1998.Google Scholar
  85. 85.
    Strain L. A true hermaphrodite chimera resulting from amalgamation after in vitro fertilization. NEJM N Engl J Med. 1998;338(3):166–9.PubMedCrossRefGoogle Scholar
  86. 86.
    Ravichandran K, Guzman L, Escudero T, Zhenng XX, Colls P, Jordan A, Cohen J, Wells D, Munne S. Causes and estimated incidences of sex-chromosome misdiagnosis in preimplantation genetic diagnosis of aneuploidy. Reprod Biomed Online. 2016;33(5):550–9.PubMedCrossRefGoogle Scholar
  87. 87.
    Sakkas D, Pool TB, Barrett CB. Analyzing IVF laboratory error rates: highlight or hide? Reprod Biomed Online. 2015;31(4):447–8.Kirkey S. Switched embryos and wrong sperm: IVF-mix-ups lead to babies born with ‘unintended parentage’. Health. 2016: 1–5.PubMedCrossRefGoogle Scholar
  88. 88.
    Mix-ups lead to babies born with ‘unintended parentage’. Health. 2016. Pages 1–5 http://news.nationalpost.com/health/ivf-mix-ups-lead-to-babies-born-with-unintended-parentage.
  89. 89.
    Hamzelou J. Barcode your egg and sperm cells to avoid IVF mix-ups. NewScientist 20 May 2015. https://www.newscientist.com/article/mg22630224-800-barcode-your-egg-and-sperm-cells-to-avoid-ivf-mx-ups/.
  90. 90.
    Forman D. Mixed-up embryos, missing gametes and other medical mishaps. Path 2 Parenthood. 2014:1–5. http://www.path2parenthood.org/article/mixed-up-embryos-missing-gametes-and-other-medical-mishaps/.
  91. 91.
    Thornhill A, Brunetti O, Bird S. Measuring human error in the IVF laboratory using an electronic witnessing system. Monduzzi Editorale Proc l 17th Code: 522; World Congress on Controversies in Obstetrics, Gynecology & Infertility (COGI). 2013: 522-101-106.Google Scholar
  92. 92.
    Court rules on IVF mix-up. Guardian News and Media Limited. 2010. http://www.guardian.co.uk/uk/2003/feb/26/2. Accessed 26 Feb 2010; Glaister D. US couple sue clinic for sperm sample mix-up. The Guardian; 23 Mar 2007.
  93. 93.
    U.K. sperm mix-up gives white couple black twins. LifeSiteNews.com; 8 July 2002.Google Scholar
  94. 94.
    Yoon HG, Yoon SH, Son WY, et al. Pregnancies resulting from in vitro matured oocytes collected from women with regular menstrual cycle. J Assist Reprod Genet. 2001;18:325–9.PubMedPubMedCentralCrossRefGoogle Scholar
  95. 95.
    Letterie G. Outcomes of medical malpractice claims in assisted reproductive technology over a ten year period from a single carrier. Fertil Steril. 2016;105(2S):1–2.Google Scholar
  96. 96.
    Greco E, Fabosssi G, Ruberti A, Zavaglia D, Minasi MG. Preimplantation genetic diagnosis and biopsy techniques: important considerations. ARSci. 2013;1(2):7–14.CrossRefGoogle Scholar
  97. 97.
    Kovacic B, Plas C, Woodward BJ, Berheyen G, Prados FJ, Hreinsson J, De los Santos MJ, Magli MC, Lundin K, Plancha CE. The educational and professional status of clinical embryology and clinical embryologists in Europe. Hum Reprod. 2015;30(8):1755–62.PubMedCrossRefGoogle Scholar
  98. 98.
    Australian Health Care Practitioner Regulatory Agency. 2009. https://www.ahpra.gov.au.
  99. 99.
    CLIA definition of medical laboratory. http://medical-dictionary.thefreedictionary.com/CLIA.
  100. 100.
    Birenbaum M. AAB files suit against HHS to enforce CLIA. Embryol News. 1999;II(II):5–6.Google Scholar
  101. 101.
    Alpha Scientists in Reproductive Medicine. The Alpha consensus meeting on the professional status of the clinical embryologist: proceedings of an expert meeting. Reprod Biomed Online. 2015;30:451–61.CrossRefGoogle Scholar
  102. 102.
  103. 103.
    Baker DJ. Reproductive sciences Ph.D. at the University of Kentucky. J Clin Embryol. 2009;12(2):13–23.Google Scholar
  104. 104.
    University of Kentucky does not accept reproductive laboratory science students. https://wwwukyedu/chs/academic-programs/clinical-sciences/reproductive-science 2016.
  105. 105.
  106. 106.
    NAACLS Guide. www.NAACLS.org. 2016.
  107. 107.
    ASCP Certification. www.ASCP.org. 2016.
  108. 108.
    ESHRE Certification. www.eshre.eu. 2016.
  109. 109.
    CAP Accreditation. www.cap.org. 2016.
  110. 110.
    Joint Commission. www.jointcommission.org. 2016.
  111. 111.
    ABB Certification. www.aab.org. 2016.
  112. 112.
    EU Tissue Directive. www.hfea.gov.uk. 2016.
  113. 113.
  114. 114.
  115. 115.
    Vanden FM, Nikiforaki D, Heindryckx B. Assisted oocyte activation following ICSI fertilization failure. Reprod Biomed Online. 2014;28(5):560–71.CrossRefGoogle Scholar
  116. 116.
  117. 117.

Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  • Doris J. Baker
    • 1
  1. 1.Mercer University School of Medicine, Basic Medical SciencesMaconUSA

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