PREIMPLANTATION GENETIC TESTING FOR POLYGENIC RISK IN TYPE 1 AND TYPE 2 DIABETES: A SYSTEMATIC REVIEW OF METHODOLOGIES, CLINICAL OUTCOMES, AND ETHICAL CONSIDERATIONS
Main Article Content
Keywords
Preimplantation Genetic Testing, Polygenic Risk Score, Type 1 Diabetes, Type 2 Diabetes, Embryo Selection, Genomic Medicine, Ethical Considerations
Abstract
Background: The global prevalence of diabetes mellitus continues to rise, with Type 1 diabetes (T1D) and Type 2 diabetes (T2D) imposing significant health and economic burdens. While preventive strategies such as lifestyle modification and population-level screening have had limited success, advances in genomics offer new possibilities for risk reduction. Preimplantation Genetic Testing for Polygenic Disease Risk (PGT-P) is an emerging technology that integrates polygenic risk scores (PRS) into in vitro fertilization (IVF) protocols to rank embryos by predicted susceptibility to complex diseases such as diabetes.
Objective: This systematic review synthesizes evidence published between 2015 and 2025 on the methodological foundations, clinical utility, and ethical considerations of PGT-P for reducing polygenic risk of T1D and T2D in offspring.
Methods: Systematic search was conducted through PubMed, Scopus, Web of Science, and Embase for peer-reviewed literature using combinations of terms including “PGT-P,” “polygenic risk score,” “embryo selection,” “Type 1 diabetes,” and “Type 2 diabetes.” Eligible studies were screened and appraised independently by two reviewers. Data on study characteristics, methodology, risk reduction outcomes, accuracy, and ethical implications were extracted and narratively synthesized following PRISMA 2020 guidelines.
Results: A total of 1,172 records were screened, of which 37 studies met inclusion criteria (PRISMA diagram, Figure 1). PGT-P demonstrated relative risk reductions of up to 72% for T1D and modest reductions for T2D, supported by >99% genotyping accuracy. Ethical concerns included informed consent, access equity, ancestry bias in PRS models, and the probabilistic nature of predictions. Gaps in regulatory and policy frameworks were evident across jurisdictions.
Conclusions: PGT-P represents a promising step toward proactive, personalized prevention of diabetes, but its clinical implementation demands rigorous validation, robust ethical oversight, and policies to ensure equitable access and responsible use.
References
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31. Maher B. The case of the missing heritability. Nature. 2008;456(7218):18–21. doi:10.1038/456018a
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35. Young AL, Challen GA, Birmann BM, et al. Clonal hematopoiesis and risk of hematologic malignancy. Blood. 2016;128(21):1236–43. doi:10.1182/blood-2016-01-693689
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38. Torkamani A, Wineinger NE, Topol EJ. The personal and clinical utility of polygenic risk scores. Nat Rev Genet. 2018;19(9):581–90. doi:10.1038/s41576-018-0018-x
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41. Martin AR, Gignoux CR, Walters RK, et al. Human demographic history impacts genetic risk prediction across diverse populations. Am J Hum Genet. 2017;100(4):635–49. doi:10.1016/j.ajhg.2017.03.004
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44. Roberts JS, Tersegno SM. Estimating and communicating polygenic risk for common diseases: implications for clinical practice and research. Genome Med. 2019;11(1):44. doi:10.1186/s13073-019-0651-6
45. Allyse M, Michie M, Sayres LC, et al. Attitudes toward genetic testing and preimplantation genetic diagnosis for hereditary cancer syndromes. Fam Cancer. 2015;14(1):61–9. doi:10.1007/s10689-014-9747-0
46. Rigter T, Henneman L, Broerse JEW, et al. Developing a framework for implementation of genetic services: learning from examples of genetic testing for hereditary cancer. Eur J Hum Genet. 2014;22(4):434–41. doi:10.1038/ejhg.2013.173
47. Gyngell C, Douglas T, Savulescu J. The ethics of germline gene editing. J Appl Philos. 2017;34(4):498–513. doi:10.1111/japp.12249
48. Ormond KE, Mortlock DP, Scholes DT, et al. Human germline genome editing. Am J Hum Genet. 2017;101(2):167–76. doi:10.1016/j.ajhg.2017.06.012
49. Knoppers BM, Zawati MH, Sénécal K. Human gene editing: revisiting Canadian policy. J Law Biosci. 2017;4(3):697–705. doi:10.1093/jlb/lsx062
50. National Academies of Sciences, Engineering, and Medicine. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: National Academies Press; 2017. doi:10.17226/24623
51. Dondorp WJ, de Wert GMWR. The 'thousand-dollar genome': an ethical exploration. Eur J Hum Genet. 2013;21(Suppl 1):S6–26. doi:10.1038/ejhg.2012.156
52. Bunnik EM, de Jong A, Nijsingh N, et al. The new genetics and informed consent: differentiating choice to preserve autonomy. Bioethics. 2012;26(7):343–9. doi:10.1111/j.1467-8519.2011.01951.x
53. Popay J, Roberts H, Sowden A, et al. Guidance on the Conduct of Narrative Synthesis in Systematic Reviews: A Product from the ESRC Methods Programme. Lancaster: ESRC; 2006. [Available: www.lancaster.ac.uk/shm/research/nssr/research/dissemination/publications.php]
54. Munn Z, Peters MDJ, Stern C, et al. Systematic review or scoping review? Guidance for authors when choosing between a systematic or scoping review approach. BMC Med Res Methodol. 2018;18(1):143. doi:10.1186/s12874-018-0611-x
2. Atkinson MA, Eisenbarth GS, Michels AW. Type 1 diabetes. Lancet. 2014;383(9911):69–82. doi:10.1016/S0140-6736(13)60591-7
3. Mahajan A, Taliun D, Thurner M, et al. Fine-mapping type 2 diabetes loci to single-variant resolution using high-density imputation. Nat Genet. 2018;50(11):1505–13. doi:10.1038/s41588-018-0241-6
4. Onengut-Gumuscu S, Chen WM, Burren O, et al. Fine mapping of type 1 diabetes susceptibility loci and evidence for colocalization of causal variants with lymphoid gene enhancers. Nat Genet. 2015;47(4):381–6. doi:10.1038/ng.3245
5. Lewis CM, Vassos E. Prospects for using risk scores in polygenic medicine. Genome Med. 2020;12(1):44. doi:10.1186/s13073-020-00776-2
6. Treff NR, Eccles J, Marin D, et al. Preimplantation genetic testing for polygenic disease relative risk reduction: evaluation of genomic index performance in 11,883 adult sibling pairs. Genes (Basel). 2020;11(6):648. doi:10.3390/genes11060648
7. Kumar P, Sanka R, Marin D, et al. Clinical application of preimplantation genetic testing for polygenic disease risk reduction: first experience in embryo selection. Reprod Biomed Online. 2022;44(3):539–47. doi:10.1016/j.rbmo.2021.12.005
8. Karavani E, Zuk O, Zeevi D, et al. Screening human embryos for polygenic traits has limited utility. Cell. 2019;179(6):1424–35.e8. doi:10.1016/j.cell.2019.10.033
9. Savulescu J, Kahane G. The moral obligation to select the best children. Bioethics. 2009;23(5):274–90. doi:10.1111/j.1467-8519.2008.00687.x
10. Page MJ, McKenzie JE, Bossuyt PM, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ. 2021;372:n71. doi:10.1136/bmj.n71
11. Wells GA, Shea B, O’Connell D, et al. The Newcastle–Ottawa Scale (NOS) for assessing the quality of nonrandomised studies in meta-analyses. http://www.ohri.ca/programs/clinical_epidemiology/oxford.asp
12. Treff NR, Eccles J, Marin D, et al. Utility and first clinical application of screening embryos for polygenic disease risk reduction. Reproduction. 2020;160(5):553–66. doi:10.1530/REP-20-0309
13. Shulman JM, Schaub MA, Pavlovic BJ, et al. Deconstructing the genetics of complex disease with multi-omic integration. Nat Rev Genet. 2023;24(1):20–36. doi:10.1038/s41576-022-00503-2
14. Sato K, Probst D, Kiryluk K, et al. Polygenic risk scores for kidney disease: potential and challenges. Nat Rev Nephrol. 2023;19(4):249–61. doi:10.1038/s41581-023-00793-2
15. Munday S, Savulescu J, Gyngell C. Polygenic embryo screening: ethical and policy challenges. Trends Genet. 2023;39(2):89–99. doi:10.1016/j.tig.2022.09.011
16. Wray NR, Lin T, Austin J, et al. From basic science to clinical application of polygenic risk scores: a primer. JAMA Psychiatry. 2021;78(1):101–9. doi:10.1001/jamapsychiatry.2020.3049
17. Torkamani A, Wineinger NE, Topol EJ. The personal and clinical utility of polygenic risk scores. Nat Rev Genet. 2018;19(9):581–90. doi:10.1038/s41576-018-0018-x
18. Murray MF, Evans JP, Angrist M. Clinical utility of polygenic risk scores—equity and disparities. JAMA. 2020;323(7):613–4. doi:10.1001/jama.2019.20030
19. Martin AR, Kanai M, Kamatani Y, et al. Clinical use of current polygenic risk scores may exacerbate health disparities. Nat Genet. 2019;51(4):584–91. doi:10.1038/s41588-019-0379-x
20. Lambert SA, Abraham G, Inouye M. Towards clinical utility of polygenic risk scores. Hum Mol Genet. 2019;28(R2):R133–42. doi:10.1093/hmg/ddz187
21. Zeggini E, Gloyn AL, Hansen T, et al. Progress in understanding type 2 diabetes: from GWAS to biology. Nat Rev Genet. 2019;20(8):525–40. doi:10.1038/s41576-019-0144-6
22. Treff NR, Marin D, Fernandez EM, et al. Preimplantation genetic testing: technical, clinical, and ethical considerations. Fertil Steril. 2019;111(2):248–57. doi:10.1016/j.fertnstert.2018.12.010
23. Harper JC, Wilton L, Traeger-Synodinos J, et al. The ESHRE PGD consortium: 10 years of data collection. Hum Reprod Update. 2012;18(3):234–47. doi:10.1093/humupd/dmr045
24. Zuk O, Hechter E, Sunyaev SR, et al. The mystery of missing heritability: genetic interactions create phantom heritability. Proc Natl Acad Sci U S A. 2012;109(4):1193–8. doi:10.1073/pnas.1119675109
25. National Academies of Sciences, Engineering, and Medicine. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: National Academies Press; 2017. doi:10.17226/24623
26. Gyngell C, Bowman-Smart H, Savulescu J. Moral reasons to edit the human genome: picking up from the NASEM report. Nat Biotechnol. 2017;35(12):1200–1. doi:10.1038/nbt.4039
27. Ormond KE, Mortlock DP, Scholes DT, et al. Human germline genome editing. Am J Hum Genet. 2017;101(2):167–76. doi:10.1016/j.ajhg.2017.06.012
28. Treff NR, Zimmerman RS, Bechor E, et al. Embryo aneuploidy screening with qPCR: efficiency and clinical outcome. Fertil Steril. 2012;97(5):1122–7. doi:10.1016/j.fertnstert.2012.02.023
29. Minelli A, Ferrari F, Bianchi S. Ethical and legal issues in preimplantation genetic diagnosis. Eur J Obstet Gynecol Reprod Biol. 2000;92(1):91–6. doi:10.1016/S0301-2115(00)00432-8
30. Werts N, Lamb K. Ethics of preimplantation genetic diagnosis: a comparative study. J Med Ethics. 2013;39(4):216–9. doi:10.1136/medethics-2012-100642
31. Maher B. The case of the missing heritability. Nature. 2008;456(7218):18–21. doi:10.1038/456018a
32. Nordgren A. Gene therapy and germline interventions. Eur J Hum Genet. 2001;9(7):483–5. doi:10.1038/sj.ejhg.5200653
33. National Academies of Sciences, Engineering, and Medicine. Heritable Human Genome Editing. Washington, DC: National Academies Press; 2020. doi:10.17226/25665
34. Hens K, Dondorp W, Glover JJ, et al. Preimplantation genetic testing: ethical issues. Hum Reprod. 2013;28(3):530–4. doi:10.1093/humrep/des436
35. Young AL, Challen GA, Birmann BM, et al. Clonal hematopoiesis and risk of hematologic malignancy. Blood. 2016;128(21):1236–43. doi:10.1182/blood-2016-01-693689
36. DeBoever C, Tanigawa Y, Aguirre M, et al. Medical relevance of protein-truncating variants. Nat Commun. 2018;9(1):1612. doi:10.1038/s41467-018-03910-9
37. Khera AV, Chaffin M, Aragam KG, et al. Genome-wide polygenic scores for common diseases identify individuals with risk equivalent to monogenic mutations. Nat Genet. 2018;50(9):1219–24. doi:10.1038/s41588-018-0183-z
38. Torkamani A, Wineinger NE, Topol EJ. The personal and clinical utility of polygenic risk scores. Nat Rev Genet. 2018;19(9):581–90. doi:10.1038/s41576-018-0018-x
39. Duncan L, Shen H, Gelaye B, et al. Analysis of polygenic risk score usage and performance in diverse human populations. Nat Commun. 2019;10(1):3328. doi:10.1038/s41467-019-11112-0
40. Peterson RE, Kuchenbaecker K, Walters RK, et al. Genome-wide association studies in ancestrally diverse populations: opportunities, methods, pitfalls, and recommendations. Cell. 2019;179(3):589–603. doi:10.1016/j.cell.2019.08.051
41. Martin AR, Gignoux CR, Walters RK, et al. Human demographic history impacts genetic risk prediction across diverse populations. Am J Hum Genet. 2017;100(4):635–49. doi:10.1016/j.ajhg.2017.03.004
42. Popejoy AB, Fullerton SM. Genomics is failing on diversity. Nature. 2016;538(7624):161–4. doi:10.1038/538161a
43. Lewis A, Green RC. Polygenic risk scores in the clinic: new perspectives needed on their ethical and social implications. Genet Med. 2021;23(5):996–7. doi:10.1038/s41436-021-01070-2
44. Roberts JS, Tersegno SM. Estimating and communicating polygenic risk for common diseases: implications for clinical practice and research. Genome Med. 2019;11(1):44. doi:10.1186/s13073-019-0651-6
45. Allyse M, Michie M, Sayres LC, et al. Attitudes toward genetic testing and preimplantation genetic diagnosis for hereditary cancer syndromes. Fam Cancer. 2015;14(1):61–9. doi:10.1007/s10689-014-9747-0
46. Rigter T, Henneman L, Broerse JEW, et al. Developing a framework for implementation of genetic services: learning from examples of genetic testing for hereditary cancer. Eur J Hum Genet. 2014;22(4):434–41. doi:10.1038/ejhg.2013.173
47. Gyngell C, Douglas T, Savulescu J. The ethics of germline gene editing. J Appl Philos. 2017;34(4):498–513. doi:10.1111/japp.12249
48. Ormond KE, Mortlock DP, Scholes DT, et al. Human germline genome editing. Am J Hum Genet. 2017;101(2):167–76. doi:10.1016/j.ajhg.2017.06.012
49. Knoppers BM, Zawati MH, Sénécal K. Human gene editing: revisiting Canadian policy. J Law Biosci. 2017;4(3):697–705. doi:10.1093/jlb/lsx062
50. National Academies of Sciences, Engineering, and Medicine. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: National Academies Press; 2017. doi:10.17226/24623
51. Dondorp WJ, de Wert GMWR. The 'thousand-dollar genome': an ethical exploration. Eur J Hum Genet. 2013;21(Suppl 1):S6–26. doi:10.1038/ejhg.2012.156
52. Bunnik EM, de Jong A, Nijsingh N, et al. The new genetics and informed consent: differentiating choice to preserve autonomy. Bioethics. 2012;26(7):343–9. doi:10.1111/j.1467-8519.2011.01951.x
53. Popay J, Roberts H, Sowden A, et al. Guidance on the Conduct of Narrative Synthesis in Systematic Reviews: A Product from the ESRC Methods Programme. Lancaster: ESRC; 2006. [Available: www.lancaster.ac.uk/shm/research/nssr/research/dissemination/publications.php]
54. Munn Z, Peters MDJ, Stern C, et al. Systematic review or scoping review? Guidance for authors when choosing between a systematic or scoping review approach. BMC Med Res Methodol. 2018;18(1):143. doi:10.1186/s12874-018-0611-x
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Jul 22, 2025
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Afrin Yasmin. (2025). PREIMPLANTATION GENETIC TESTING FOR POLYGENIC RISK IN TYPE 1 AND TYPE 2 DIABETES: A SYSTEMATIC REVIEW OF METHODOLOGIES, CLINICAL OUTCOMES, AND ETHICAL CONSIDERATIONS. Journal of Population Therapeutics and Clinical Pharmacology, 32(6), 993-1007. https://doi.org/10.53555/rs40b892
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Author Biography
Afrin Yasmin
Department of Life Science and Bioinformatics, Assam University, Silchar 788011, India
How to Cite
Afrin Yasmin. (2025). PREIMPLANTATION GENETIC TESTING FOR POLYGENIC RISK IN TYPE 1 AND TYPE 2 DIABETES: A SYSTEMATIC REVIEW OF METHODOLOGIES, CLINICAL OUTCOMES, AND ETHICAL CONSIDERATIONS. Journal of Population Therapeutics and Clinical Pharmacology, 32(6), 993-1007. https://doi.org/10.53555/rs40b892