台灣人工生殖法立法前後五年生殖結果的比較

Reproductive outcomes of in vitro fertilisation in the five years before and after the legislation of the Assisted Reproduction Act in Taiwan

10.6288/TJPH.202110_40(5).110076

虞希正(Hsi-Cheng Yu)；雷文玫(Wen-May Rei)；邱淑媞(Shu-Ti Chiou)；鄧宗業(Chung-Yeh Deng)

台灣人工生殖法 ； 試管嬰兒 ； 活產 ； 流產 ； Assisted Reproduction Act ； in vitro fertilization ； live-birth ； miscarriage

台灣公共衛生雜誌

40卷5期（2021 / 10 / 29）

556 - 569

繁體中文

目標：利用台灣人工生殖資料庫探進行實證分析，探討2007年台灣人工生殖法頒布前後，對首次執行試管嬰兒治療成果之影響。方法：擷取人工生殖資料庫中法頒布前與後五年紀錄，利用變異數分析與卡方分析，及廣義線性模型之多變項羅吉斯回歸，比較臨床懷孕、活產、流產、子宮外孕等療程結果。結果：研究共納入2002-2012間83,264次試管嬰兒療程。單變項觀察到立法後五年期間，在著床為胚囊、臨床懷孕及活產率，皆較立法前五年顯著提升；發生子宮外孕、減胎、卵巢過度刺激臨床症候群發生率，則在立法後顯著下降。多變項分析上，在著床為胚囊、臨床懷孕，以及成功誕下活產嬰兒上，立法後較立法前勝算顯著增加31-35%；減胎立法後勝算顯著則降低20%。發現相較於單胚胎植入，選擇植入兩個胚胎活產勝算可顯著增加11%。但若植入3顆或4顆胚胎，則可能同時增加活產與死產勝算。結論：本研究為台灣首篇比較施行胚胎植入限制的前後五年的試管嬰兒生殖結果的差異。研究發現法令限制植入胚胎後，試管嬰兒的活產機率增加及減胎機率減少，相關原因有待後續研究。綜整本研究發現與國內其它實證結果，建議台灣可再下修胚胎植入指引。政府更應持續發展人工生殖技術並擴大補助，特別是單胚胎之植入。

Objectives: To compare the outcomes of in vitro fertilisation (IVF) treatment before and after the 2007 IVF regulations in Taiwan by accessing data from the national assisted reproduction database. Methods: Clinical pregnancies (those with the foetal heartbeat detected), live births, miscarriage, fetal reduction, and ectopic pregnancy in the five years before and after the assisted reproduction act were assessed from the national assisted reproduction database. Analysis of variance, Chi-square test, and multivariate logistic regression of the generalized linear model were used to compare the outcomes before and after the implementation of the legislation. Results: A total of 83,264 IVF cycles performed between 2002 and 2012 were included in our analysis. After implementing the legislation, fewer embryos were transferred in IVF cycles, but higher percentages of gestational sacs, clinical pregnancies, and live births were achieved. The rates of miscarriages, ectopic pregnancy, and fetal reduction were significantly less in the post-legislation period than in the pre-legislation period. The multivariate analysis found that the odds of embryos reaching the gestational sacs, clinical pregnancies, and live births per cycle significantly increased by 31-35%; the odds of fetal reduction were decreased by 20%. Compared to single embryo transfer, double embryo transfer increases the odds of live births by 11%. Conclusions: This was the first study to focus on the reproductive outcomes of IVF in the five years before and after the legislation of the assisted reproduction act in Taiwan. The Assisted Reproduction Act limited the number of embryo transfers to four would increase the likelihood of live births and reduce the probability of fetal reduction, and there was still a need for further research to prove. We suggest that the legislation be revised to reduce the maximum number of embryo transfers in an IVF cycle from four to less based on our findings and previous studies. The government can encourage the development of IVF technology and deregulate medical allowances for every IVF cycle to promote fertility in Taiwan.

1. 吳嘉苓, CL,雷文玫, WM,鄧宗業, CY,謝新誼, HY(2017)。人工協助生殖科技的資料登錄與健康監測：跨國比較研究。台灣衛誌，36，6-20。
   連結：
2. Central Intelligence Agency. The world factbook. Total fertility rate. Available at: https://www.cia.gov/the-world-factbook/field/total-fertility-rate/countrycomparison. Accessed July 8, 2021.
3. Chang, HY,Hwu, WL,Chen, CH,Hou, CY,Cheng, W(2020).Children conceived by assisted reproductive technology prone to low birth weight, preterm birth, and birth defects: a cohort review of more than 50,000 live births during 2011-2017 in Taiwan.Front Pediatr,87,87.
4. Committee of the Society for Assisted Reproductive Technology(2017).Guidance on the limits to the number of embryos to transfer: a committee opinion.Fertil Steril,107,901-903.
5. Dyer, S,Chambers, G,de Mouzon, KJ(2016).International committee for monitoring assisted reproductive technologies world report: assisted reproductive technology 2008, 2009 and 2010.Hum Reprod,31,1588-1609.
6. Fedorcsák, P,Storeng, R,Dale, PO,Tanbo, T,Åbyholm, T(2000).Obesity is a risk factor for early pregnancy loss after IVF or ICSI.Acta Obstet Gynecol Scand,79,43-48.
7. Kasius, A,Smit, JG,Torrance, HL(2014).Endometrial thickness and pregnancy rates after IVF: a systematic review and meta-analysis.Hum Reprod Update,20,530-541.
8. Kutlu, P,Atvar, O,Vanlioglu, OF(2011).Effect of the new legislation and single-embryo transfer policy in Turkey on assisted reproduction outcomes: preliminary results.Reprod Biomed Online,22,208-214.
9. La Sala, GB,Gallinelli, A,Nicoli, A,Villani, MT,Nucera, G(2006).Pregnancy loss and assisted reproduction: preliminary results after the law 40/2004 in Italy.Reprod Biomed Online,13,65-70.
10. La Sala, GB,Villani, MT,Nicoli, A,Valli, B,Iannotti, F,Blickstein, I(2008).The effect of legislation on outcomes of assisted reproduction technology: lessons from the 2004 Italian law.Fertil Steril,89,854-859.
11. Malizia, BA,Hacker, MR,Penzias, AS(2009).Cumulative live-birth rates after in vitro fertilization.New Engl J Med,360,236-243.
12. Malizia, BA,Hacker, MR,Penzias, SA(2009).Cumulative live-birth rates after in vitro fertilization.N Engl J Med,360,236-243.
13. Mascarenhas, MN,Flaxman, SR,Boerma, T,Vanderpoel, S,Stevens, GA(2012).National, regional, and global trends in infertility prevalence since 1990: a systematic analysis of 277 health surveys.PLoS Med,9,e1001356.
14. MRC Working Party on Children Conceived by In Vitro Fertilisation(1990).Births in Great Britain resulting from assisted conception, 1978-87.BMJ,300,1229-1233.
15. Rhenman, A,Berglund, L,Brodin, T,Olovsson, M,Milton, K,Hadziosmanovic, N,Holte, J(2015).Which set of embryo variables is most predictive for live birth? A prospective study in 6,252 single embryo transfers to construct an embryo score for the ranking and selection of embryos.Hum Reprod,30,28-36.
16. Richter, KS,Bugge, KR,Bromer, JG,Levy, MJ(2007).Relationship between endometrial thickness and embryo implantation, based on 1,294 cycles of in vitro fertilization with transfer of two blastocyst-stage embryos.Fertil Steril,87,53-59.
17. Schieve, LA,Peterson, HB,Meikle, SF(1999).Livebirth rates and multiple-birth risk using in vitro fertilization.JAMA,282,1832-1838.
18. Steward, RG,Lan, L,Shah, AA(2014).Oocyte number as a predictor for ovarian hyperstimulation syndrome and live birth: an analysis of 256,381 in vitro fertilization cycles.Fertil Steril,101,967-973.
19. Wu, CL,Ha, JO,Tsuge, A(2020).Data reporting as care infrastructure: assembling ART registries in Japan, Taiwan, and South Korea.East Asian Sci Technol Soc,14,35-59.
20. Yu, HC,Rei, WM,Chiou, ST,Deng, CY(2021).Multivariate analysis of the factors associated with live births during in vitro fertilisation in Southeast Asia: a crosssectional study of 104,015 in vitro fertilisation records in Taiwan.J Assist Reprod Genet,38,2415-2423.
21. 內政部戶政司：出生數及粗出生率(按登記及發生)。https://www.ris.gov.tw/app/portal/346。引用2021/07/08。 Department of Household Registration, Ministry of the Interior, R.O.C. (Taiwan). Number of births and crude birth rate (by registration and occurrence time). Available at: https://www.ris.gov.tw/app/portal/346. Accessed July 8, 2021. [In Chinese]
22. 台灣生殖醫學會：台灣生殖醫學會胚胎植入數指引2016。http://www.tsrm.org.tw/DB/News/file/39/105.pdf。引用2021/07/08。 Taiwanese Society for Reproductive Medicine (TSRM). TSRM guideline of recommended limits of the number of embryos to transfer. Available at: http://www.tsrm.org.tw/DB/News/file/39/105.pdf. Accessed July 8, 2021. [In Chinese]
23. 吳品潔, PC,潘湘如, HJ(2014)。男性不孕症。家庭醫學與基層醫療，29，284-289。
24. 衛生福利部國民健康署：民國94年台灣地區人工協助生殖施行結果分析報告。台北：衛生福利部國民健康署，2007。 Health Promotion Administration, Ministry of Health and Welfare, R.O.C. (Taiwan). The Assisted Reproductive Technology Summary 2005 National Report of Taiwan. Taipei: Health Promotion Administration, Ministry of Health and Welfare, R.O.C. (Taiwan), 2007. [In Chinese]
25. 衛生福利部國民健康署：民國107年台灣地區人工協助生殖施行結果分析報告。台北：衛生福利部國民健康署，2020。 Health Promotion Administration, Ministry of Health and Welfare, R.O.C. (Taiwan). The Assisted Reproductive Technology Summary 2018 National Report of Taiwan. Taipei: Health Promotion Administration, Ministry of Health and Welfare, R.O.C. (Taiwan), 2020. [In Chinese]
26. 衛生福利部衛生福利資料科學中心, Ministry of Health and Welfare, R.O.C. (Taiwan)。衛生福利部衛生福利資料科學中心：人工生殖資料庫。https://www.mohw.gov.tw/。引用2021/07/08。 Health and Welfare Data Science Center, Ministry of Health and Welfare, R.O.C. (Taiwan). Artificial reproductive data. Available at: https://www.mohw.gov.tw/. Accessed July 8, 2021. [In Chinese]。https://www.mohw.gov.tw/