Safety issues in assisted reproduction technology
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Obstétrique et gynécologie Faculté de médecine Safety issues in assisted reproduction technologyThe children of assisted reproduction confront the responsible conduct of assisted reproductive technologies R D Lambert, Laval University, Québec, Canada M J Mélançon, University of Québec, Chicoutimi, Canada Unité de bioéthique Sciences humaines
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Safety issues in assisted reproduction technology Background Multiple pregnancies Data Regulations Singleton pregnancies Data Etiology of the risks Discussion Evolution of the knowledge regarding the IVF babies’ health Evolution of ethics within time The responsible conduct of ARTs Conclusion
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Safety issues in assisted reproduction technology Background: - The incidence of multiple pregnancies has risen significantly over the past few decades. Ovarian stimulation (OS) and the transfer of multiple in vitro fertilized embryos (IVF) are mainly responsible for this increase. - Singleton pregnancies from infertility treatment are also at risks.
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Multiple pregnancies. Data Multiple pregnancies: correlate with prematurity, intra-uterine growth retardation, low birth weight, perinatal mortality and morbidity, and impaired child and woman health.
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Multiple pregnancies. DataNumber of children born alive after an IVF or an ovarian stimulation in Canada and USA OS: Ovarian stimulation
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Multiple pregnancies. DataFrequency of health problems in IVF babies and in the general population
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Multiple pregnancies. DataFrequency of health problems in twins and triplets conceived spontaneously or through IVF
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Multiple pregnancies. DataEstimation of the number of babies born with health problems from iatrogenic multiple pregnancies in 2002 in Canada
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Multiple pregnancies. DataEstimation of the number of babies born with health problems from iatrogenic multiple pregnancies in 2002 in USA
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Multiple pregnancies. Regulations These health problems in children born from ARTs are often a tragedy for families. It challenges the responsible practice of medicine (for more information, see: http://www.cours.fmed.ulaval.ca/a05/eth64841en/table-of-contents/ ). It raises the question of regulation of ARTs. Accordingly, there should be a great concern about these problems in the medical and the scientific communities.* *: States, ministries of health and legislators should also be concerned (Lambert and Mélançon (2007). L'Observatoire de la génétique No 34. http://www.ircm.qc.ca/bioethique/obsgenetique/).
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Multiple pregnancies. Regulations The core values of medicine Traditionally, the goals of medicine have been: - To preserve and extent life; - To promote and maintain health; - To relieve pain and suffering. The Declaration of Helsinki (Article 2) is explicitly clear in this effect: “It is the duty of the physician to promote and safeguard the health of the people. The physician’s knowledge and conscience are dedicated to the fulfillment of this duty.”
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Multiple pregnancies. Regulations Ethical principles The respect of human dignity is a moral imperative that translates into a number of important correlative ethical principles directly related to the question of promotion of health. It is the duty of the physicians to avoid, prevent, or minimize any harm that could be done to their patients. Physicians must ensure that patient consent is informed and not coerced.
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Multiple pregnancies. Regulations Decision making process The ethical decision making process involves the couple’s choice*, the physician’s duty**, and the infant’s health***, and must also take into account the biomedical data****. *Principle of autonomy. **Professional deontology. ***Principle of beneficience. ****Declaration of Helsinki.
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Multiple pregnancies. Regulations Medical guidelines In order to minimize health problems resulting from the transfer of multiple IVF embryos, some professional associations have proposed new guidelines based on the goals of medicine and the respect of human dignity. Because the goal of infertility treatment is to aid prospective parents—as much as possible and with the least harm—in achieving their desire to have children, the general view of the ESHRE (2001) is that gynaecologists should always aim for singleton pregnancies.
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Multiple pregnancies. Regulations Medical guidelines The ESHRE Campus Report on prevention of twin pregnancies after IVF/ICSI: “Common sense dictates that elective SET ... should be applied from now onward… should be recommended without further delay if at least two conditions are fulfilled: 1) The patient is twin prone. This definition needs to be further fine-tuned in well-designed clinical studies, but currently includes: age (definitely if <34; probably if <38 years of age) and rank of trial (first trial, probably second trial as well); 2) If a “top-quality embryo” can be transferred.”
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Multiple pregnancies. Regulations Medical guidelines Some medical associations suggest that producing healthy singleton births should be the main objective of an IVF centre: “The long-term welfare of the family should take precedence over the short term goal of achieving a pregnancy and ambiguous preoccupation with success figures. Indeed, a healthy child is the ultimate goal of IVF-treatment… the professional competence of an IVF centre should be measured in terms of ongoing singleton pregnancies per cycle.” (ESHRE, 2001).
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Multiple pregnancies. Regulations Medical guidelines The couple should be thoroughly informed of the risks of multiple gestation in cases where more than one embryo is transferred (ESHRE, 2000). Once informed of the obstetrical and neonatal risks, couples can be easily persuaded to opt for transfer of two embryos, and patients with good prognoses can be advised to accept transfer of a single embryo (Coetsier & Dhont, 1998).
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Multiple pregnancies. Regulations Given that it would be possible to avoid most of these iatrogenic multiple pregnancies from OS by performing an adequate periovulatory monitoring, by cancelling the cycle, by converting it to an IVF cycle, or by selective follicular aspiration, the respect of the infant must prevail over any other considerations.* * Principles of beneficience and non-maleficience.
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Singleton pregnancies: Singleton ARTs babies have a greater risk of cerebral palsy, premature birth, low and very low birth weights, and/or multiple birth defects [Hansen, 2002; Koivurova, 2002; Schieve, 2002; Strömberg, 2002; Kozinszky, 2003; Helmerhorst, 2004; Jackson, 2004; Kurinczuk, 2004; Poikkeus, 2007]. These risks are grossly two-three times higher in ARTs singleton babies as compared to naturally conceived singleton babies and are costly for the child, the family and the society. Safety issues in assisted reproduction technology
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Singleton pregnancies. Data After adjustment for confounding factors, Laura Schieve et al (1) have shown that singletons born after ART are at higher risk for adverse perinatal outcomes (LBW: 62%; VLBW: 79%; preterm delivery: 41%; preterm LBW: 74%; term LBW: 39%. Term LBW declined from 1996-2000 whereas preterm was stable). A meta-analysis by Michèle Hansen et al (2) confirmed that singletons born from ART are at increased risk (30-40%) of adverse perinatal outcome. VLBW infants born from IVF are not are higher risk for mortality and morbidity than naturally conceived VLBW infants (3). Thus the frequency of VLBW is the issue. After adjustment for confounding factors, congenital malformations are 40% higher in babies born after ICSI, IVF, IUI, or OS than in babies conceived in less than 12 months, without infertility treatment, while babies born after spontaneous conception in subfertile couples (infertility = 12 months) are 20% more at risks than babies conceived in less than 12 months (4). Schieve et al (2004). Obstet Gynecol 103:1144-53. Hansen et al (2005). Hum Reprod 20 (2):328-338. (n=25 studies, including 7 selected studies whose design, methods, birth defects definition and adjustment for confounders were considered adequate) Schimmel et al (2006) Fertil Steril 85 (4):907-12 Zhu et al (2006). Br Med J doi:10.116/bmj.33819.AE
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Singleton pregnancies. Data
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Singleton pregnancies. Data Adverse perinatal outcomes in ARTs singletons are not fully understood. What is the origin of such risks? No clear answer for the moment. Infertile status of the couple? Medication for ovarian stimulation? In vitro culture?
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Singleton pregnancies. Etiology of the risks Infertile status of the couple: slightly reduced risks for babies born from couples where the male is clearly responsible for the infertility (1). A four fold increase in LBW was observed when the partner's semen (female factor) instead of a donor semen (male factor) was used for insemination (2). Pregnancy outcome is not different between singleton IVF babies and singleton intra-uterine inseminated babies (3) Congenital malformations are 20% higher in babies born after spontaneous conception in subfertile couples (infertility = 12 months) than babies conceived in less than 12 months (4). Schieve et al (2004). Obstet Gynecol 103:1144-53 Gaudoin et al (2003). Am J Ob Gyn 188(3):611-6 De Sutter et al (2005). Hum Reprod 20(6):1642-6 Zhu et al (2006). Br Med J doi:10.116/bmj.33819.AE
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Singleton pregnancies. Etiology of the risks Medication for ovarian stimulation: The use of ovarian stimulation is not associated with low birth weight when intra-uterine insemination using donor semen is performed (male factor). However, a four fold increase was observed when the partner's semen (female factor) was inseminated (1), thus suggesting that that low birth weight results mainly from factors other than medication. 1) Gaudoin et al., 2003. Am J Ob Gyn 188(3):611-6
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Singleton pregnancies. Etiology of the risks The in vitro procedure: Babies born from AI women with known female factor or born from IVF are at equivalent risk (1) which may suggest that the in vitro procedure do not contribute to the health problems in IVF babies. However, risks in the male factor subset were still elevated in the Laura Schieve study in comparison with the general population (2), thus suggesting that, in addition to the infertility factor, other factors may explain the health risks for ARTs babies. Nuojua-Huttunen et al (1999). Hum Reprod 14:2110-5 Schieve et al (2004). Obstet Gynecol 103:1144-53
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Safety issues in assisted reproduction technology. Discussion Evolution of the knowledge regarding the IVF babies’ health: Transfer of several embryos = multiple gestation = health problems Health risks for singleton IVF babies are known since 2002
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Evolution of the knowledge regarding the IVF babies’ health Transfer of several embryos = multiple gestation Research on laboratory and domestic animals and the practices of embryo transfer in veterinary medicine has shown that multiple embryo transfer resulted in multiple gestation. This correlation was demonstrated a long time ago and was well known by the time of the birth of the first test-tube baby (Lambert, 2002. 17(12):3011-15).
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Evolution of the knowledge regarding the IVF babies’ health Multiple gestation = health problems At the birth of the first test tube baby in 1978, the medical risks of multiple gestations had already been documented. Soon after the introduction of ART, multiple gestations resulting from the transfer of IVF embryos were acknowledged (Lambert, 2002. Hum Reprod 17(12):3011-15).
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Evolution of the knowledge regarding the IVF babies’ health Transfer of several embryos = multiple gestation = health problems Everyone in the field had access to these data, and restricting the number of embryos transferred after IVF was proposed as soon as 1983 (Lambert, 2002. Hum Reprod 17(12):3011-15).
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Evolution of the knowledge regarding the IVF babies’ health Singleton IVF babies are at risk for some specific health problems. Now that these risks are well known (since 2002), a responsible clinician has to try to avoid them in his practice.
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Evolution of ethics within time Medical practices should evolve with the knowledge, as well as guidelines and ethics : What is ethically acceptable at a given time may become inacceptable at some later time.
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The responsible conduct of ARTs The clinician is the only health professional able to assess the risks related to the use of ART (1). In some circumstances, he may be confronted to infertile couples who want a child at any cost (1). In the case of a conflict between the couple’s automomy and the clinician’s responsibility, the interest of the child must prevail (1). 1) (Mélançon and Lambert (2004). Internatl Congress Series 1271:349-52).
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The responsible conduct of ARTs The health of the future child is at the heart of the clinical decision making. The right OF the child to health prevails over the right TO a child, since it is the latter who will have to assume the health conditions made for him.
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The responsible conduct of ARTs Let us be clear: a given couple may choose the level of risks they are willing to assume when it is a matter of their own health. But within the context of ARTs, a third party is involved: the future child who must be considered as vulnerable. Protection of the vulnerable is a matter of the physician’s moral, as well as deontological, responsibility. Consequently, responsibility toward the future generation calls for an ethics of risk prevention when the health risks are known.
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Safety issues in assisted reproduction technology Conclusion 1. We dissent from the following opinion: « Don’t patients have the right to choose different risk levels, based on their own, private circumstances and desires? Isn’t it patronizing to assume that well educated adults are incapable of making such decisions in a personal and responsible way? » Gleicher N. Safety issues in assisted reproduction technology. A rebuttal. Hum reprod 2003; 18(9):1765-1766.
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Safety issues in assisted reproduction technology Conclusion 2. The transfer of several embryos should be avoided in most cases, even if it is the couple’s choice, given the risks for the babies.
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Safety issues in assisted reproduction technology Conclusion 3. Protection of the vulnerable is the physician’s responsibility.
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Safety issues in assisted reproduction technology Conclusion 4. The advisability of offering a therapy should always be evaluated in light of the best interest of the future offspring.
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