safety issues in assisted reproduction technology safety issues in assisted reproduction technology
TRANSCRIPT
Obstétrique et gynécologieFaculté de médecine
Safety issues in assisted reproduction technology
The 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 bioéthiqueSciences humaines
Safety issues in assisted reproduction technology
BackgroundBackgroundMultiple pregnanciesMultiple pregnancies– DataData– RegulationsRegulations
Singleton pregnanciesSingleton pregnancies– DataData– Etiology of the risksEtiology of the risks
DiscussionDiscussion– Evolution of the knowledge regarding the IVF babies’ healthEvolution of the knowledge regarding the IVF babies’ health– Evolution of ethics within timeEvolution of ethics within time– The responsible conduct of ARTsThe responsible conduct of ARTs
ConclusionConclusion
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.
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.
Multiple pregnancies. DataNumber of children born alive after an IVF or an ovarian
stimulation in Canada and USA
Canada (2002)Canada (2002) USA (2000)USA (2000)
9 5619 561 126 325126 325
IVF/ICSI: ≥2155 babiesIVF/ICSI: ≥2155 babies OSOS IVF/ICSI: 35 025 babiesIVF/ICSI: 35 025 babies OSOS
Single-Single-tonstons
TwinsTwins Triplets Triplets & +& +
Twins Twins & +& +
Single-Single-tonstons
TwinsTwins Triplets Triplets & +& +
Twins & Twins & ++
1014 1014 (47%)(47%)
994 994 (46%)(46%)
≥≥147 147 (7%)(7%)
≈≈2 094 2 094 ((≈≈21.9%)21.9%)
16 422 16 422 (46.9%)(46.9%)
15 411 15 411 (44%)(44%)
3 192 3 192 (≈9%)(≈9%)
27 665 27 665 (21.9%)(21.9%)
OS: Ovarian stimulation
Multiple pregnancies. DataFrequency of health problems in IVF babies and in the general population
PathologyPathology Whole populationWhole population All IVF babiesAll IVF babies
Cerebral palsyCerebral palsy11 0.15%0.15% 0.55%0.55%
Prematurity (<32)Prematurity (<32)22 1.1%1.1% 5.3%5.3%
Prematurity (<37)Prematurity (<37)2,32,3 7-7.8%7-7.8% 31-32%31-32%
Low birth weight (Low birth weight (<2500g)<2500g)2,3,42,3,4 4.6-7.3%4.6-7.3% 13-30%13-30%
Very low birth weight Very low birth weight (<1500g)(<1500g)2,3,42,3,4
0.9-1.4%0.9-1.4% 2.6-8%2.6-8%
Multiple birth defectsMultiple birth defects1,31,3 8.9-14%8.9-14% 0.39-6.6%0.39-6.6%
Néonatal mortalityNéonatal mortality3,53,5 8.9-14%8.9-14% 16-28%16-28%
Child dveloppementChild dveloppement11 0.1%0.1% 0.39%0.39%
RetinoblastomaRetinoblastoma66 0.006%0.006% 0.03-.04%0.03-.04%
Beckwith-Wiedemann Beckwith-Wiedemann SyndromeSyndrome7,87,8
0.0033%0.0033% 0.014%0.014%
%: frequency among all pregnancies. %: frequency among all pregnancies. 1) Stromberg et al (2002). Lancet 359:461-5. 2) Hansen et al (2002). NEJM 346(10):725-30. 3) Koivurova et al 1) Stromberg et al (2002). Lancet 359:461-5. 2) Hansen et al (2002). NEJM 346(10):725-30. 3) Koivurova et al (2002). Hum Reprod 17(5):1391-8. 4) Schieve et al (2002). NEJM 346(10):731-7. 5) Olivennes et al (2002). Hum Reprod Update 8(2):117-28.(2002). Hum Reprod 17(5):1391-8. 4) Schieve et al (2002). NEJM 346(10):731-7. 5) Olivennes et al (2002). Hum Reprod Update 8(2):117-28. 6) 6) Calculated from Moll et al (2003). Lancet 361:309-10. Suggestive data from multiple and single pregnancies.Calculated from Moll et al (2003). Lancet 361:309-10. Suggestive data from multiple and single pregnancies. 7) 7) Calculated from Maher et al (2003). J Med Calculated from Maher et al (2003). J Med Genet 40:62-4. Suggestive data from multiple and single pregnancies. 8) DeBaun et al (2003). Am J Hum Genet 72:156-60. Suggestive data from multiple Genet 40:62-4. Suggestive data from multiple and single pregnancies. 8) DeBaun et al (2003). Am J Hum Genet 72:156-60. Suggestive data from multiple
and single pregnancies.and single pregnancies.
Multiple pregnancies. DataFrequency of health problems in twins and triplets conceived
spontaneously or through IVF
PathologyPathology TwinsTwins11 TwinsTwins22 IVFIVF33
SpontaSpontaneousneous
IVFIVF SpontaSpontaneousneous
IVFIVF SingleSingletonstons
TwinsTwins TripletsTriplets
Cerebral palsyCerebral palsy 0.3%0.3% 0.4%0.4%
Prematurity (<32)Prematurity (<32) - France- France - USA- USA
7.1%7.1% 6.8%6.8%1.6%1.6%1.7%1.7%
7.8%7.8%13.9%13.9%
28.4%28.4%41.3%41.3%
Low birth weight Low birth weight ((<1500g)<1500g) - France- France - USA - USA
3.8-3.8-10.4%10.4%
5-25%5-25%
1.2%1.2%1.1%1.1%
5.4%5.4%10.1%10.1%
23.5%23.5%31.9%31.9%
Neonatal mortalityNeonatal mortality 43.3%43.3% 23%23% 15.4%15.4% 10.6%10.6% 7.6%7.6% 20.8%20.8% 39.5%39.5%
Child developmentChild development 0.6%0.6% 0.6%0.6%%: frequency among all pregnancies. %: frequency among all pregnancies.
1) 1) Helmerhorst Helmerhorst et al (2004). « Matched studies only. 2) et al (2004). « Matched studies only. 2) Pinborg Pinborg et al (2004). NEJM 346(10):725-30. 3) et al (2004). NEJM 346(10):725-30. 3) Nowak Nowak et al (2003). Tables I, II and IVet al (2003). Tables I, II and IV..
Multiple pregnancies. DataEstimation of the number of babies born with health problems from
iatrogenic multiple pregnancies in 2002 in Canada
PathologyPathology IVF twinsIVF twins11 IVF tripletsIVF triplets33 Twins & + OSTwins & + OS IVF + OSIVF + OS
Selected Selected frequen-frequen-
cycy22
AffectedAffectedinfantsinfants
Selected Selected frequen-frequen-
cycy44
AffectedAffectedinfantsinfants
Selected Selected frequen-frequen-
cycy22
AffectedAffectedinfantsinfants
Total Total number in number in
excessexcess
Cerebral Cerebral palsypalsy
0.4%0.4% 4 (1.5)4 (1.5) ------ ------ 0.4%0.4% 8 (3)8 (3) 77
Prematurity Prematurity (<32 weeks)(<32 weeks)
6.8%6.8% 68 (11)68 (11) 41.3%41.3% 61 (1.6)61 (1.6) 6.8%6.8% 143 (23)143 (23) 236236
Very low Very low birth weight*birth weight*
5%5% 50 (9)50 (9) 31.9%31.9% 47 (1.3)47 (1.3) 5%5% 105 (19)105 (19) 173173
Neonatal Neonatal mortality mortality
10.6%10.6% 105 (88)105 (88) 39.5%39.5% 58 (13)58 (13) 10.6%10.6% 222 222 (186)(186)
9898
Child Child development development
0.6%0.6% 6 (1)6 (1) ------ ------ 0.6%0.6% 13 (2)13 (2) 1616
%: %: frequency among all pregnancies. *: frequency among all pregnancies. *: <1500g.<1500g.1: n=994, see slide No 4; 2: The lowest frequency as reported in the previous slide; 3: n=147, see slide No 4; 4: 1: n=994, see slide No 4; 2: The lowest frequency as reported in the previous slide; 3: n=147, see slide No 4; 4: Nowak Nowak et alet al., (2003); (): No of infants who would have been affected if the incidence had been the same as in the whole ., (2003); (): No of infants who would have been affected if the incidence had been the same as in the whole population (slide No 5)population (slide No 5)
Multiple pregnancies. DataEstimation of the number of babies born with health problems from
iatrogenic multiple pregnancies in 2002 in USA
PathologyPathology IVF twinsIVF twins11 IVF tripletsIVF triplets33 Twins & + OSTwins & + OS IVF + OSIVF + OS
Selected Selected frequen-frequen-
cycy22
AffectedAffectedinfantsinfants
Selected Selected frequen-frequen-
cycy44
AffectedAffectedinfantsinfants77
Selected Selected frequen-frequen-
cycy22
AffectedAffectedinfantsinfants
Total Total number in number in
excessexcess
Cerebral Cerebral palsypalsy
0.4%0.4% 62 (23)62 (23) ------ ------ 0.4%0.4% 111 (42)111 (42) 107107
Prematurity Prematurity (<32)(<32)11
6.8%6.8% 1048 1048 (170)(170)
41.3%41.3% 1302 1302 (35)(35)
6.8%6.8% 1881 1881 (304)(304)
37223722
Very low Very low birth weight*birth weight*
5%5% 771 771 (139)(139)
31.9%31.9% 1005 1005 (28)(28)
5%5% 1383 1383 (249)(249)
27432743
Neonatal Neonatal mortality mortality
10.6%10.6% 1634 1634 (1372)(1372)
39.5%39.5% 1245 1245 (281)(281)
10.6%10.6% 2932 2932 (2462)(2462)
16961696
Child Child development development
0.6%0.6% 92 (15)92 (15) ------ ------ 0.6%0.6% 166 (28)166 (28) 215215
%: %: frequency among all pregnancies. *: frequency among all pregnancies. *: <1500g.<1500g.1: n=15 411, see slide No 4; 2: The lowest frequency as reported in the previous slide; 3: n=3 192, see slide No 4; 4: 1: n=15 411, see slide No 4; 2: The lowest frequency as reported in the previous slide; 3: n=3 192, see slide No 4; 4: Nowak Nowak et alet al., (2003); (): No of infants who would have been affected if the incidence had been the same as in the whole ., (2003); (): No of infants who would have been affected if the incidence had been the same as in the whole population (slide No 5)population (slide No 5)
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/).
Multiple pregnancies. Regulations
The core values of medicineTraditionally, 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.”
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.
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.
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.
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.”
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).
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).
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.
Singleton pregnancies: Singleton ARTs babies have a greater risk of cerebral cerebral
palsy, premature birth, low and very low birth weights, palsy, premature birth, low and very low birth weights, and/or multiple birth defects [Hansen, 2002; Koivurova, and/or multiple birth defects [Hansen, 2002; Koivurova, 2002; Schieve, 2002; Strömberg, 2002; Kozinszky, 2002; Schieve, 2002; Strömberg, 2002; Kozinszky, 2003; Helmerhorst, 2004; Jackson, 2004; Kurinczuk, 2003; Helmerhorst, 2004; Jackson, 2004; Kurinczuk, 2004; Poikkeus, 2007]. These risks are grossly two-2004; Poikkeus, 2007]. These risks are grossly two-three times higher in ARTs singleton babies as three times higher in ARTs singleton babies as compared to naturally conceived singleton babies and compared to naturally conceived singleton babies and are costly for the child, the family and the society.are costly for the child, the family and the society.
Safety issues in assisted reproduction technology
Singleton pregnancies. Data
After adjustment for confounding factors, Laura Schieve et al (1) have After adjustment for confounding factors, Laura Schieve et al (1) have shown that singletons born after ART are at higher risk for adverse perinatal shown that singletons born after ART are at higher risk for adverse perinatal outcomes outcomes (LBW: 62%; VLBW: 79%; preterm delivery: 41%; preterm LBW: 74%; term LBW: 39%. Term LBW (LBW: 62%; VLBW: 79%; preterm delivery: 41%; preterm LBW: 74%; term LBW: 39%. Term LBW declined from 1996-2000 whereas preterm was stable).declined from 1996-2000 whereas preterm was stable).
A meta-analysis by Michèle Hansen et al (2) confirmed that singletons born 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.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 VLBW infants born from IVF are not are higher risk for mortality and morbidity than naturally conceived VLBW infants (3). Thus the morbidity than naturally conceived VLBW infants (3). Thus the frequency of frequency of VLBWVLBW is the issue. is the issue.After adjustment for confounding factors, congenital malformations are 40% After adjustment for confounding factors, congenital malformations are 40% higher in babies born after ICSI, IVF, IUI, or OS than in babies higher in babies born after ICSI, IVF, IUI, or OS than in babies conceived in conceived in less than 12 months, without infertility treatment, while babies less than 12 months, without infertility treatment, while babies born after born after spontaneous conception in subfertile couples (infertility spontaneous conception in subfertile couples (infertility ≥ 12 months) are ≥ 12 months) are 20% more at risks than babies conceived in less than 12 months (4). 20% more at risks than babies conceived in less than 12 months (4).
1)1) Schieve et al (2004). Obstet Gynecol 103:1144-53.Schieve et al (2004). Obstet Gynecol 103:1144-53.2)2) Hansen et al (2005). Hum Reprod 20 (2):328-338. (n=25 studies, including 7 selected studies whose design, 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)methods, birth defects definition and adjustment for confounders were considered adequate)3)3) Schimmel et al (2006) Fertil Steril 85 (4):907-12Schimmel et al (2006) Fertil Steril 85 (4):907-124)4) Zhu et al (2006). Br Med J doi:10.116/bmj.33819.AEZhu et al (2006). Br Med J doi:10.116/bmj.33819.AE
Singleton pregnancies. DataHealth problemsHealth problems Incidence and risks*Incidence and risks*
General populationGeneral population IVFIVF RiskRisk
Cerebral palsyCerebral palsy 0.140.1422 0.380.3822 2.82.822
Prematurity ≤ 37 semPrematurity ≤ 37 sem 5.85.833
5.65.644
12.512.533
8.68.644
2.22.233
1.51.544
Prematurity ≤ 32 semPrematurity ≤ 32 sem 1.11.144
0.70.755
2244
1.11.155
1.81.844
1.61.655
LBWLBW 7.37.311
4.24.233
2.52.544
13.213.211
7733
4.04.044
1.81.811
1.71.733
1.61.644
VLBWVLBW 1.41.411
1.11.133
0.70.744
0.60.655
2.62.611
3333
2.02.0 4 4
1.11.155
1.81.811
2.72.733
2.82.844
1.81.855
Birth defectsBirth defects 0.160.1622
4.24.233
0.350.3522
9.59.533
2.22.222
2.32.333
Growth retardationGrowth retardation 0.090.0922 0.190.1922 2222
**: % of all pregnancies; : % of all pregnancies; 1: Schieve 1: Schieve et alet al., 2002; 2: Strömberg ., 2002; 2: Strömberg et alet al., 2002; 3: Hansen ., 2002; 3: Hansen et alet al., 2002; 4: Koivurova ., 2002; 4: Koivurova et alet al., 2002; Poikkeus ., 2002; Poikkeus et alet al., 2007., 2007
Singleton pregnancies. Data
Adverse perinatal outcomes in ARTs Adverse perinatal outcomes in ARTs singletons are not fully understood. singletons are not fully understood.
What is the origin of such risks? No clear What is the origin of such risks? No clear answer for the moment.answer for the moment.– Infertile status of the couple? Infertile status of the couple? – Medication for ovarian stimulation?Medication for ovarian stimulation?– In vitro culture?In vitro culture?
Singleton pregnancies. Etiology of the risks
Infertile status of the coupleInfertile status of the couple:: slightly reduced risks for babies born from couples where the male slightly reduced risks for babies born from couples where the male is clearly responsible for the infertility (1).is clearly responsible for the infertility (1).A four fold increase in LBW was observed when the partner's A four fold increase in LBW was observed when the partner's semen (female factor) instead of a donor semen (male factor) was semen (female factor) instead of a donor semen (male factor) was used for insemination (2).used for insemination (2).Pregnancy outcome is not different between singleton IVF babies Pregnancy outcome is not different between singleton IVF babies and singleton intra-uterine inseminated babies (3)and singleton intra-uterine inseminated babies (3)Congenital malformations are 20% higher in babies born after Congenital malformations are 20% higher in babies born after spontaneous conception in subfertile couples (infertility spontaneous conception in subfertile couples (infertility ≥ 12 ≥ 12 months) than babies conceived in less than 12 months (4).months) than babies conceived in less than 12 months (4).
1)1) Schieve et al (2004). Obstet Gynecol 103:1144-53Schieve et al (2004). Obstet Gynecol 103:1144-532)2) Gaudoin et al (2003). Am J Ob Gyn 188(3):611-6Gaudoin et al (2003). Am J Ob Gyn 188(3):611-63)3) De Sutter et al (2005). Hum Reprod 20(6):1642-6De Sutter et al (2005). Hum Reprod 20(6):1642-64)4) Zhu et al (2006). Br Med J doi:10.116/bmj.33819.AEZhu et al (2006). Br Med J doi:10.116/bmj.33819.AE
Singleton pregnancies. Etiology of the risks
Medication for ovarian stimulationMedication for ovarian stimulation::The use of ovarian stimulation is not associated The use of ovarian stimulation is not associated with low birth weight when intra-uterine with low birth weight when intra-uterine insemination using donor semen is performed insemination using donor semen is performed (male factor). However, a four fold increase was (male factor). However, a four fold increase was observed when the partner's semen (female factor) observed when the partner's semen (female factor) was inseminated (1), thus suggesting that that low was inseminated (1), thus suggesting that that low birth weight results mainly from factors other than birth weight results mainly from factors other than medication.medication.
1)1) Gaudoin et al., 2003. Am J Ob Gyn 188(3):611-6Gaudoin et al., 2003. Am J Ob Gyn 188(3):611-6
Singleton pregnancies. Etiology of the risks
The in vitro procedureThe in vitro procedure::Babies born from AI women with known female Babies born from AI women with known female factor or born from IVF are at equivalent risk (1) factor or born from IVF are at equivalent risk (1) which may suggest that the in vitro procedure do which may suggest that the in vitro procedure do not contribute to the health problems in IVF babies.not contribute to the health problems in IVF babies.However, risks in the male factor subset were still However, risks in the male factor subset were still elevated in the Laura Schieve study in comparison elevated in the Laura Schieve study in comparison with the general population (2), thus suggesting with the general population (2), thus suggesting that, in addition to the infertility factor, other factors that, in addition to the infertility factor, other factors may explain the health risks for ARTs babies.may explain the health risks for ARTs babies.
1)1) Nuojua-Huttunen et al (1999). Hum Reprod 14:2110-5Nuojua-Huttunen et al (1999). Hum Reprod 14:2110-52)2) Schieve et al (2004). Obstet Gynecol 103:1144-53Schieve et al (2004). Obstet Gynecol 103:1144-53
Safety issues in assisted reproduction technology. Discussion
Evolution of the knowledge regarding the Evolution of the knowledge regarding the IVF babies’ health:IVF babies’ health:– Transfer of several embryos = multiple
gestation = health problems– Health risks for singleton IVF babies are
known since 2002
Evolution of the knowledge Evolution of the knowledge regarding the IVF babies’ healthregarding 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).
Evolution of the knowledge Evolution of the knowledge regarding the IVF babies’ healthregarding 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).
Evolution of the knowledge Evolution of the knowledge regarding the IVF babies’ healthregarding 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).
Evolution of the knowledge Evolution of the knowledge regarding the IVF babies’ healthregarding the IVF babies’ health
Singleton IVF babies are at risk for some Singleton IVF babies are at risk for some specific health problems.specific health problems.
Now that these risks are well known (since Now that these risks are well known (since 2002), a responsible clinician has to try to avoid 2002), a responsible clinician has to try to avoid them in his practice. them in his practice.
Evolution of ethics within timeEvolution of ethics within time
Medical practices should evolve with the Medical practices should evolve with the knowledge, as well as guidelines and knowledge, as well as guidelines and ethics : What is ethically acceptable at a ethics : What is ethically acceptable at a given time may become inacceptable at given time may become inacceptable at some later time.some later time.
The responsible conduct of ARTsThe responsible conduct of ARTs
The clinician is the only health professional able The clinician is the only health professional able to assess the risks related to the use of ART (1).to assess the risks related to the use of ART (1).
In some circumstances, he may be confronted to In some circumstances, he may be confronted to infertile couples who want a child at any cost (1).infertile couples who want a child at any cost (1).
In the case of a conflict between the couple’s In the case of a conflict between the couple’s automomy and the clinician’s responsibility, the automomy and the clinician’s responsibility, the interest of the child must prevail (1).interest of the child must prevail (1).
1) 1) (Mélan(Mélançon and Lambert (2004). Internatl Congress Series 1271:349-on and Lambert (2004). Internatl Congress Series 1271:349-52).52).
The responsible conduct of ARTsThe responsible conduct of ARTs
The health of the future child is at the The health of the future child is at the heart of the clinical decision making.heart of the clinical decision making.
The right OF the child to health prevails The right OF the child to health prevails over the right TO a child, since it is the over the right TO a child, since it is the latter who will have to assume the health latter who will have to assume the health conditions made for him.conditions made for him.
The responsible conduct of ARTsThe responsible conduct of ARTs
Let us be clear: a given couple may choose the level of Let us be clear: a given couple may choose the level of risks they are willing to assume when it is a matter of risks they are willing to assume when it is a matter of their own health. their own health.
But within the context of ARTs, a third party is involved: But within the context of ARTs, a third party is involved: the future child who must be considered as vulnerable.the future child who must be considered as vulnerable.
Protection of the vulnerable is a matter of the physician’s Protection of the vulnerable is a matter of the physician’s moral, as well as deontological, responsibility.moral, as well as deontological, responsibility.
Consequently, responsibility toward the future generation Consequently, responsibility toward the future generation calls for an ethics of risk prevention when the health calls for an ethics of risk prevention when the health risks are known.risks are known.
Safety issues in assisted reproduction technology
ConclusionConclusion
1. We dissent from the following opinion: 1. We dissent from the following opinion: « Don’t patients have the right to choose different « Don’t patients have the right to choose different risk levels, based on their own, private risk levels, based on their own, private
circumstances and desires? Isn’t it patronizing to circumstances and desires? Isn’t it patronizing to assume that well educated adults are incapable of assume that well educated adults are incapable of making such decisions in a personal and making such decisions in a personal and responsible way? »responsible way? »
Gleicher N. Safety issues in assisted reproduction technology. A rebuttal. Hum reprod Gleicher N. Safety issues in assisted reproduction technology. A rebuttal. Hum reprod 2003; 18(9):1765-1766.2003; 18(9):1765-1766.
Safety issues in assisted reproduction technology
ConclusionConclusion2. 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.
Safety issues in assisted reproduction technology
ConclusionConclusion3. Protection of the vulnerable is
the physician’s responsibility.
Safety issues in assisted reproduction technology
ConclusionConclusion4. The advisability of offering a The advisability of offering a
therapy should always be therapy should always be evaluated in light of the best evaluated in light of the best interest of the future offspring.interest of the future offspring.