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W2102567187 abstract "After completing this article, readers should be able to: In the 1977 ruling “Carey v. Population Services International,” the United States Supreme Court ruled that the decision to bear children is constitutionally protected. (1) Significant interest already had been shown in the development and improvements of in vitro fertilization (IVF) for infertile couples. The first human pregnancy and human birth using IVF were reported by Steptoe and Edwards in the United Kingdom. (2) Their work resulted in the first baby born via reproductive technologies, Louise Brown, born on July 25, 1978, at Oldham General Hospital in Oldham, United Kingdom. (3) She was born via a planned cesarean section, and her birthweight was 2.61 kg. The first successful viable IVF in the United States was performed by Jones and Seager-Jones in 1981 in Norfolk, Virginia. (4)Assisted reproductive technologies (ART) have seen a recent surge in popularity. The Centers for Disease Control and Prevention (CDC) reported that 122,872 cycles of ART were initiated in 2003, resulting in the delivery of 48,756 neonates, (5) accounting for approximately 1% of all neonates delivered in the United States. The percentage is higher in many countries, including Denmark, where it is estimated that 5% of all deliveries are with the assistance of ART. (6) Couples pursue ART for myriad reasons, including tubal transport factors, ovulatory dysfunction, uterine factors, endometriosis, male- and female-specific factors, and when a cause of infertility is unknown. (5)It would be very difficult to design randomized controlled trials, blinded or not, to study the effects of ART compared with natural conception. Much of the information relies on observational studies, always prone to observational bias, or small cohort studies that may not have significant power. However, available data suggest that ART pregnancies are associated with increased parental stress (7) and involve more frequent interventions, including earlier elective cesarean sections. (8,9). The sensitivity of the clinician to intervene (treatment bias) likely also affects outcomes. Bias is difficult to remove from most of the known trials comparing ART and natural conception.Initial studies of singleton infants born with the assistance of ART showed a significantly increased rate of low birthweight and prematurity. One of the first large-scale studies was an examination of the French national registry from 1986 through 1990, which showed a prematurity rate for ART births of 29.3% and a low birthweight (LBW) rate of 36.2%, much higher than national averages. (10) Multiple studies in the last 10 years have continued to show that singleton pregnancies from ART are more likely to be preterm, result in LBW infants, and have complications associated with prematurity and LBW, including perinatal mortality. A summary of recent journal articles comparing ART singletons and naturally conceived singletons is shown in Table 1.Unlike singleton pregnancies, twin births with ART appear not to have dramatically increased risk profiles compared with naturally conceived twin controls. It is generally known that there is an increased incidence of having multiple births with ART compared with naturally conceived births. In fact, 2003 CDC data showed only 35,785 deliveries for 48,756 ART infants born, indicating that 26.6% of ART infants born are part of a multiple birth. (5) To increase the likelihood of successful implantation, most ART procedures implant multiple embryos, likely raising rates of multiple births.Results of numerous studies comparing twins conceived through ART with twins conceived naturally are displayed in Table 2. Most of the studies show no increased risk of LBW or prematurity for ART twins. Unlike much of the literature, two articles, one original (19) and one systematic review (18), reported a small, albeit significant, increased risk of being born between 32 and 36 weeks’ gestation. The small number of infants reported in the original article makes its results difficult to generalize.Nonetheless, risks remain markedly lower for twins than for ART singletons compared with naturally conceived controls. It is currently unclear why ART twins do not have as high of an increased risk as ART singletons. One explanation may be the higher proportion of monozygotic twins in naturally conceived twin births as opposed to ART births. A 2005 study reported that 95% of twins conceived with ART were dizygotic, and only 5% were monozygotic, (20) which differs markedly from the general population, in which the numbers trend closer to 50:50. Among naturally conceived twin gestations, monozygotic twins tend to have an increased risk of prematurity and LBW. A study of 3,458 twin live births in the state of Washington between 1984 and 1988 found an increased risk for LBW and shorter gestations among monozygotic twins. (21) With the increased likelihood in natural conception of having monozygotic twins, the likelihood of associated adverse perinatal outcomes is increased. This effect may partially balance out any increased risk of ART twin births compared with naturally conceived twin births.According to the CDC, 3.2% of ART pregnancies in 2003 that ended in live births resulted in triplets or even higher order gestation. As of 1996, that number had been as high as 7%. (5) Many reproductive endocrinologists have noted the relationship between multiple gestations and poor outcomes for ART. In fact, among all gestations, twins are three times more likely than singletons to develop cerebral palsy, and triplets are 10 times more likely to develop cerebral palsy. (22) The study of the French National Registry found that ART triplet gestations are at a higher risk of prematurity prior to 32 weeks’ gestation (23.6%) than ART singletons (1.2%) or ART twins (5.1%). (10) ART triplets also have an increased risk of LBW (95%) compared with ART singletons (11%) and ART twins (57%).Of note, the chorionicity of ART triplet gestations has been shown to be important for perinatal outcomes. A study from early 2006 noted that dichorionic-triamniotic gestations have an increased risk of perinatal mortality compared with trichorionic-triamniotic gestations, with an odds ratio of 7.9 (4.4 to 14.0). (23) Dichorionic-triamniotic gestations also had an increased risk of very low-birthweight (VLBW) and preterm birth before 30 weeks’ gestation.Due to this and other risks, many centers have now ceased using triple-embryo transfers in their ART procedures in favor of single- or two-embryo transfers. Triplet gestations are becoming less frequent due to the procedures being performed.One of the most difficult areas to investigate is the role of infertility in causing increased risks of adverse outcomes seen in ART births compared with naturally conceived births. A study was performed in women in Leicestershire, United Kingdom, who had pregnancies after having a documented period of infertility, with or without treatment. (24) The authors reported that women with untreated infertility who then had pregnancies were at increased risk of perinatal death compared with women without infertility, with a relative risk of 3.3 (1.6 to 6.8). A history of infertility prior to the described pregnancy, regardless of treatment, was associated with an increased risk of perinatal death, with an odds ratio of 2.9 (1.8 to 4.5). A history of treated infertility also showed an increased risk of perinatal death compared with controls, with a relative risk of 2.7 (1.5 to 4.7). A 1997 report studied two groups of women, one of whom were concerned with subfertility and who likely had a history of difficulty conceiving, and the other of whom had undergone therapeutic interventions for infertility such as ovarian stimulation, IVF, or artificial insemination. (25) The group concerned with subfertility and who subsequently had spontaneous pregnancies had an increased risk of having an infant who was VLBW, with a relative risk of 1.4 (1.1 to 1.9). This suggests that a history of infertility might be a source of increased perinatal risk. The group who had undergone intervention had an increased risk of having an infant who was VLBW, with a relative risk of 2.6 (2.1 to 3.2).More research is needed regarding the role of infertility in adverse outcomes of ART. One possible future study area is specific causes of infertility and determining specific risks depending on the cause of infertility.With an increased rate of prematurity and LBW in ART infants, particularly singletons, an increased rate of intraventricular hemorrhage would be expected compared with naturally conceived infants. A 2003 study reported that fertility treatment is an independent risk factor for high-grade intraventricular hemorrhage, even after correction in a multivariate regression model for birthweight, multiple gestations, and gestational age. (26) The odds ratio was 4.34 (1.42 to 13.3) for ART infants compared with control infants. In a study of 73 ART twin deliveries and 148 naturally conceived twin deliveries, the authors found a rate of intraventricular hemorrhage of 15.4% for the ART twins versus 3.9% for the naturally conceived twins, a statistically significant difference (P<0.01). (19) However, a study involving cranial ultrasonography in 1,473 VLBW infants failed to find any evidence of increased risk of intraventricular hemorrhage in association with ART. (27)The role of ART in the incidence of birth defects is still controversial. Unfortunately, many studies have shown widely varied results, likely due, in part, to the center of study as well as the population studied. Results and statistics from many of the large birth defect studies are displayed in Table 3.Initial data did not show any increased risk of congenital malformations in infants born via ART. A study from the French National Registry of 6,879 newborns published in 1995 showed a rate of congenital malformations of 2.8% in the ART group and 2.1% in the control group. (10) A 1996 study reported a congenital malformation rate of 3.3% for a group of 423 children conceived via intracytoplasmic sperm injection (ICSI), which was within expected ranges for the general population. (33) The same group reported in 1999 on an analysis of 1,987 children conceived via ICSI that had a 2.3% rate of major congenital malformations, also within expected population limits. (34) A 2002 study reported no significant difference between malformation rates of standard IVF (3.8%) and ICSI (3.4%). (28)Some authors have reported small increases in specific birth defect rates in infants born via ART. For example, a 2001 Swedish population study reported an increase in rates of neural tube defects and omphaloceles for ART infants compared with Swedish general population controls. (35) The authors also reported a higher incidence of hypospadias with infants conceived via ICSI. Of note, two large birth defect studies that did report higher incidences of overall birth defects did not find any increased rate of male genital malformations. (31)(32) A 2002 article described an odds ratio of 4.0 (1.4 to 11.7) for congenital heart malformations in ART infants compared with controls. (36) A group in 1999 studied the outcomes of 5,800 ART infants and more than 1.5 million naturally conceived infants, finding that the ART infants had a particularly increased incidence of neural tube defects and esophageal atresia. (29) A 2005 meta-analysis concluded that ICSI itself was not associated with a higher incidence of total number of birth defects than standard IVF, nor was there any specific organ system that showed a higher rate of birth defects. (37)Some more recent studies have begun to show a small but increased overall risk of congenital malformations among ART infants compared with naturally conceived infants. A 1999 study reported an increased odds ratio of 1.39 (1.25 to 1.54) of having a major congenital malformation. (29) In 2000, a group compared 1,139 ICSI infants with Swedish population statistics, finding an odds ratio of 1.75 (1.19 to 2.58) of having a major or minor birth defect for ART births. (30) When stratified for multiple gestations, however, the odds ratio became 1.19 (0.79 to 1.81), implying that the increased rate of congenital anomalies in ART births was due to the increased rate of multiple-gestation births. A large study in 2004 compared 3,372 ICSI children and 8,016 naturally conceived children and found an 8.7% rate of congenital malformations for the ICSI births compared with 6.1% in the general population. (14) The odds ratio of developing a birth defect after controlling for maternal age and multiple gestations was 1.24 (1.02 to 1.50). A large study from Western Australia examined 301 IVF infants, 837 ICSI infants, and 4,000 naturally conceived controls. (31) The authors found an unadjusted odds ratio of developing congenital birth defects of 2.2 (1.3 to 3.3) for ICSI and 2.6 (1.7 to 3.0) for IVF compared with controls. On adjustment for multiple gestations and maternal age and parity, the odds ratios remained significantly elevated at 2.0 (1.3 to 3.2) and 2.0 (1.5 to 2.9) for ICSI and IVF, respectively. A group at the University of Iowa in 2005 compared 1,462 ART children with 8,411 naturally conceived children. (32) They found that 6.2% of ART children and 4.4% of naturally conceived children had major birth defects, indicating an adjusted odds ratio of 1.30 (1.00 to 1.67) of developing major birth defects after ART.Many of these studies used different criteria for birth defects and reported findings on children at different ages, which makes it difficult to draw a definitive conclusion as to whether ART itself contributes to a higher rate of birth defects. It is likely that there is at least a small but significant increase in the risk of birth defects in children born via ART compared with naturally conceived controls.A report from 2005 described seven children who presented with early breast development or early pubic hair development, and all seven had been conceived with ART. (38) Because of the use of exogenous hormones by reproductive endocrinologists in ART, this certainly heightened anxiety about a new potential adverse outcome. The children, ages 5 to 21 months, were seen by pediatric endocrinologists at the New York University School of Medicine in 2004. Their evaluations failed to reveal abnormal sex hormone concentrations or abnormal gonadal or uterine structure. At the time of the report in 2005, none of the children had further progression in their thelarche or pubarche.A 1996 study from Australia examined 314 IVF children and 150 control children for appropriate growth at the age of 2 years. (39) There was no difference in mean weight or mean head circumference between the two groups. The authors did note a poorer overall growth for twins compared with singleton births in both groups.Prenatal diagnosis typically is offered for parents who have significant risk factors for chromosome abnormalities. Because the majority of studies have not shown an increased incidence of chromosomal abnormalities in ART births compared with naturally conceived controls, prenatal genetic testing has not been recommended for ART pregnancies. A 2002 study, however, reported an increase in chromosomal abnormalities in ICSI prenatal karyotypes compared with naturally conceived controls. (28) The authors found a rate of de novo chromosomal abnormalities of 1.6% for the ICSI births and 0.5% in the control group. They noted that the ICSI births had a larger number of sex chromosome abnormalities. They also found a rate of inherited anomalies of 1.4% in the ICSI births compared with 0.3% to 0.4% of prenatal tests in the general population. Most of the inherited anomalies were due to paternally inherited chromosomal anomalies.These findings raise the concern for cases where paternal genetic factors are the cause of infertility. Because many male infants born after ART have been shown to carry their father’s Y-chromosome microdeletions, (40) the ICSI procedure itself may be contributing to the increased chromosomal abnormalities seen in the study. It is unknown if male children born via ICSI eventually will have an increased rate of infertility.There is no evidence at this time to suggest an increase in the rate of chromosomal abnormalities with standard IVF.Genomic imprinting occurs when gene expression is dependent on the parental origin of that gene. Only about 50 genes in the entire genome have been implicated in imprinting, and most of them control pre- or postnatal growth. (41) The kinship theory suggests the existence of opposing evolutionary forces between maternal investment in an individual offspring and the mother’s future reproductive capabilities. Maternal investment is anything that increases the chances of an offspring’s future reproductive success at the cost of the mother’s ability to invest in later offspring. The theory states that paternal-specific gene expression promotes an increase in maternal investment, and maternal-specific gene expression is imprinted to reduce the maternal investment in favor of future reproductive capabilities. For example, paternal genes are imprinted to increase fetal growth, as this increases the likelihood of offspring reaching reproductive maturity. Maternal genes are imprinted to limit fetal growth because excess intrauterine growth could risk loss of the mother’s reproductive capability.Epigenetic alterations are physical changes in DNA that alter its expression without changes in its primary sequence. Like alteration in the primary DNA sequence, epigenetic changes are believed to be inheritable. DNA methylation is an epigenetic change that consists of methyl groups being attached to cytosine/guanine pairs (CpGs). CpGs can occur in clusters, creating methylated or unmethylated “islands” that can regulate regional transcription by blocking methylation-sensitive transcription proteins. (42) Generally, areas of increased methylation are more resistant to transcription and, therefore, have lower levels of gene expression. Offspring inherit different methylation patterns from each parent, resulting in different gene expression, depending on the parental origin of the gene. Thus, DNA methylation has an integral role in imprinted genes. Recently, there have been observations suggesting a link between ART, diseases caused by imprinting errors, and epigenetic alterations.Beckwith-Wiedemann Syndrome (BWS) is characterized by macrosomia, macroglossia, midline abdominal wall defects, and an increased risk for embryonal cancers. (43) BWS is due to alterations in the expression of chromosome 11p15 due to deletion, uniparental disomy (UPD), or epigenetic alterations. Chromosome 11p15 contains the gene for insulin-like growth factor 2 (IGF2), H19, (44) and LIT1. Some 45% to 65% of patients who have BWS have defects in maternal imprinting of one of these three genes. (45) The loss of maternal imprinting leading to loss of the maternal fetal growth suppression is a dramatic illustration of the kinship theory.Several studies have observed an increased incidence of BWS in children who are products of ART. A retrospective chart review from the United Kingdom of 149 patients who had BWS examined the incidence of the syndrome in ART infants compared with the general population. (46). The authors predicted 1.73 ART-born infants out of the 149 patient who had BWS but found a total of 6 (RR=4, P=0.009). UPD studies were preformed in four of the six individuals, and all results were negative. Two were assessed for methylation abnormalities, and both showed loss of methylation of the maternal allele. The national report of the French Registry (45) showed that 4% of the patients who had BWS were born via ART, which is significantly greater than that of the general population (1.3%, RR=3.2, P=0.01). All six of these patients showed the same epigenetic abnormality of isolated hypomethylation. Another study identified seven individuals who had BWS conceived by ART, with six having imprinting defects in LIT1 and one having imprinting defects in both LIT1 and H19/IGF2 (RR=6). (46) Although these are mostly small, retrospective studies, their combined results are highly suggestive of an association between ART and imprinting defects resulting in BWS.Angelman Syndrome (AS) is a disorder characterized by severe mental retardation, absence of speech, poor motor development, and a “happy” disposition. (47) Most cases of AS are due to a maternal deletion in chromosome 15q11–13, although 4% of AS cases are due to microdeletion or epigenetic changes of an imprinting control center (ICC). The association between ICSI and AS was reported initially in 2002 with two cases of AS in children conceived by ICSI. (47) Molecular analysis for UPD and ICC mutations were negative in both children, but both had hypomethylation of 15p11, indicating a sporadic imprinting defect on the maternal chromosome. A case report has been published of another individual who had AS born via ICSI who showed a complete lack of methylation of the maternal gene. (48) The rate of AS in the general population is approximately 1 in 15,000, with, at most, 5% of these being the result of spontaneous imprinting defects (1 in 300,000). (47) Therefore, three individual case of AS with imprinting defects would be expect to occur in 900,000 ICSI births. The current estimation of total ICSI births since 1978 is approximately 1,000,000. Because it is extremely unlikely that every case of AS that is a product of ICSI has been reported, it can be inferred that ICSI likely increases the risk of hypomethylation of the maternal 15p11–13 chromosome and subsequent AS.Retinoblastoma (RB) is an embryonal tumor of the retina associated with mutations of the RB1 gene on chromosome 13q14. (49) CpG methylation in the RB promoter inhibits binding of the retinoblastoma binding factor 1 and the activating transcription factor-like factors, resulting in a reduction of RB promoter and tumor suppressor activity. (50) The incidence of RB in the IVF population in the Netherlands (1 in 17,000) would be 0.69 cases between 1995 and 2001 (51) if the rate was same as that of the general population. However, five cases of RB in IVF individuals have been reported during that time. Unfortunately, the authors did not present the results of methylation studies or RB1 expression.Data from animal husbandry has demonstrated that ART may produce an entity known as “large offspring syndrome” (LOS). Studies in sheep and cattle show that ART offspring are 8% to 50% larger than nonART offspring, with an incidence approaching 100%. (52) Several studies have shown that the LOS phenotype is associated with methylation changes in IGF2R and H19, which has been linked to the composition of the medium used for embryonic cell culture. (52)(53) It also has been hypothesized that the critical difference in culture medium may be the methionine content, which has been shown to alter DNA methylation. (49) Most producers of human embryo culture media do not divulge the formulations of the media to IVF clinics, and these products are poorly regulated by the United States Food and Drug Administration. (49)It has not yet been determined if the imprinting of other growth-regulating genes supports the kinship theory or if it is just a select few, such as LIT1, IGF2, and H19. It has been shown, however, that alterations in epigenetic control of imprinted genes can have profound clinical consequences by disrupting the delicate balance between maternal and paternal control of gene expression. Due to the rare occurrence of many of these genetic changes, it has been suggested that they will not have significant impact on ART outcomes. Others believe that BWS, AS, and RB are the extremes of a much more subtle process that demands further investigation. Because epigenetic changes are inheritable, these problems may not be immediately apparent, but will be seen in subsequent generations. Further studies may shed light on methods to minimize imprinting abnormalities and optimize ART outcomes.An unfortunate outcome more common in preterm and VLBW infants is cerebral palsy and mental retardation. ART has been shown to be a significant risk factor for prematurity and LBW when compared with naturally conceived controls. ARTs themselves do not appear to have an independent role in the causation of these neurologic sequelae.In 2002, a case-control study was published in which 5,680 ART infants and 11,360 naturally conceived infants were followed until the age of 14 years. (54) Based on raw data, infants born following ART were 3.7 times more likely (2.0 to 6.6) of developing cerebral palsy compared with naturally conceived controls. However, when adjusted for LBW, prematurity, and multiple gestations, ART was not shown to be an independent risk factor for cerebral palsy. A 2004 study compared 5,130 ART singletons and 3,393 ART twins with 10,239 naturally conceived children, following them until they were all at least 2 years of age. (55) The authors did not find a statistically significant difference between study groups for neurologic sequelae. The significant independent risk factors for neurologic sequelae included male sex, delivery before 37 weeks’ gestation, and LBW. There is some evidence that monochorionicity is associated with a higher risk of adverse neurologic sequelae. (56) Because this is more common in naturally conceived pregnancies, it may balance out any small independent effect that ART contributes.An initial study in 1998 described an increased risk of a lower score on the Bayley Scales of Infant Development in children born following ICSI (95.9 [64 to 123]) compared with IVF (101.8 [82 to 122]) or naturally conceived controls (102.5 [82 to 118]). (57) This was significant, with a P value less than 0.0001. However, research since that time has not duplicated this result. A follow-up study in 2003 concluded that by the age of 5 years, the ICSI children did not have significantly different cognitive abilities compared with the IVF or naturally conceived controls. (58) In another observational study of 208 ART singletons and 211 matched naturally conceived singletons in the United Kingdom, the authors found no significant difference between the two groups in their neurodevelopmental scores on screening after the age of 12 months. (59) The same group studied 58 ART singletons and 38 naturally conceived controls in Australia and failed to find any difference in their neurodevelopmental scores. (60) Additionally, they found no overall difference in the cohorts from the United Kingdom compared with the Australian cohorts. There was also no significant difference in the Bayley Scales of Infant Development scores between groups of Greek 12-month-old infants who had been born following ICSI, IVF, or natural conception. (61)In 2005, a large multinational study was reported in which the Wechsler Preschool and Primary Scale of Intelligence – Revised (WPPSI-R) was used to assess 5-year-old children for cognitive function. (62) The study included 511 ICSI children, 424 IVF children, and 488 naturally conceived controls. No significant difference was seen between any of the three groups in either the verbal or performance scores of the WPPSI-R. The McCarthy Scales of Children’s Abilities was used to assess motor skills in the same groups of children, and no significant difference was found. There was also no significant difference in motor development between groups of Greek 12-month-old infants born following ICSI, IVF, or natural conception. (61)A survey of a large multinational cohort of ART families and control families in Europe revealed that mothers of children born via ART actually reported less parenting stress and more positive parent-child relationships. (63) The investigators also did not find any difference in self-esteem or behavioral or emotional problems with the children. In 1999, a report was published of 743 IVF children older than the age of 4 years who were surveyed via Achenbach psychological questionnaires, focusing on problem areas such as aggression, social problems, thought problems, attention problems, and delinquency. (64) The authors did not find any difference between the IVF children and the Achenbach normative values. A group in 2001 performed a longitudinal study of a cohort of ART children who had begun to enter adolescence. (65) They interviewed and sent questionnaires to families with children born via ART and control families with children born via natural conception. The authors did not find any significant difference in parent-child relationships or in child psychological and emotional adjustment. A second cohort followed by the same authors in 2002 also did not show any difference in relationships or adjustment, and the authors noted a positive effect of a history of ART on parent-child function measures. (66) A 2002 study surveyed both parents as well as teachers of matched cohorts of ART children and naturally conceived children, finding no significant differences between parental surveys for parental stress or behavior problems. (67) Teacher surveys also did not show a significant difference between the two groups.Evidence in the current literature supports an increased incidence of prematurity and LBW in ART singleton births compared with naturally conceived singleton births. Singleton ART births likewise have a higher incidence of all complications associated with prematurity and LBW compared with naturally conceived singletons. ART twin births may have a slightly elevated risk of prematurity and LBW than naturally conceived twin births, but the difference is likely minimal. The effect of ART on twin gestations probably is balanced by the higher proportion of monozygotic twins in naturally conceived births.Additionally, there has been a suggestion that ART births have a small but significantly increased incidence of birth defects, but this is difficult to state definitively. Association of ART with specific defects remains speculative, but certainly warrants further research, particularly with the effect of ICSI on male genital development.ART births have been shown to have an increased likelihood of having neurologic sequelae such as cerebral palsy and mental retardation when compared with naturally conceived controls. When adjusted for gestational age, LBW, and rate of multiple gestations, ART has not been shown to be an independent factor for adverse neurologic outcomes. As techniques and technology improve in ART, it is expected that the rates of adverse neurologic outcomes also will improve. ART births are not associated with worsened cognitive, motor, emotional, or behavioral developmentART births are associated with an increased incidence of imprinting defects, resulting in a higher incidence of BWS and AS. It remains unclear but possible that there is a link between ART and incidence of RB. Epigenetics remains a significant field of study in the role of ART and genetic complications. More genetic research is needed to elucidate any true effect seen in these children. Evidence reveals that the diagnosis of infertility itself may increase the risk of perinatal complications." @default.
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W2102567187 title "Developmental and Genetic Outcomes in Children Conceived Through Assisted Reproductive Technologies" @default.
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