Treatment for infertility using assisted reproductive technologies (ART) is highly successful and has been used to help a steadily growing number of couples worldwide. In 1999, in the United States, more than 86,000 treatment cycles were performed resulting in the birth of more than 30,000 babies. Despite this widespread application, few follow-up studies of children conceived through ART have been performed, and more rigorous investigation of this important issue has clearly been needed. In recent months, three studies linking ART with several complications have been published in high profile and widely read general medical journals: Schieve et al. (1) reported that singletons conceived using ART were at an increased risk for low birth weight, whereas Hansen et al. (2) suggested an increased risk of major birth defects. Finally, Stromberg et al. (3) concluded that children conceived through IVF have an increased risk of neurological problems, especially cerebral palsy. The importance of these studies is obvious as they provide clues of possible risks associated with ART. However, they are all retrospective analyses of data collected through registries and therefore are vulnerable to biases inherent to such study design. We must be careful not to overinterpret the data by concluding that the use of ART, whether from gamete or embryo manipulation or use of medications, is the direct cause of the complications—the observed associations may simply be explained by one or more confounders, such as an underlying infertility-related condition in the treated women. This short communication is an attempt to place these three articles in proper perspective for the clinician and to provide the impetus for conducting further studies to determine the true nature of the described associations. At the outset, it should be stated that a major weakness of all three studies is the lack of proper controls. If the aim of a study is to determine whether a cause and effect relationship exists between the process of IVF and a specific outcome (i.e., low birth weight, major birth defects, neurological problems), the appropriate control population is that of babies born to infertile women achieving pregnancies by methods other than IVF. None of the three studies specifically included such a control population.
Abstract Do children conceived by assisted reproductive technology (ART) have increased overall or cause-specific mortality risk through adolescence, compared with children not conceived by ART? Reassuringly, after median follow-up of 17 years, overall and cause-specific mortality risk was not increased in ART-conceived children compared with non-ART-conceived children. More than 10 million children worldwide have been born as a result of ART. While there is evidence of increased risk of perinatal mortality and perinatal complications among babies born after ART, little is known about overall and cause-specific mortality risk in children and adolescents. Since the proportion of children born after ART has increased dramatically in recent decades, it is important from a public health perspective to investigate overall and cause-specific mortality in ART-offspring, particularly up to adolescence and young adulthood. Study design, size, duration
Data were used from the OMEGA cohort, a historical nationwide cohort with prospective follow-up in The Netherlands. Children of women who were treated in one of the 13 IVF clinics or 2 regional fertility centers during 1983-2011 were included. Of 83,413 live-born children, 47,870 were ART-conceived and 35,543 were not ART-conceived (conceived naturally with or without ovarian stimulation among subfertile couples). Participants/materials, setting, Data on type of fertility treatment and maternal risk factors were available from maternal medical records and the Dutch Perinatal Registry. Complete information on date and cause of death was ascertained through Statistics Netherlands through 2019. The mortality risk in ART children was compared with the mortality risk in non-ART children, using Cox regression analysis (adjusted hazard ratios [HRs]) and with mortality risk in children from the general Dutch population, calculating standardized mortality ratios (SMRs). Main Median age at end of follow-up was 17.5 years (IQR=12.1-24.3) and was shorter in ART-conceived children (16.0 years) than in non-ART children (19.8 years). In total, 718 children died, 399 in the ART group and 319 in the non-ART group, median age of death was 0.02 (IQR=0.00-0.40) and 0.14 years (IQR=0.00-15.93), respectively. Overall mortality risk was not increased in ART-conceived children compared with children of subfertile couples not conceived by ART (HR = 1.02, 95%CI=0.87-1.20), also not for IVF and ICSI specifically (HR = 1.08, 95%CI=0.91-1.28; HR = 0.90, 95%CI=0.71-1.12, respectively). However, for IVF-conceived children, mortality risk was increased in the first 6 months of life (<6 months: HR = 1.23, 95%CI=1.00-1.51) compared with children not conceived by ART. IVF-conceived children were at increased risk of death due to perinatal complications compared with non-ART children (HR = 1.29, 95%CI=1.02-1.65). For ICSI-conceived children, no increased risks were observed. Risks of overall mortality in children aged ≥6 months were non-significantly decreased (>6 months: HR = 0.81, 95%CI=0.61-1.08; HR = 0.81, 95%CI=0.59-1.10; HR = 0.83, 95%CI=0.50-1.36). Overall mortality risk among ART-children was increased compared with mortality incidence in the general population (SMR=1.19, 95%CI=1.08-1.32), mainly driven by excess deaths due to conditions originating in the perinatal period (SMR=2.01, 95%CI=1.76-2.30). No other increased cause-specific mortality risks were observed. Limitations, Despite the large cohort and long-term follow-up, the absolute number of deaths was small, which limited the power to detect differences in some subgroups. In addition, results are largely based on ART treatment protocols used until 2011, consequently, it is uncertain how study results generalize to more contemporary ART treatment. These results contribute to knowledge about long-term health risks in ART-offspring. Reassuringly, long-term mortality up to the age of 24 years among ART-conceived children was similar to mortality in non-ART children and the general population. This knowledge is important for ART children, future parents considering ART, and physicians. No
Sharma M et al., 2024·J Perinatol·Free full text on PubMed Central
To determine the association between fertility treatment, socioeconomic status (SES), and neonatal and post-neonatal mortality. Retrospective cohort study of all births (19,350,344) and infant deaths from 2014-2018 in the United States. The exposure was mode of conception-spontaneous vs fertility treatment. The outcome was neonatal (<28d), and post-neonatal (28d-1y) mortality. Multivariable logistic models were stratified by SES. The fertility treatment group had statistically significantly higher odds of neonatal mortality (high SES OR 1.59; CI [1.5, 1.68], low SES OR 2.11; CI [1.79, 2.48]) and lower odds of post-neonatal mortality (high SES OR 0.87, CI [0.76, 0.996], low SES OR 0.6, CI [0.38, 0.95]). SES significantly modified the effect of ART/NIFT on neonatal and post-neonatal mortality. Fertility treatment is associated with higher neonatal and lower post-neonatal mortality and SES modifies this effect. Socioeconomic policies and support for vulnerable families may help reduce rates of infant mortality.
Freezing and Storage · Embryo Freezing and Storage
Sciorio R et al., 2023·Journal of clinical medicine·Free full text on PubMed Central
Since the birth of Louise Brown in 1978, more than nine million children have been conceived using assisted reproductive technologies (ARTs). While the great majority of children are healthy, there are concerns about the potential epigenetic consequences of gametes and embryo manipulation. In fact, during the preimplantation period, major waves of epigenetic reprogramming occur. Epigenetic reprogramming is susceptible to environmental changes induced by ovarian stimulation, in-vitro fertilization, and embryo culture, as well as cryopreservation procedures. This review summarizes the evidence relating to oocytes and embryo cryopreservation and potential epigenetic regulation. Overall, it appears that the stress induced by vitrification, including osmotic shock, temperature and pH changes, and toxicity of cryoprotectants, might induce epigenetic and transcriptomic changes in oocytes and embryos. It is currently unclear if these changes will have potential consequences for the health of future offspring.
Hariton E et al., 2023·Fertility and Sterility·Free to read
The field of reproductive endocrinology and infertility (REI) is at a crossroads; there is a mismatch between demand for reproductive endocrinology, infertility and assisted reproductive technology (ART) services, and availability of care. This document's focus is to provide data justifying the critical need for increased provision of fertility services in the United States now and into the future, offer approaches to rectify the developing physician shortage problem, and suggest a framework for the discussion on how to meet that increase in demand. The Society of REI recommend the following: 1. Our field should aggressively explore and implement courses of action to increase the number of qualified, highly trained REI physicians trained annually. We recommend efforts to increase the number of REI fellowships and the size complement of existing fellowships be prioritized where possible. These courses of action include: a. Increase the number of REI fellowship training programs. b. Increase the number of fellows trained at current REI fellowship programs. c. The pros and cons of a 2-year focused clinical fellowship track for fellows interested primarily in ART practice were extensively explored. We do not recommend shortening the REI fellowship to 2 years at this time, because efforts should be focused on increasing the number of fellowship training slots (1a and b). 2. It is recommended that the field aggressively implements courses of action to increase the number of and appropriate usage of non-REI providers to increase clinical efficiency under appropriate board-certified REI physician supervision. 3. Automating processes through technologic improvements can free providers at all levels to practice at the top of their license.
Goldsmith S et al., 2018·Developmental medicine and child neurology
To calculate the birth prevalence of cerebral palsy (CP) after assisted reproductive technology (ART) and compare the clinical outcomes of children with CP after ART or natural conception. This cohort study used linked CP and ART register data from live births in Western Australia (1994-2002). Birth prevalence was calculated and data analysed using descriptive statistics and logistic regression. It was adjusted for confounding variables and stratified by plurality and gestational age. In total, 211 660 live births were included; prevalence of CP was increased in children born after ART (7.2/1000 live births compared with naturally conceived births, 2.5/1000). Odds of CP were doubled for singletons; when stratified by gestational age odds were only increased in the under 32-week group. Prevalence of CP was increased in ART (9.9/1000 live births) and naturally conceived twins (8.4/1000 live births). Clinical outcomes were similar between ART and naturally conceived children. The birth prevalence of CP is increased two-fold after ART. After stratification for gestational age and plurality, residual risk remains in singletons born very preterm. Birth prevalence of CP will be tracked over time to identify any impact of changes to clinical practice. In Western Australia, assisted reproductive technology (ART) increases birth prevalence of cerebral palsy (CP), mediated mostly by preterm and multiple births. Preterm birth alone does not account for the doubled odds of CP for ART singletons born very preterm. Clinical outcomes are similar between ART and naturally conceived children with CP.
Barnhart KT, 2013·Fertility and Sterility·Free full text on PubMed Central
Interrogating the association between assisted reproductive technologies (ART) and perinatal outcome is complicated but very important. This is an introduction to a series of articles that review this potential association with an eye toward etiology of risk, and what aspects of in vitro fertilization (IVF) can be modified to reduce this risk. When an association is not due to chance (i.e., statistically significant), one must also consider how the association may be affected due to bias or confounding. Despite lack of the perfect study, perinatal consequences of ART are apparent, even though the vast majority of children conceived with ART are healthy. Pregnancy after IVF is altered as evidenced by risk of preterm delivery, low birth weight among infants, and an alerted prevalence of preeclampsia. The long-term clinical implications of ART, such as childhood development and metabolism, have not been established and ongoing study is proceeding. The risk attributed to multiple births is iatrogenic and needs to be minimized. Optimizing the environment at the time a woman conceives will likely have an effect on gestation as well as the health of children. Reproduction effects health and health effects reproduction.
Hansen M et al., 2014·Seminars in Fetal and Neonatal Medicine·Free to read
Pooled odds ratios from meta-analyses of infants born following assisted reproductive technologies (ART) compared with non-ART singletons show increases in low birth weight, preterm birth, small for gestational age, and birth defects. Although there have been small reductions in recent data, odds associated with these outcomes are still higher for ART singletons. Both ART procedures and underlying infertility contribute to these increased risks. Outcomes appear better for frozen-thawed compared with fresh embryo transfers, but are poorer than for non-ART infants. There is a concerning increase in large-for-gestational-age infants born following frozen-thawed embryo transfer and limited data on the effects of embryo vitrification used instead of slow-freezing techniques. Using large datasets, we now need to investigate risks of individual birth defects and disentangle the inter-related effects of different types of infertility and the multiple aspects of ART. Greater understanding of the causes of adverse ART outcomes and identification of modifiable risk factors may lead to further reductions in the disparities in outcome between ART and non-ART infants.
There is an absence of population-based long-term studies on the risk of neurological sequelae in children born after in-vitro fertilisation (IVF). Our aim was to compare the frequency of such problems between IVF-born children and controls. We did a population-based retrospective cohort study in which we compared development of neurological problems in 5680 children born after IVF, with 11360 matched controls. For 2060 twins born after IVF, a second set of controls (n=4120), all twins, were selected. We obtained data on neurological problems from the records of the Swedish habilitation centres. Children born after IVF are more likely to need habilitation services than controls (odds ratio 1.7, 95% CI 1.3-2.2). For singletons, the risk was 1.4 (1.0-2.1). The most common neurological diagnosis was cerebral palsy, for which children born after IVF had an increased risk of 3.7(2.0-6.6), and IVF singletons of 2.8 (1.3-5.8). Suspected developmental delay was increased four-fold (1.9-8.3) in children born after IVF. Twins born after IVF did not differ from control twins with respect to risk of neurological sequelae. Low-birthweight and premature infants were more likely to need habilitation than fullterm babies. Maternal age did not affect risk. Our study suggests that children born after IVF have an increased risk of developing neurological problems, especially cerebral palsy. These risks are largely due to the high frequency of twin pregnancies, low birthweight, and prematurity among babies born after IVF. To limit these risks, we recommend that only one embryo should be transferred during IVF.
Assisted Reproduction › Safety and Risks › Procedure-Attributable Risk · Research Methods › Study Design › Real-World Evidence and Claims Data
Paolo Rinaudo, Christos Coutifaris, George Kovalevsky
P Rinaudo, C Coutifaris, G Kovalevsky
PMID 12798870 12798870 DOI 10.1016/s0015-0282(03)00397-2 10.1016/s0015-0282(03)00397-2 Kovalevsky et al. 2003, Kovalevsky 2003
Cite this article
Kovalevsky, G., Rinaudo, P., & Coutifaris, C. (2003). Do assisted reproductive technologies cause adverse fetal outcomes? Fertility and Sterility, 79(6), 1270-1272. https://doi.org/10.1016/s0015-0282(03)00397-2
Kovalevsky G, Rinaudo P, Coutifaris C. Do assisted reproductive technologies cause adverse fetal outcomes? Fertil Steril. 2003;79(6):1270-1272. doi:10.1016/s0015-0282(03)00397-2
Kovalevsky, G., et al. "Do assisted reproductive technologies cause adverse fetal outcomes?" Fertility and Sterility, vol. 79, no. 6, 2003, pp. 1270-1272.