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• W3134765870 abstract "There is an ongoing debate about whether assisted reproductive technology (ART) procedures themselves are responsible for undesirable pregnancy outcomes or if these outcomes are related to the underlying patient diagnoses that necessitate ART in the first place. The study by Libby et al. (1Libby V. DeVilbiss E. Chung M. Dilday E. Babayev S.N. Weinerman R. et al.Obstetric outcomes in pregnancies resulting from In Vitro Fertilization (IVF) are not different in fertile, sterilized patients compared to infertile women: A Society for Assisted Reproductive Technology (SART) database analysis.Fertil Steril. 2021; 115: 617-626Abstract Full Text Full Text PDF Scopus (2) Google Scholar) was designed with the goal of helping answer this question. The underlying hypothesis of their study was predicated on the idea that comparing women without true infertility undergoing ART with those with infertility would help resolve this debate. In doing so, they hoped to tease out whether obstetric outcomes were related to the manipulation of gametes and/or the artificial hormonal environment created as part of ART and, if there was such a relationship, what was the degree of the relationship. To help answer this question, the authors compared outcomes from fresh nondonor cycles between a cohort of women with prior tubal ligation as the only indication for in vitro fertilization and those with other infertility diagnoses. Answering this question is of clear importance to the field. If adverse outcomes are in fact due to the technology itself, at a minimum, this would require changing the way patients are counseled regarding risks. It should also prompt further investigation and funding into understanding the drivers of any undesirable outcomes in the hope that they can be mitigated. The old adage that in order to solve a problem, first you must acknowledge that the problem exists, holds true in this setting. The association of preterm birth and low birth weight with the use of ART is well established; however, the underlying cause is not agreed upon. The fact that subfertile couples who conceive spontaneously also have a higher risk of preterm labor and low birthweight argues in favor of the importance of underlying patient factors (2Declercq E. Luke B. Belanoff C. Cabral H. Diop H. Gopal D. et al.Perinatal outcomes associated with assisted reproductive technology: the Massachusetts Outcomes Study of Assisted Reproductive Technologies (MOSART).Fertil Steril. 2015; 103: 888-895Abstract Full Text Full Text PDF PubMed Scopus (115) Google Scholar). In order to assess the validity of the current study, first we need to reflect upon what is known more generally about the underlying causes of preterm birth and its incidence. According to the American College of Obstetricians and Gynecologists Practice Bulletin Number 130 on “Prediction and Prevention of Preterm Birth,” approximately 12% of all live births occur before term. This quoted incidence is higher than those in the control populations of many of the studies comparing ART with spontaneous conceptions listed in the references of the authors’ manuscript (approximately 4% to 8%), but similar to the incidence in the ART population in their study. As with many conditions in medicine, one of the biggest predictors of preterm birth is a history of prior preterm birth. Unfortunately, this is a variable that is not recorded in the Society for Assisted Reproductive Technology (SART) database. Other variables known to impact preterm birth and low birthweight include age >35 years, higher body mass index, and higher parity. All of these factors were statistically significantly greater in the “fertile” group. Although Libby et al. appropriately controlled for these factors, there are still limitations. Parity, for example, is recorded as 0, 1, or 2+ in the SART database used, which fails to differentiate between a woman who is a G2P2 from one who is a G5P5. Since nearly 60% of women who have successfully undergone tubal ligation have had four or more children (3Zite N. Wuellner S. Gilliam M. Failure to obtain desired postpartum sterilization: risk and predictors.Obstet Gynecol. 2005; 105: 794-799Crossref PubMed Scopus (51) Google Scholar), this is a valid concern, given that the risk of preterm birth has been shown to be elevated in both nulliparous women and women in their fifth pregnancy (4Koullali B. van Zijl M.D. Kazemier B.M. Oudijk M.A. Mol B.W.J. Pajkrt E. et al.The association between parity and spontaneous preterm birth: a population based study.BMC Pregnancy Childbirth. 2020; 20: 233-1-233-8Crossref Scopus (20) Google Scholar). Additionally, given the significant discrepancy between the number of patients included in the “fertile” and “infertile” groups (2.2% vs. 97.8%), the authors could have attempted to match the fertile group with some of these key variables (age, body mass index, and parity); this might have resulted in comparable case numbers and more comparable control groups. Another concern is in regard to the Libby et al.'s original hypothesis that “fertile” couples undergoing ART would have improved perinatal outcomes compared with “infertile” women. The underlying premise of this hypothesis relies on the assumption that one group is truly “fertile” and the other is truly “infertile.” Interestingly, the very basis of the hypothesis is not supported by objective evidence. One would expect that a “fertile” group would have a higher pregnancy rate than a group labeled “infertile.” However, the clinical pregnancy and live birth rates were actually 1% higher in the “infertile” group. This result raises the question of whether a “fertile” group was truly identified. It may very well be that a history of prior tubal ligation is not sufficient to separate fertile from infertile women, whether due to omission of other diagnoses or to other variables not accounted for in the SART database. An example of this is endometriosis, for which there is increasing evidence that it is an independent risk factor for adverse pregnancy outcomes such as preterm delivery (5Zullo F. Spagnolo E. Saccone G. Acunzo M. Xodo S. Ceccaroni M. et al.Endometriosis and obstetrics complications: a systematic review and meta-analysis.Fertil Steril. 2017; 108: 667-672.e5Abstract Full Text Full Text PDF PubMed Scopus (117) Google Scholar). It is not known what percentage of “infertile” patients in Libby et al.'s study had endometriosis. The SART Cross-Origin Resource sharing (CORS) database, like any other large database, is subject to a certain degree of inaccuracy because of its size and the nature of the reporting structure. Although the overall accuracy of the SART database has been validated, certain areas of the report have shown mixed success. It is reasonable to speculate that diagnoses of the “fertile” and “infertile” groups may not be thoroughly documented or not consistently entered into SART. The lack of completeness or accuracy of the diagnoses may further obscure the results of this study. When viewed through this lens, the overall results seem less certain. The absence of a difference in preterm birth and low birth weight rates between the tubal ligation (fertile) and infertile groups does at first glance raise concern that the ART process itself is responsible for the increased incidence of these outcomes. However, the absence of a difference between the clinical pregnancy and live birth rates between the groups calls this conclusion into question, largely because it calls into question whether the first group can accurately be characterized as “fertile.” It may very well be that there is a set of underlying and unaccounted for patient variables that can explain why the fertility rate of the “infertile” group appears to be similar to, if not slightly better than, that of the “fertile” group. The question then remains whether these same variables are responsible for similar outcomes with regard to preterm birth and low birth weight as well. Hence, the debate about whether it is the patient or the process is likely to continue. Obstetric outcomes in pregnancies resulting from in vitro fertilization are not different in fertile, sterilized women compared to infertile women: A Society for Assisted Reproductive Technology database analysisFertility and SterilityVol. 115Issue 3PreviewTo compare obstetric and neonatal outcomes resulting from assisted reproductive technology in couples with a history of female sterilization to couples with other infertility diagnoses. Full-Text PDF" @default.
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• W3134765870 title "Preterm birth: is it the patient or the process?" @default.
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