Potential association between infertility and spinal neural tube defects in offspring

Wu, Yvonne W.; Croen, Lisa; Henning, Louis H.; Najjar, Daniel V.; Schembri, Michael; Croughan, Mary S.

doi:10.1002/bdra.20313

Cited by 31 publications

(26 citation statements)

References 35 publications

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“…Their data suggest that there might be a slight and probable indirect association between the use of CC and NTD. Recently, Wu et al (12) found an OR of 11.7 (95% CI 2.0-44.8) for NTD with the use of CC within the window spanning 60 days before to 15 days after conception. The number of CC cycles in the 12 months before conception was higher in mothers with infants with NTDs than in control mothers (mean 5.7 vs. 2.6 cycles, P¼.01).…”

Section: Clomiphene Citratementioning

confidence: 97%

Drugs in infertility and fetal safety

Elizur

Tulandi

2008

Fertility and Sterility

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Section: Clomiphene Citratementioning

confidence: 97%

Drugs in infertility and fetal safety

Elizur

Tulandi

2008

Fertility and Sterility

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“…Across cohort and case-control studies there is no evidence that exposure to clomiphene citrate (G03GB02) in the periconceptional period increases the rate of all CAs combined. There is conflicting evidence of an association with NTDs [135][136][137]. Clomiphene has been associated with coarctation of the aorta [66,138], anencephaly, Dandy Walker malformation, septal heart defects, muscular ventricular septal defects, esophageal atresia, cloacal exstrophy, craniosynostosis and omphalocele but multiple comparisons and small numbers of cases make these findings tentative [66].…”

Section: G03gbmentioning

confidence: 99%

EUROmediCAT signal detection: an evaluation of selected congenital anomaly‐medication associations

Given

Loane

Luteijn

et al. 2016

Brit J Clinical Pharma

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AimsTo evaluate congenital anomaly (CA)‐medication exposure associations produced by the new EUROmediCAT signal detection system and determine which require further investigation.MethodsData from 15 EUROCAT registries (1995–2011) with medication exposures at the chemical substance (5th level of Anatomic Therapeutic Chemical classification) and chemical subgroup (4th level) were analysed using a 50% false detection rate. After excluding antiepileptics, antidiabetics, antiasthmatics and SSRIs/psycholeptics already under investigation, 27 associations were evaluated. If evidence for a signal persisted after data validation, a literature review was conducted for prior evidence of human teratogenicity.ResultsThirteen out of 27 CA‐medication exposure signals, based on 389 exposed cases, passed data validation. There was some prior evidence in the literature to support six signals (gastroschisis and levonorgestrel/ethinylestradiol (OR 4.10, 95% CI 1.70–8.53; congenital heart disease/pulmonary valve stenosis and nucleoside/tide reverse transcriptase inhibitors (OR 5.01, 95% CI 1.99–14.20/OR 28.20, 95% CI 4.63–122.24); complete absence of a limb and pregnen (4) derivatives (OR 6.60, 95% CI 1.70–22.93); hypospadias and pregnadien derivatives (OR 1.40, 95% CI 1.10–1.76); hypospadias and synthetic ovulation stimulants (OR 1.89, 95% CI 1.28–2.70). Antipropulsives produced a signal for syndactyly while the literature revealed a signal for hypospadias. There was no prior evidence to support the remaining six signals involving the ordinary salt combinations, propulsives, bulk‐forming laxatives, hydrazinophthalazine derivatives, gonadotropin releasing hormone analogues and selective serotonin agonists.ConclusionSignals which strengthened prior evidence should be prioritized for further investigation, and independent evidence sought to confirm the remaining signals. Some chance associations are expected and confounding by indication is possible.

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“…Since then, additional case–control and cohort studies have found controversial results. In particular, in 2006, a case–control study conducted in the Kaiser permanent claims database found an association between CC exposure in pregnancy and an increased risk of NTDs …”

Section: Introductionmentioning

confidence: 99%

“…In particular, in 2006, a case-control study conducted in the Kaiser permanent claims database found an association between CC exposure in pregnancy and an increased risk of NTDs. 6 The aim of this study is to provide an up-to-date metaanalysis evaluating the association between periconceptional CC exposure and the risk of NTDs.…”

Section: Introductionmentioning

confidence: 99%

Clomiphene citrate and neural tube defects: a meta‐analysis of controlled observational studies

Auffret

Cottin

Vial

et al. 2019

BJOG

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Background At the end of the 1980s, several studies suggested a potential increased risk of neural tube defects (NTDs) with ovulation induction/fertility drugs, especially with clomiphene citrate (CC). A previous meta‐analysis of observational studies evaluating the risk of NTDs associated with the use of CC performed in 1995 found a risk ratio of 1.08 (95% CI 0.76–1.51). Since then, additional studies have been published and the risk of NTDs associated with periconceptional CC exposure may have changed. Objective To perform an updated quantitative meta‐analysis of the risk of NTDs associated with periconceptional CC exposure. Search strategy MEDLINE, Web of Science, and Scopus were searched (October 2018). Selection criteria Comparative cohort and case–control studies investigating the risk of NTDs after periconceptional CC exposure. Data collection and analysis Pooled effect sizes with corresponding 95% CIs were calculated using random effects models, comparing the risk of NTDs between pregnancies exposed and not exposed to CC. Main results Thirteen studies met the inclusion criteria, totalling 218 819 pregnancies. Periconceptional exposure to CC was not significantly associated with an increased risk of NTDs (pooled odds ratio 1.21, 95% CI 0.88–1.66). No heterogeneity between studies was observed (I2 = 26%). A funnel plot and asymmetry test were not suggestive of publication bias. Conclusion Our meta‐analysis confirms that exposure to CC before or in early pregnancy was associated with a 21% increased risk of NTD in relation to CC exposure; however, this increased risk is not statistically significant. Tweetable abstract A new meta‐analysis finds that clomiphene citrate exposure before or in early pregnancy is not associated with an increased risk of NTDs.

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Potential association between infertility and spinal neural tube defects in offspring

Abstract: Background-To examine the possible association between infertility and spinal neural tube defects.

Cited by 31 publications

References 35 publications

Drugs in infertility and fetal safety

Drugs in infertility and fetal safety

EUROmediCAT signal detection: an evaluation of selected congenital anomaly‐medication associations

Clomiphene citrate and neural tube defects: a meta‐analysis of controlled observational studies

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