Use of clomiphene citrate and birth defects, National Birth Defects Prevention Study, 1997–2005

J Reefhuis; M.A Honein; L.A Schieve; S.A Rasmussen; National Birth Defects Prevention Study

doi:10.1093/humrep/deq313

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Use of clomiphene citrate and birth defects, National Birth Defects Prevention Study, 1997–2005

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Use of clomiphene citrate and birth defects, National Birth Defects Prevention Study, 1997–2005

J Reefhuis, M.A Honein, L.A Schieve, S.A Rasmussen and National Birth Defects Prevention Study

Human reproduction (Oxford), Vol.26(2), pp.451-457

02/2011

DOI: 10.1093/humrep/deq313

PMID: 21112952

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Abstract

BACKGROUND Clomiphene citrate (CC) is the first line drug for subfertility treatment. Studies assessing the association between CC and birth defects have been inconclusive. METHODS We used data from the National Birth Defects Prevention Study, a population-based, multi-site case–control study of major birth defects. Women from 10 US regions with deliveries affected by at least one of >30 birth defects (cases) and mothers of live born infants without a major birth defect (controls) who delivered October 1997–December 2005 were interviewed. The exposure of interest was reported CC use in the period from 2 months before conception through the first month of pregnancy. Women who conceived using assisted reproductive technology were excluded. Thirty-six birth defect categories with at least three exposed cases were studied. Multiple logistic regression was used to control for potential confounders. RESULTS CC use was reported by 1.4% of control mothers (94/6500). Among 36 case-groups assessed, increased adjusted odds ratios (aOR) were found [all: aOR, 95% confidence interval (CI)] for anencephaly (2.3, 1.1–4.7), Dandy–Walker malformation (4.4, 1.7–11.6), septal heart defects (1.6, 1.1–2.2), muscular ventricular septal defect (4.9, 1.4–16.8), coarctation of aorta (1.8, 1.1–3.0), esophageal atresia (2.3, 1.3–4.0), cloacal exstrophy (5.4, 1.6–19.3), craniosynostosis (1.9, 1.2–3.0) and omphalocele (2.2, 1.1–4.5). CONCLUSIONS Several associations between CC use and birth defects were observed. However, because of the small number of cases, inconsistency of some findings with previous reports, and the fact that we cannot assess the CC effect separately from that of the subfertility, these associations should be interpreted cautiously.

clomiphene citrate

congenital malformations

ovulation stimulation

birth defects

Details

Title: Subtitle: Use of clomiphene citrate and birth defects, National Birth Defects Prevention Study, 1997–2005
Creators: J Reefhuis - National Center on Birth Defects and Developmental Disabilities
M.A Honein - National Center on Birth Defects and Developmental Disabilities
L.A Schieve - National Center on Birth Defects and Developmental Disabilities
S.A Rasmussen - National Center on Birth Defects and Developmental Disabilities
National Birth Defects Prevention Study
Contributors: Paul A Romitti (Contributor) - University of Iowa, Epidemiology
Resource Type: Journal article
Publication Details: Human reproduction (Oxford), Vol.26(2), pp.451-457
DOI: 10.1093/humrep/deq313
PMID: 21112952
NLM abbreviation: Hum Reprod
ISSN: 0268-1161
eISSN: 1460-2350
Publisher: Oxford University Press
Language: English
Date published: 02/2011
Academic Unit: Epidemiology; Biostatistics
Record Identifier: 9984214662002771

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