Post-Conceptional Exposure to Clomiphene Citrate and Congenital Malformations: A Cohort Study

Rebeccah Nehard, Catherine Vauzelle, Delphine Beghin, Mathilde Latour, Elisabeth Elefant, Bénédicte Coulm and Benoît Marin ()
Additional contact information
Rebeccah Nehard: Sorbonne Université, Inserm, Institut Pierre-Louis d’épidémiologie et de Santé Publique, AP-HP, hôpital Trousseau, Département de Santé Publique, Centre de Référence sur les Agents Tératogènes (CRAT)
Catherine Vauzelle: AP-HP Sorbonne Université, Hôpital Trousseau, Département de Santé Publique, Centre de Référence sur les Agents Tératogènes (CRAT)
Delphine Beghin: AP-HP Sorbonne Université, Hôpital Trousseau, Département de Santé Publique, Centre de Référence sur les Agents Tératogènes (CRAT)
Mathilde Latour: AP-HP Sorbonne Université, Hôpital Trousseau, Département de Santé Publique, Centre de Référence sur les Agents Tératogènes (CRAT)
Elisabeth Elefant: AP-HP Sorbonne Université, Hôpital Trousseau, Département de Santé Publique, Centre de Référence sur les Agents Tératogènes (CRAT)
Bénédicte Coulm: Sorbonne Université, Inserm, Institut Pierre-Louis d’épidémiologie et de Santé Publique, AP-HP, hôpital Trousseau, Département de Santé Publique, Centre de Référence sur les Agents Tératogènes (CRAT)
Benoît Marin: Sorbonne Université, Inserm, Institut Pierre-Louis d’épidémiologie et de Santé Publique, AP-HP, hôpital Trousseau, Département de Santé Publique, Centre de Référence sur les Agents Tératogènes (CRAT)

Drug Safety, 2024, vol. 47, issue 9, No 6, 883-894

Abstract: Abstract Background Clomiphene citrate is an ovulation inductor for which inadvertent post-conceptional exposures may occur in early pregnancy. In preclinical studies, post-conceptional exposures showed a teratogenic effect in different species. In humans, to date, little is known about the outcomes of inadvertently post-conceptionally exposed pregnancies. Objectives The objectives of our study were to assess the association between post-conceptional exposures to clomiphene citrate and major and minor congenital malformations in the offspring. Methods A retrospective cohort study of prospectively ascertained cases was undertaken, based on clinical data from the Centre de Référence sur les Agents Tératogènes (CRAT), Paris, France. Women with post-conceptional exposure to clomiphene citrate (n = 309), and unexposed pregnant women (n = 1236, 1:4 ratio) with prospectively collected data, known pregnancy outcome and delivery date prior to 01/02/2022, were matched by calendar year. An adjudication committee classified major and minor congenital malformations according to the EUROCAT (European Registration of Congenital Anomalies and Twins) classification. Results Among post-conceptional exposed women, no increased risk of major malformation was found (crude relative risk = 0.64, 95% confidence interval 0.19–2.15) as compared to unexposed women. Three major and ten minor congenital malformations were reported in the exposed group. An increased risk of minor malformations was found (crude relative risk = 4.05, 95% confidence interval 1.70–9.64) although there was no specific clinical pattern. Conclusions Post-conceptional exposure to clomiphene citrate was not associated with an increased risk of major congenital malformations. Given potential confounding and information biases, the results about minor malformations should be interpreted with caution as no specific clinical pattern was identified.

Date: 2024
References: View complete reference list from CitEc
Citations:

Downloads: (external link)
http://link.springer.com/10.1007/s40264-024-01438-0 Abstract (text/html)
Access to the full text of the articles in this series is restricted.

Related works:
This item may be available elsewhere in EconPapers: Search for items with the same title.

Export reference: BibTeX RIS (EndNote, ProCite, RefMan) HTML/Text

Persistent link: https://EconPapers.repec.org/RePEc:spr:drugsa:v:47:y:2024:i:9:d:10.1007_s40264-024-01438-0

Ordering information: This journal article can be ordered from
http://www.springer.com/adis/journal/40264

DOI: 10.1007/s40264-024-01438-0

Access Statistics for this article

Drug Safety is currently edited by Nitin Joshi

More articles in Drug Safety from Springer
Bibliographic data for series maintained by Sonal Shukla () and Springer Nature Abstracting and Indexing ().