O-150 Birth defects reporting and the use of oral dydrogesterone in assisted reproductive technology : a global pharmacovigilance study

نویسندگان

چکیده

Abstract Study question Is dydrogesterone exposure during early pregnancy associated with the reporting of birth defects ? Summary answer We observed an increased defects, such as congenital heart and hypospadias, dydrogesterone, especially compared to progesterone use. What is known already In assisted reproductive technology (ART), intravaginal administration standard care overcome luteal phase deficiency induced by ovarian stimulation. recent years, Lotus I II randomized controlled clinical trials, demonstrated that oral a synthetic derivative, was non-inferior for rate at 12 weeks gestation could be alternative micronized vaginal (MVP). Safety profiles in both mother child were similar. However, concerns have been raised recently regarding association between usage disease offspring. design, size, duration performed case-non case study, similar concept case-control using international pharmacoviligance database, VigiBase. cohort consisted spontaneous reports pregnant women identified ad-hoc standardized query (SMQ “Pregnancy neonatal topics”). Birth defect cases containing term related “congenital, familial genetic disorders” System Organ Classes (SOCs) (excluding genetic, infectious metabolic abnormalities). Non-cases any other adverse drug reaction. Participants/materials, setting, methods Through case–non study conducted since database inception 12/31/2021, we first drug, then used ART. Secondly, comparison on progesterone. Results are presented odds ratio (ROR) their 95% confidence interval (95%CI). For each comparison, two sensitivity analyses performed. Main results role chance Among 29,120,563 individual safety reports, 50,653 use drugs Of these, 375 including 60 (16%) dydrogesterone. Dydrogesterone mostly reported from Europe (73%) physicians (82%). No teratogenic suspected onset 44 out (73.3%) compatible major (MBD) according EUROCAT classification. These contained total 55 MBD, consisting mainly genital hypospadias (n = 18, 32.7%), 15, 27.3%) limb 10, 18.2%) digestive system 6, 10.9%). primary analysis, significant disproportionate found when (ROR 5.4, 95%CI [3.9-7.6]) ART agent 5.9, [4.2-8.4]). head-to-head progesterone, [3.7-7.9]).These confirmed analyses. Limitations, reasons caution First, under-reporting, being inherent pharmacovigilance systems, impedes measurement incidence reaction can limit signal detection. Second, causality, not same all cases, challenging events requires further assessment. showed consistent results. Wider implications findings Physicians should aware this potential risk prescribing support. Further data needed confirm signal. Trial registration number Not applicable

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ژورنال

عنوان ژورنال: Human Reproduction

سال: 2023

ISSN: ['1460-2350', '0268-1161']

DOI: https://doi.org/10.1093/humrep/dead093.177