{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,30]],"date-time":"2026-05-30T00:21:50Z","timestamp":1780100510560,"version":"3.54.0"},"reference-count":20,"publisher":"MDPI AG","issue":"23","license":[{"start":{"date-parts":[[2023,11,24]],"date-time":"2023-11-24T00:00:00Z","timestamp":1700784000000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/501100001826","name":"ZonMw","doi-asserted-by":"publisher","award":["849200009"],"award-info":[{"award-number":["849200009"]}],"id":[{"id":"10.13039\/501100001826","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["IJERPH"],"abstract":"<jats:p>Paternal medication use around the time of conception is common, but information about its effects on pregnancy outcome and the health of the child is generally limited. The aim of this study is to examine the feasibility of studying paternal exposure in the Dutch Pregnancy Drug Register by using immunosuppressants as a proof of concept. In 113 of 15,959 pregnancies, long-term paternal immunosuppressant use was reported 3 months before conception. In total, 134 immunosuppressants were used. Pregnancy outcome was known for 54 cases and was in accordance with previous findings. Two spontaneous abortions, two premature births, six small for gestational age babies, and two major congenital malformations were reported. Time to pregnancy (TTP) was known for 9548 pregnancies, including 89 with paternal immunosuppressant use. TTP analysis did not show a difference in pregnancies with paternal immunosuppressant use compared to the control group. Moreover, the number of fertility treatments in the paternal immunosuppressant group was similar to the control group. In our opinion, it is feasible to use the Dutch Pregnancy Drug Register to study the effects of paternal exposure on pregnancy outcome. However, to study the potential effects on fertility, more information is needed, particularly since the beginning of pregnancy attempts.<\/jats:p>","DOI":"10.3390\/ijerph20237107","type":"journal-article","created":{"date-parts":[[2023,11,24]],"date-time":"2023-11-24T03:54:35Z","timestamp":1700798075000},"page":"7107","update-policy":"https:\/\/doi.org\/10.3390\/mdpi_crossmark_policy","source":"Crossref","is-referenced-by-count":6,"title":["The Dutch Pregnancy Drug Register: Suitable to Study Paternal Drug Exposures?"],"prefix":"10.3390","volume":"20","author":[{"given":"Annerose E.","family":"van der Mijle","sequence":"first","affiliation":[{"name":"Netherlands Pharmacovigilance Centre Lareb, 5237 MH Hertogenbosch, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1010-7373","authenticated-orcid":false,"given":"Petra J.","family":"Woestenberg","sequence":"additional","affiliation":[{"name":"Netherlands Pharmacovigilance Centre Lareb, 5237 MH Hertogenbosch, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Leanne J.","family":"Kosse","sequence":"additional","affiliation":[{"name":"Netherlands Pharmacovigilance Centre Lareb, 5237 MH Hertogenbosch, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Eug\u00e8ne P.","family":"van Puijenbroek","sequence":"additional","affiliation":[{"name":"Netherlands Pharmacovigilance Centre Lareb, 5237 MH Hertogenbosch, The Netherlands"},{"name":"Groningen Research Institute of Pharmacy, PharmacoTherapy\u2014Epidemiology & Economics, University of Groningen, 9713 AV Groningen, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"1968","published-online":{"date-parts":[[2023,11,24]]},"reference":[{"key":"ref_1","doi-asserted-by":"crossref","first-page":"609","DOI":"10.1002\/pds.959","article-title":"Drug use among fathers around time of conception: Two register based surveys from Denmark and The Netherlands","volume":"13","author":"Schirm","year":"2004","journal-title":"Pharmacoepidemiol. Drug Saf."},{"key":"ref_2","doi-asserted-by":"crossref","first-page":"513","DOI":"10.1517\/14740338.2012.674109","article-title":"Paternal drug use: Before and during pregnancy","volume":"11","author":"Crijns","year":"2012","journal-title":"Expert Opin. Drug Saf."},{"key":"ref_3","doi-asserted-by":"crossref","first-page":"860","DOI":"10.1002\/bdra.23556","article-title":"Changing of the guards: EMA warning on paternal use of mycophenolate mofetil: An unnecessary and insufficiently substantiated precaution","volume":"106","author":"Damkier","year":"2016","journal-title":"Birth Defects Res. A Clin. Mol. Teratol."},{"key":"ref_4","doi-asserted-by":"crossref","first-page":"561","DOI":"10.1097\/MIB.0000000000001064","article-title":"The Influence of Methotrexate Treatment on Male Fertility and Pregnancy Outcome After Paternal Exposure","volume":"23","author":"Grosen","year":"2017","journal-title":"Inflamm. Bowel Dis."},{"key":"ref_5","doi-asserted-by":"crossref","first-page":"192","DOI":"10.1093\/humupd\/dmx034","article-title":"The associations of thiopurines with male fertility and paternally exposed offspring: A systematic review and meta-analysis","volume":"24","author":"Simsek","year":"2018","journal-title":"Hum. Reprod. Updat."},{"key":"ref_6","doi-asserted-by":"crossref","first-page":"176","DOI":"10.1111\/j.1742-7843.2007.00162.x","article-title":"Evidence for a role of paternal exposures in developmental toxicity","volume":"102","author":"Cordier","year":"2008","journal-title":"Basic Clin. Pharmacol. Toxicol."},{"key":"ref_7","doi-asserted-by":"crossref","first-page":"640","DOI":"10.1111\/andr.12366","article-title":"The impact of drugs on male fertility: A review","volume":"5","author":"Semet","year":"2017","journal-title":"Andrology"},{"key":"ref_8","doi-asserted-by":"crossref","first-page":"77","DOI":"10.1016\/j.bpobgyn.2019.09.004","article-title":"Paternal safety of anti-rheumatic medications","volume":"64","author":"Bermas","year":"2020","journal-title":"Best Pract. Res. Clin. Obstet. Gynaecol."},{"key":"ref_9","doi-asserted-by":"crossref","first-page":"161","DOI":"10.1002\/(SICI)1096-9926(199909)60:3<161::AID-TERA12>3.0.CO;2-A","article-title":"Teratogen update: Paternal exposures-reproductive risks","volume":"60","author":"Trasler","year":"1999","journal-title":"Teratology"},{"key":"ref_10","doi-asserted-by":"crossref","first-page":"213","DOI":"10.1016\/j.reprotox.2015.10.015","article-title":"Potential seminal transport of pharmaceuticals to the conceptus","volume":"58","author":"Scialli","year":"2015","journal-title":"Reprod. Toxicol."},{"key":"ref_11","doi-asserted-by":"crossref","first-page":"961","DOI":"10.1093\/humupd\/dmaa022","article-title":"The effect of paternal exposure to immunosuppressive drugs on sexual function, reproductive hormones, fertility, pregnancy and offspring outcomes: A systematic review","volume":"26","author":"Dolhain","year":"2020","journal-title":"Hum. Reprod. Updat."},{"key":"ref_12","doi-asserted-by":"crossref","first-page":"107","DOI":"10.1053\/j.gastro.2021.03.020","article-title":"Paternal Exposure to Immunosuppressive and\/or Biologic Agents and Birth Outcomes in Patients with Immune-Mediated Inflammatory Diseases","volume":"161","author":"Meserve","year":"2021","journal-title":"Gastroenterology"},{"key":"ref_13","doi-asserted-by":"crossref","first-page":"1","DOI":"10.1007\/s40264-018-0722-7","article-title":"Aim and Design of pREGnant, the Dutch Pregnancy Drug Register","volume":"42","author":"Vorstenbosch","year":"2019","journal-title":"Drug Saf."},{"key":"ref_14","unstructured":"Perined (2023, July 03). The Perinatal Registry of The Netherlands. Geboortegewichtcurven. Available online: https:\/\/www.perined.nl\/geboortegewichtcurven."},{"key":"ref_15","unstructured":"European Commission (2023, July 03). EUROCAT Guide 1.5. Available online: https:\/\/eu-rd-platform.jrc.ec.europa.eu\/eurocat\/data-collection\/guidelines-for-data-registration_en."},{"key":"ref_16","unstructured":"European Commission (2023, July 03). EUROCAT Data. Prevalence Charts and Tables. Available online: https:\/\/eu-rd-platform.jrc.ec.europa.eu\/eurocat\/eurocat-data\/prevalence_en."},{"key":"ref_17","unstructured":"Perined (2023, July 03). The Perinatal Registry of The Netherlands. Kerncijfers, 2021. Available online: https:\/\/www.perined.nl\/onderwerpen\/publicaties-perined\/kerncijfers-2021."},{"key":"ref_18","first-page":"783","article-title":"The Use of Medication in Pregnancy","volume":"116","author":"Dathe","year":"2019","journal-title":"Dtsch. Arztebl. Int."},{"key":"ref_19","doi-asserted-by":"crossref","first-page":"179","DOI":"10.5468\/ogs.2018.61.2.179","article-title":"Clinical assessment of the male fertility","volume":"61","author":"Khatun","year":"2018","journal-title":"Obstet. Gynecol. Sci."},{"key":"ref_20","first-page":"906","article-title":"Use of real-world evidence from healthcare utilization data to evaluate drug safety during pregnancy","volume":"28","author":"Huybrechts","year":"2019","journal-title":"Drug Saf."}],"container-title":["International Journal of Environmental Research and Public Health"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/www.mdpi.com\/1660-4601\/20\/23\/7107\/pdf","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,10,10]],"date-time":"2025-10-10T21:28:57Z","timestamp":1760131737000},"score":1,"resource":{"primary":{"URL":"https:\/\/www.mdpi.com\/1660-4601\/20\/23\/7107"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,11,24]]},"references-count":20,"journal-issue":{"issue":"23","published-online":{"date-parts":[[2023,12]]}},"alternative-id":["ijerph20237107"],"URL":"https:\/\/doi.org\/10.3390\/ijerph20237107","relation":{},"ISSN":["1660-4601"],"issn-type":[{"value":"1660-4601","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,11,24]]}}}