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Evaluating the Long-term Neurocognitive Effects of Preconceptional Exposure to Iodinated Contrast on the Offspring

NCT05168228 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 64

Last updated 2022-01-27

No results posted yet for this study

Summary

Iodinated contrast is commonly used in hysterosalpingography (HSG), a diagnostic tool in fertility work-up. This study aims to investigate the safety of contrast media used during HSG by evaluating the long-term effects on the neurodevelopment of offspring 6-8 years after exposure to iodinated contrast media.

Conditions

  • Neurocognitive Disorders

Interventions

PROCEDURE

Oil- versus waterbased contrast in hysterosalpingography (HSG)

The Neuro-H2Oil study looks at the offspring of the H2Oil study, a randomized controlled trial (RCT) comparing hysterosalpingography (HSG) with oil- versus water-based contrast during fertility work-up. For more information please see NTR 3270 (original H2Oil study), www.trialregister.nl. The control group is the Database for Controls in Neuroscience Studies (D-CNS), registered as NL9574 (https://www.trialregister.nl/trial/9574).

Sponsors & Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    collaborator OTHER

  • Amsterdam UMC, location VUmc

    lead OTHER

Principal Investigators

  • Marsh Königs, PhD · Emma Children's Hospital, Amsterdam UMC

Eligibility

Min Age
5 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-26
Primary Completion
2022-07-01
Completion
2022-08-01

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05168228 on ClinicalTrials.gov