NCT05168228

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 25, 2021

Completed
28 days until next milestone

First Posted

Study publicly available on registry

December 23, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

January 26, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

January 27, 2022

Status Verified

January 1, 2022

Enrollment Period

5 months

First QC Date

November 25, 2021

Last Update Submit

January 26, 2022

Conditions

Neurocognitive Disorders

Keywords

HysterosalpingographyIodinated contrast mediaIodineIntelligenceNeurocognitive development

Outcome Measures

Primary Outcomes (4)

  • School performance

    Longitudinal data on school performance will be collected using standardised tests from the pupil monitoring system developed by the Dutch National Institute for Educational Measurement (CITO-test). CITO-tests are used to assess children's academic performance (reading comprehension, spelling, and arithmetic performance) in primary schools in the Netherlands.

    Between the ages of 4-12, up to 12 years

  • Intelligence

    General intelligence will be assessed using a shortened Fifth version of the Wechsler Intelligence Scale for Children. Full-scale IQ (FSIQ) will be estimated using the subtests Vocabulary, Similarities, Matrix Reasoning, and Block Design.

    1 Day

  • Behavioural functioning evaluated through the Strengths and Difficulties Questionnaire (SDQ).

    Behavioural functioning will be evaluated through the Strengths and Difficulties Questionnaire (SDQ). Both parents and teachers will fill in the SDQ.

    1 Day

  • Behavioural functioning evaluated through the Strengths and Weaknesses of ADHD Symptoms And Normal behaviour (SWAN) scale.

    Behavioural functioning will be evaluated will be evaluated using the Strengths and Weaknesses of ADHD Symptoms And Normal behaviour (SWAN) scale. Both parents and teachers will fill in the SWAN scale.

    1 Day

Secondary Outcomes (6)

  • Visuomotor integration

    1 Day

  • Processing & Control

    1 Day

  • Visual Memory

    1 Day

  • Verbal Memory

    1 Day

  • Visual Working Memory

    1 Day

  • +1 more secondary outcomes

Interventions

Oil- versus waterbased contrast in hysterosalpingography (HSG)PROCEDURE

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).

Eligibility Criteria

Age5 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children born to mothers who participated in the original H2Oil study (NTR3270), a multicentre randomised controlled trial on oil- versus water-based HSG in 2012-2014 whose parents gave consent to be contacted for follow up studies (n=140).

You may qualify if:

  • Children conceived after the mother underwent HSG procedure in the context of the H2Oil trial (2012-2014)
  • Children must be conceived \<6 months after the HSG procedure
  • Parents must have given consent for recontacting for follow up research

You may not qualify if:

  • Children conceived after the mother underwent HSG procedure that was not part of the H2Oil trial
  • Children conceived \>6 months after the HSG procedure
  • Children whose parents did not give permission to be recontacted for follow up research
  • Children that are not able to comprehend the instructions at the time of assessment
  • Absence or withdrawal of written informed consent
  • Inability to comprehend testing instructions at time of assessment
  • Severe motor disability that interferes with outcome assessment at time of assessment
  • Documented and/or parent-reported diagnosis of a neurological disorder
  • Somatic disorders known to affect the outcome assessments at time of assessment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emma Kinderziekenhuis

Amsterdam, North Holland, Netherlands

Location

Related Publications (3)

  • Konigs M, Verhoog EM, Oosterlaan J. Exploring the neurocognome: Neurocognitive network organization in healthy young adults. Cortex. 2021 Oct;143:12-28. doi: 10.1016/j.cortex.2021.06.011. Epub 2021 Jul 14.

    PMID: 34365200BACKGROUND

  • Dreyer K, van Rijswijk J, Mijatovic V, Goddijn M, Verhoeve HR, van Rooij IAJ, Hoek A, Bourdrez P, Nap AW, Rijnsaardt-Lukassen HGM, Timmerman CCM, Kaplan M, Hooker AB, Gijsen AP, van Golde R, van Heteren CF, Sluijmer AV, de Bruin JP, Smeenk JMJ, de Boer JAM, Scheenjes E, Duijn AEJ, Mozes A, Pelinck MJ, Traas MAF, van Hooff MHA, van Unnik GA, de Koning CH, van Geloven N, Twisk JWR, Hompes PGA, Mol BWJ. Oil-Based or Water-Based Contrast for Hysterosalpingography in Infertile Women. N Engl J Med. 2017 May 25;376(21):2043-2052. doi: 10.1056/NEJMoa1612337. Epub 2017 May 18.

    PMID: 28520519BACKGROUND

  • Keestra SM, Van Welie N, Dreyer K, Van Eekelen R, Roseboom TJ, Oosterlaan J, Mol BW, Finken MJJ, Mijatovic V, Konigs M. Neurodevelopmental outcomes of school-age children conceived after hysterosalpingography with oil-based or water-based iodinated contrast: long-term follow-up of a nationwide randomized controlled trial. Hum Reprod. 2024 Oct 1;39(10):2287-2296. doi: 10.1093/humrep/deae183.

    PMID: 39198011DERIVED

MeSH Terms

Conditions

Neurocognitive Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

  • Marsh Königs, PhD

    Emma Children's Hospital, Amsterdam UMC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor in Obstetrics and Gynaecology, Specialist in Reproductive Medicine, Head of Endometriosis Center VUmc

Study Record Dates

First Submitted

November 25, 2021

First Posted

December 23, 2021

Study Start

January 26, 2022

Primary Completion

July 1, 2022

Study Completion

August 1, 2022

Last Updated

January 27, 2022

Record last verified: 2022-01

Locations

NL(1)