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Neurocognitive DisordersNeuro-H2OilNCT05168228

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

An observational study of Neurocognitive Disorders, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 5 to 10 years
Conditions the study is for
Neurocognitive Disorders
What is being tested?
Oil- versus waterbased contrast in hysterosalpingography (HSG)
Type of treatment
Surgery or procedure
How many people
64 participants
Where
1 siteNetherlands
Study dates
26 Jan 2022to 1 Aug 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 10 years
  • All sexes
  • No healthy volunteers
  • Child

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).

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Emma Kinderziekenhuis

    Amsterdam, North Holland

Other trials in Netherlands

About this study

Official title: Evaluating the Long-term Neurocognitive Effects of Preconceptional Exposure to Iodinated Contrast During Hysterosalpingography (HSG) on the Offspring of the H2Oil Trial

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.

Read the detailed description

Background: Iodinated contrast is commonly used in hysterosalpingography (HSG), a diagnostic tool in fertility work-up. Yet excessive iodine may pool for a long time in the body, crosses the placenta easily, and can induce hypothyroidism in both mothers and foetuses. Inadequate supplies of thyroid hormones have previously been associated with neurocognitive impairments in offspring. Considering the widespread use of iodinated contrast during fertility work-up, the potential iatrogenic effect of preconceptional iodine exposure on the brain development of the offspring needs to be addressed urgently.

Objectives: This project 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. To do this, the investigators will follow up on a cohort of offspring conceived during the H2Oil randomised controlled trial (NTR 3270), which was set up to evaluate the effect of using water- or oil-based media during HSG on pregnancy rates.

Methods: The study team have previously obtained parental permission for follow-up research in 140 children conceived during the H2Oil study <6 months after exposure to iodine during the HSG. The investigators will conduct comprehensive an in-depth outcome assessment of intelligence, neurocognitive development, school performance, and behavioural functioning.

Relevance: Using this diverse range of methods, the investigators expect to be the first to shed light on the long-term iatrogenic consequences of using iodinated contrast just before conception on the neurodevelopment of their offspring. The findings of this study will have implications for current clinical practice, where HSG is readily used in subfertile women, and will be used to inform the Dutch guidelines for fertility work-up.

Being tested
Oil- versus waterbased contrast in hysterosalpingography (HSG)
Keywords
Hysterosalpingography, Iodinated contrast media, Iodine, Intelligence, Neurocognitive development
Medical subject headings
Neurocognitive Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Oil- versus waterbased contrast in hysterosalpingography (HSG)Procedure or surgery

    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).

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

    Measured: 1 Day

  3. 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.

    Measured: 1 Day

  4. 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.

    Measured: 1 Day

Secondary outcomes (6)

  1. Visuomotor integration

    Visuomotor integration will be assessed using a Track \& Trace task of the Emma Toolbox for Neurocognitive Functioning, which is an in-house designed battery of computerised tests for assessing different neurocognitive domains.

    Measured: 1 Day

  2. Processing & Control

    Processing \& Control will be assessed using an Attention Network Test of the Emma Toolbox for Neurocognitive Functioning, which is an in-house designed battery of computerised tests for assessing different neurocognitive domains.

    Measured: 1 Day

  3. Visual Memory

    Visual Memory will be assessed using an Location Learning Test of the Emma Toolbox for Neurocognitive Functioning, which is an in-house designed battery of computerised tests for assessing different neurocognitive domains.

    Measured: 1 Day

  4. Verbal Memory

    Verbal Memory will be assessed using a Rey Auditory Verbal Learning Test (Dutch Version) of the Emma Toolbox for Neurocognitive Functioning, which is an in-house designed battery of computerised tests for assessing different neurocognitive domains.

    Measured: 1 Day

  5. Visual Working Memory

    Visual Working Memory will be assessed using a Klinberg task of the Emma Toolbox for Neurocognitive Functioning, which is an in-house designed battery of computerised tests for assessing different neurocognitive domains.

    Measured: 1 Day

  6. Verbal Working Memory

    Verbal Working Memory will be assessed using a Digit Span task of the Emma Toolbox for Neurocognitive Functioning, which is an in-house designed battery of computerised tests for assessing different neurocognitive domains.

    Measured: 1 Day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Dec 2021
  2. Study start26 Jan 2022
  3. Primary completion1 Jul 2022 (estimated)
  4. Study completion1 Aug 2022 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
64 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05168228
Sponsor's protocol ID
2021.0448
Acronym
Neuro-H2Oil
Status last verified
Jan 2022
First submitted
25 Nov 2021
Last updated
27 Jan 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 34365200

  • 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.

    PubMed 28520519

  • 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.

    PubMed 39198011

Questions about this trial

What is this clinical trial studying?

An observational study of Neurocognitive Disorders, run by Amsterdam UMC, location VUmc at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 27 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

School performance (time frame: Between the ages of 4-12, up to 12 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05168228, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2022.

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