Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000094875
Ethics application status
Approved
Date submitted
4/12/2020
Date registered
1/02/2021
Date last updated
16/06/2022
Date data sharing statement initially provided
1/02/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Follow up study of children conceived following a lipiodol HSG (hysterosalpingogram)
Scientific title
Growth, body composition and developmental assessment of children conceived following a lipiodol hysterosalpingogram
Secondary ID [1] 302903 0
None
Universal Trial Number (UTN)
U1111-1262-2521
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive development 319911 0
Condition category
Condition code
Neurological 317856 317856 0 0
Studies of the normal brain and nervous system
Reproductive Health and Childbirth 317857 317857 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Exposure group are children who were conceived within 6 months of their mother having a hysterosalpingogram with Lipiodol dye. This is a cross-sectional study, the outcomes (cognitive development, growth and body composition) will be measured in one sitting. The duration of a single session is approximately 3 hours.
Intervention code [1] 319189 0
Not applicable
Comparator / control treatment
The control group are between 6-14 years old, they are the siblings of children in the exposure group. The control group have been born without any assisted reproductive technology.
Control group
Active

Outcomes
Primary outcome [1] 325860 0
Cognitive development assessed via WISC IV
Timepoint [1] 325860 0
Single study visit (all primary and secondary outcomes will be measured in one sitting)
Secondary outcome [1] 389363 0
Height assessed via Harpenden stadiometer,

Timepoint [1] 389363 0
Single study visit
Secondary outcome [2] 389364 0
Body composition (including lean mass, fat free mass, fat mass, body mass, bone mineral density and bone mineral content) assessed via DEXA machine (composite secondary outcome).
Timepoint [2] 389364 0
Single study visit
Secondary outcome [3] 390290 0
Blood pressure measured with a standard mercury sphygmomanometer.
Timepoint [3] 390290 0
Single study visit
Secondary outcome [4] 390291 0
Weight measured with a Wedderburn VM206 scale.
Timepoint [4] 390291 0
Single study visit.

Eligibility
Key inclusion criteria
Exposure group: Children who are aged between 6-14 years, and have been conceived within 6 months of their mother receiving lipiodol hysterosalpingogram (HSG).

Control group: children who are aged between 6-14 years and are siblings of a child in the exposure group. They have been conceived without any assisted reproductive technology.
Minimum age
6 Years
Maximum age
14 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Overt, pre-existing developmental delay.
Chronic illness that can impact on developmental assessment.
Medication known to affect neurocognitive outcome such as anti-depressives, methylphenidate etc.
A history of recreational drug use including tobacco and alcohol.
Known bone fragility disorders or medical conditions that could affect bone density.
Twins conceived following lipiodol.

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
We plan to recruit 50 children between 6-14 years old and compare the cognitive development, growth and body composition and compare these parameters with a control group derived from siblings.
A clinically meaningful difference in a full scale WISC developmental assessment is between 5-10 DQ points.
To determine a 6 DQ point difference in a WISC developmental assessment between the two groups with an SD of 10 and a power of 80%, 40 subjects are required in each group, We plan to test 50 to account for dropouts.


Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/06/2023
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment outside Australia
Country [1] 23234 0
New Zealand
State/province [1] 23234 0

Funding & Sponsors
Funding source category [1] 307323 0
University
Name [1] 307323 0
Research grant administered by the Liggins Institute at the University of Auckland
Country [1] 307323 0
New Zealand
Primary sponsor type
University
Name
University of Auckland, office of research strategy and integrity
Address
85 park road
Grafton
Auckland 1023
Country
New Zealand
Secondary sponsor category [1] 307961 0
None
Name [1] 307961 0
Address [1] 307961 0
Country [1] 307961 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307413 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 307413 0
133 Molesworth Street
Thorndon
Wellington 6011
New Zealand
Ethics committee country [1] 307413 0
New Zealand
Date submitted for ethics approval [1] 307413 0
Approval date [1] 307413 0
02/02/2021
Ethics approval number [1] 307413 0
20/CEN/225

Summary
Brief summary
This is a part of a larger study evaluating various safety aspects of an infertility investigation, namely Lipiodol hysterosalpingogram (HSG). Hysterosalpingograms are commonly used by fertility doctors to assess if the fallopian tubes have blockages. Lipiodol is an iodine rich dye used in these assessments. Lipiodol HSGs have been performed for over 100 years, however their popularity increased lately as recent research showed that Lipiodol increased pregnancy rates by around 40%.
Lipiodol HSGs have been relatively safe and well tolerated. Some studies have shown that iodine excess and mild underactivity of thyroid gland (subclinical hypothyroidism) could occur following Lipiodol HSG for a short period.
As more children are born following Lipiodol HSG, the long term health of these children needs confirming, especially with respect to growth, puberty, development and body composition. Unlike childhood outcomes from other assisted reproductive techniques, there have been no studies thus far to assess the long term outcome of offspring born following Lipiodol HSG. This is where this study comes into play, If the long term safety is ascertained, more infertile couples could benefit from Lipiodol HSG.
We plan to recruit 50 children between 6-14 years old who have been conceived within 6 months of their mother having had a Lipiodol HSG and compare their growth, body composition and development with siblings who were conceived without any assisted reproduction or fertility enhancement techniques.
While any effect, even if present, is likely to be subtle, this is an important safety check to do. On the other hand, there may be some unexpected benefits or differences which could guide medical management.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 107150 0
Prof Paul Hofman
Address 107150 0
Private Bag 92019
Liggins Institute
University of Auckland
Auckland 1142
Country 107150 0
New Zealand
Phone 107150 0
+64 21938 897
Fax 107150 0
Email 107150 0
[email protected]
Contact person for public queries
Name 107151 0
Prof Paul Hofman
Address 107151 0
Private Bag 92019
Liggins Institute
University of Auckland
Auckland 1142
Country 107151 0
New Zealand
Phone 107151 0
+64 21938 897
Fax 107151 0
Email 107151 0
[email protected]
Contact person for scientific queries
Name 107152 0
Prof Paul Hofman
Address 107152 0
Private Bag 92019
Liggins Institute
University of Auckland
Auckland 1142
Country 107152 0
New Zealand
Phone 107152 0
+64 21938 897
Fax 107152 0
Email 107152 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9896Study protocol  [email protected]
9897Ethical approval  [email protected]
9898Informed consent form  [email protected]



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.