ANZCTR - Registration

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With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

None

Universal Trial Number (UTN)

U1111-1262-2521

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Cognitive development

Condition category

Condition code

Neurological

Studies of the normal brain and nervous system

Reproductive Health and Childbirth

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]

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]

Cognitive development assessed via WISC IV

Timepoint [1]

Single study visit (all primary and secondary outcomes will be measured in one sitting)

Secondary outcome [1]

Height assessed via Harpenden stadiometer,

Timepoint [1]

Single study visit

Secondary outcome [2]

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]

Single study visit

Secondary outcome [3]

Blood pressure measured with a standard mercury sphygmomanometer.

Timepoint [3]

Single study visit

Secondary outcome [4]

Weight measured with a Wedderburn VM206 scale.

Timepoint [4]

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]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

University

Name [1]

Research grant administered by the Liggins Institute at the University of Auckland

Address [1]

Liggins Institute The University of Auckland Private Bag 92019 Victoria Street West Auckland 1142 New Zealand

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Central Health and Disability Ethics Committee

Ethics committee address [1]

133 Molesworth Street
Thorndon
Wellington 6011
New Zealand

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

Approval date [1]

02/02/2021

Ethics approval number [1]

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

Prof Paul Hofman

Address

Private Bag 92019 Liggins Institute University of Auckland Auckland 1142

Country

New Zealand

Phone

+64 21938 897

Fax

[email protected]

Contact person for public queries

Name

Paul Hofman

Address

Private Bag 92019 Liggins Institute University of Auckland Auckland 1142

Country

New Zealand

Phone

+64 21938 897

Fax

[email protected]

Contact person for scientific queries

Name

Paul Hofman

Address

Private Bag 92019 Liggins Institute University of Auckland Auckland 1142

Country

New Zealand

Phone

+64 21938 897

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

What supporting documents are/will be available?

Doc. No.	Type	Email
9896	Study protocol	[email protected]
9897	Ethical approval	[email protected]
9898	Informed 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.

Trial Review

Documents added manually

Documents added automatically