None listed
Conditions
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.
Interventions
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.
Sponsors
University of Auckland, office of research strategy and integrity
Eligibility
Sex/Gender
All
Age
6 Years to 14 Years
Healthy volunteers
Yes
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.
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.
Outcome results
None listed