None listed
Conditions
Brief summary
This is primarily a safety study of an infertility investigation that has been performed since the 1920s. This infertility investigation called hysterosalpingogram (HSG) is a radiology study where radio-opaque dye is injected into the uterus to establish anatomy and the patency of both fallopian tubes. Recently it has been shown that using a fat soluble dye (lipiodol) as the contrast agent in HSG increases the pregnancy rates in unexplained infertility up to 40% in the following 6 months. Though Lipiodol had been in use for a century, the recent confirmation that fertility is substantially increased after these procedures has increased interest in performing these procedures as an intervention for infertility. However, Lipiodol dye contains very large amounts of iodine and if the dye spills into the abdomen it can be released over several months, potentially causing toxicity for the mother and fetus. This is primarily due to the effect of iodine excess on thyroid function and small studies have suggested that there are changes in thyroid function, both in the women and neonates conceived within a few cycles following a Lipiodol HSG. This project aims to 1) Investigate the effects of thyroid function in the women and establish protocols to ensure normal thyroid function in those having thyroid function abnormalities. 2) Establish which women are most at risk of these problems. 3)Investigate the effect on thyroid function in the offspring conceived within the six months following the HSG.
Interventions
We recruit women who undergo hysterosalpingogram(HSG) using Lipiodol dye as part of their infertility work up . Lipiodol is an oil soluble dye rich in iodine and had been in use for a century with increased use in last 20 years due to additional therapeutic benefit of increased pregnancy rates.
After screening, eligible participants are recruited for SELFI trial after informed consent.They undergo blood and urine test in the community lab before the HSG and serially for 6 months after the proc
We recruit women who undergo hysterosalpingogram(HSG) using Lipiodol dye as part of their infertility work up . Lipiodol is an oil soluble dye rich in iodine and had been in use for a century with increased use in last 20 years due to additional therapeutic benefit of increased pregnancy rates. After screening, eligible participants are recruited for SELFI trial after informed consent.They undergo blood and urine test in the community lab before the HSG and serially for 6 months after the procedure. The investigations are done by the phlebotomist in the local community labs. This involves 8 lab visits over a period of 6 months.The thyroid results are chased by the research team and informed to the fertility doctor and participant. A record is made if thyroid replacement is initiated by the primary fertility doctor. A documentation is made if the participant gets pregnant during the study period. No additional blood or urine tests will be performed on these women beyond the study duration by the research team. However, relevant investigations (eg.thyroid function test) will be passed on to the treating doctor for ongoing care. If the woman conceives during the study period of 6 months, the newborn's thyroid test is done on seventh day of life. This is by a heel prick test at the community lab or by a home visit by the phlebotomist as per parent's preference. Results are chased by the research team. If any thyroid hormone replacement necessary and started by the paediaric team, a record is kept. In addition, the radiologist who does the Lipiodol HSG keeps a record of Lipiodol volume used. The Xray films are independently read by reaserch team radiologist to assesss peritoneal spill and they are blinded to the urine iodine levels. These data are used at the analysis to correlate if increased peritoneal retention of Lipiodol correlates with iodine excess and thyroid dysfunction.
Sponsors
Liggins Institute,University of Auckland
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Any woman of the reproductive age group who is going for a Lipiodol HSG if they have 1. Normal thyroid function demonstrated by normal free T4 2. Subjects with subclinical hypothyroidism (defined as a TSH >97th percentile or 2.5 IU/L and normal Free T4 levels) are included.
Exclusion criteria
1. Subject taking medication known to affect thyroid function or iodine metabolism (e.g. Lithium, amiodarone etc.) 2. Active thyroid disease including hyperthyroidism, hypothyroidism, thyroid cancer and benign goitre. 3. A previous radiological dye study within the last 3months for aqueous dyes and6months for fat soluble dyes as this will affect urine iodine interpretation.
Outcome results
None listed