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Oil-Based or Saline Contrast for Sono-HSG in Infertile Women: A Pilot Randomized Controlled Double Blind Trial

Open AccessPublished:November 14, 2022DOI:https://doi.org/10.1016/j.xfre.2022.11.005
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      ABSTRACT

      Objective

      To determine the feasibility, safety and outcomes of an oil-based, iodinated contrast using office-based, ultrasound-imaged hysterosalpingography (Sono-HSG) in women with infertility.

      Design

      Randomized Controlled Double Blind Clinical Trial.

      Setting

      Academic health center.

      Intervention(s)

      Tubal flushing with oil-based contrast medium (Lipiodol UF) vs saline.

      Main Outcome Measure(s)

      Ongoing pregnancy rate, pain, quality of life and thyroid function.

      Results

      48 patients (24 each group) were analyzed. The groups were well matched at baseline. Ongoing pregnancy was noted in 17% (4/24) of the oil contrast group vs 37% (9/24) in the saline group(P = 0.10). Saline group patients more frequently initiated infertility therapy in the 6 month follow-up period (Saline:67% vs Oil:33%, P = 0.02) and no serious adverse events in either group. There were no differences in pain from the procedure between groups. There were no differences in thyroid function tests post-procedure between groups, but within the oil contrast group there was a slight increase in TSH (post vs pre-ratio of geometric means: 1.18, 95% CI 1.02 to 1.38) and decrease in Free T4 (post vs pre difference in means: 0.08 ng/dL, 95% CI -0.14 to -0.01). Immediately after the test, doctors correctly guessed 79% of oil and 71% of saline randomization assignments; whereas, patients correctly guessed 63% of oil and 38% of saline.

      Conclusions

      This pilot study demonstrates safety and feasibility of giving an oil-based contrast medium during Sono-HSG. Pregnancies were seen after oil-based administration, and this contrast is associated with minor thyroid function impairment.

      Keywords