Infertility Injection Use Rises 1.4x in 5 Years, But Evidence and Efficacy Remain Insufficient

The use of Intralipid, an injectable treatment for infertility, has surged by 1.5 times in South Korea over the past five years, with annual supplies averaging 2.5 billion won. Despite its increased application in assisted reproduction for patients with recurrent miscarriage or implantation failure, a recent analysis by the Korea Health Industry Development Institute reveals a significant lack of sufficient evidence and efficacy.

“

Domestic clinical practice is using Intralipid injections, but the medical evidence and international recommendations supporting it are still insufficient.

An examination of 11 international clinical practice guidelines published in the last decade showed that seven did not recommend Intralipid or explicitly stated that the evidence was insufficient. This trend is particularly pronounced in guidelines published after 2020. While three randomized controlled trials suggested a slight increase in clinical pregnancy rates, the evidence level was low. Conversely, one non-randomized study indicated a significantly higher miscarriage rate in the Intralipid group, alongside some concerns regarding safety, including congenital malformations and pregnancy complications.

“

We need to strengthen shared decision-making, transparently explaining the current uncertain evidence level and potential risks to patients.

Despite these findings, a survey of 70 South Korean obstetricians revealed that 54.3% prescribe Intralipid empirically, citing expectations of good outcomes and minimal side effects. However, those who do not prescribe it (32 respondents) pointed to unclear treatment effects as their reason. Among 177 patients who received Intralipid treatment, the primary reason for choosing it was physician recommendation (63.3%).

“

This study is meaningful in that it confirmed the real-world usage of an infertility treatment that has been widely used without clear evidence, using national data for the first time.

Park Dong-ah, a senior researcher at the Korea Health Industry Development Institute, emphasized that while Intralipid is used in clinical practice, the supporting medical evidence and international recommendations remain insufficient. He stressed the need to strengthen shared decision-making, ensuring patients are fully informed about the uncertain evidence, potential risks, and costs. Lee Jae-tae, president of the institute, highlighted the study's significance in confirming the real-world usage of the infertility drug despite its uncertain evidence base, vowing to promote evidence-based practice in collaboration with relevant academic societies.

“

Moving forward, we will continue to promote evidence-based clinical practice in cooperation with relevant academic societies.