Autor/es reacciones

Francisco Domínguez

Research Coordinator at the IVI Foundation and Head of the Reproductive Biology and Bioengineering in Human Reproduction Group at IISLaFe

Does the press release accurately reflect the study?

“Broadly speaking, yes. The press release correctly conveys the study’s main message: for most of the add-ons used in assisted reproduction, there is no solid evidence that they improve the likelihood of a live birth, and much of the available literature has significant methodological limitations. It also accurately reflects that some procedures, such as endometrial scratching, PICSI or EmbryoGlue, show signs of a possible benefit, albeit with varying degrees of uncertainty and also depending heavily on the patients in whom these add-ons are used.”

Is the study of good quality? Are the conclusions supported by robust data?

“Yes. This is a methodologically robust study that systematically reviews 85 randomised clinical trials on ten different add-ons. The authors applied very strict criteria for quality and reliability, excluding approximately half of the potentially eligible studies due to methodological problems or doubts about their reliability. Furthermore, they used internationally recognised tools such as GRADE to assess the quality of the evidence. However, the strength of the conclusions depends on each intervention. For some add-ons, the evidence is moderate, whilst for others it remains low or very low due to the small size of the available studies or the risk of bias”.

How does this study fit in with the existing evidence?

“The results are, in general, consistent with previous systematic reviews and Cochrane reviews. The main novelty is that the authors apply stricter criteria to assess the reliability of clinical trials and update the evidence by incorporating new studies published in recent years. Despite excluding numerous studies previously included in other reviews, the overall conclusions remain largely unchanged, which reinforces the robustness of the findings. This study also reflects a growing trend in evidence-based medicine: it is not enough simply to accumulate studies; it is essential to critically assess their methodological quality and reliability.”

Have the authors taken confounding factors into account? Are there any important limitations to bear in mind?

“Yes. The authors carried out heterogeneity analyses, risk-of-bias assessments and sensitivity analyses. Furthermore, they took into account factors such as the patients’ age, the presence of repeated implantation failure, and the use of placebo controls or sham procedures where possible. Among the main limitations, it is worth noting that many of the available trials are small, are at risk of bias, or were conducted years ago using IVF protocols that no longer fully reflect current clinical practice. Furthermore, for some interventions, the evidence remains scarce or highly uncertain. The authors themselves acknowledge that some excluded studies may contain valid data, even though they did not meet current standards of reliability.”

What are the implications for real-world practice?

“The main implication is that patients and reproductive medicine professionals should exercise caution before incorporating costly or invasive complementary treatments that have not clearly been shown to improve the likelihood of having a live newborn at home. The results should not be interpreted as marking the end of research in this field. Some add-ons show promising signs and could be beneficial in certain patient groups, but larger and more rigorous clinical trials are needed to determine precisely who might actually benefit from these interventions.

As a reproductive specialist, I would add an important caveat: the absence of solid evidence does not always equate to evidence of a lack of benefit. In many cases, it simply means that we do not yet have sufficiently robust studies to provide a definitive answer to the question.”

EN