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Caiyun Liao: Evaluating the Efficacy of RCTs in Reproductive Health
Caiyun Liao/LinkedIn
Jan 5, 2026, 15:21

Caiyun Liao: Evaluating the Efficacy of RCTs in Reproductive Health

Caiyun Liao, Assistant Professor at UMass Memorial Health, shared a post by Antonio Gargiulo, Medical Director of Advanced Reproductive Surgery at Fertility Centers of New England, on LinkedIn:

“I would add- not all RCTs are created equal. However, we face the problem of people feeling over-confident about their assertions simply because ‘there is an RCT for that’.

Take the issue of uterine septum and recurrent pregnancy loss (RPL) as an example. The widely cited RCT by Rikken et al. (PMID: 33793794) are limited by a few issues: (1) The initial intention was to recruit only those with RPL; inclusion criteria were then expanded to include those with ‘subfertility, pregnancy loss, and preterm delivery’, which are very different conditions. (2) Randomization was not stratified by these vastly different conditions and therefore might have been imbalanced. (3) Power calculation was based on the assumption that live birth would increase from 35% to 70%. But in my opinion, unless one focuses on the RPL population, it’s unlikely to observe dramatic effect as such. In other words, the power calculation was problematic, and the study might have been underpowered, especially if the true question is the value of septoplasty in the context of RPL.

To compound these problems, limited studies are then pulled into systematic reviews; meta-analyses are often done even though the heterogeneity of the studies means they should not be pooled to draw a summarized effect size. But again, systematic reviews and meta-analyses of RCTs are often touted as the highest level of evidence, even though this assumption only holds true if the analysis is held to the rigorous standards.

I applaud colleagues for taking on the arduous task of conducting RCTs. But to provide valid answers to the questions, we need clearly defined inclusion criteria, proper randomization (and stratification if necessary), and good statistical analysis. And yes, when RCTs are not available, well-conducted large cohort studies should not be brushed off as irrelevant.”

Quoting Antonio Gargiulo’s, Medical Director of Advanced Reproductive Surgery at Fertility Centers of New England, post:

“I love this one: reposting a week late thanks to my taking a holiday break from LinkedIn (a workplace social network).

The cartoon is awesome!

Randomized trials matter when genuine equipoise exists and when they are designed to answer questions that cannot be answered otherwise. When randomization becomes ritual rather than necessity, it risks turning ethically empty, exposing patients to burden in service of methodological dogma. Well-designed observational studies, grounded in deep clinical expertise and real-world practice, often better serve patients, truth, and medicine itself.

Less ritual. More relevance.”

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Advanced Reproductive Techniques Antonio Gargiulo Caiyun Liao Clinical Trial Limitations Fertility Fertility Challenges Fertility News Patient Recruitment pregnancy loss Recurrent Pregnancy Loss Reproductive Surgery Surgical Interventions Uterine Health Uterine Septum
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