Are we really offering our patients a significant, strong and positive intervention or are we just playing with biological randomness?
Clinical medicine is an array of decision-making. We can assume the approach is similar for IVF. In order to decide, a medical question must be precisely formulated. Then, in order to provide an answer we can either resort to personal and empirical information from observations that seem to have worked, the so-called “personal and empirical medicine”, or to data from the “evidence-based medicine”. The later, derivative of randomized controlled trials (CRTs), is the pure scientific approach.
What are those CRTs? Scientists/doctors select large numbers of patients with a certain medical question/problem.. To “tame” biological randomness they divide these patients randomly in 2 groups. In one group they blindly apply the technique or treatment in question, and in the other group they make no interventions. An independent researcher measures and edits the outcomes. In the end they report, whether the technique/treatment statistically significantly improved or compromised the measured outcome, or it made no difference at all. Statistical significance means that the outcome was truly affected by our intervention and was not a result of randomness. Our treatments really matter. CRT studies must be well designed and have the proper number of patients in each group to have the power to reveal a meaningful difference. A technique/treatment that has been verified by CRTs can therefore be utilized. In other words, are we really offering our patients a significant, strong and positive intervention or are we just playing with biological randomness?
Interventions that are not evidence-based effective ultimately do not change the outcome
If we cannot beat randomness, it is much better not to do anything, but to explain to our patients all aspects, saving them time, money, treatment side effects, expectations and negative emotions. Interventions that are not evidence-based effective ultimately do not change the outcome. Whatever changes are observed are a random effect.
An ethical or even legal question might be raised. Is it ethical or legal for the patient to pay for a non-evidenced-based technique/treatment? Is it better to educate our patients, properly explaining that we have no truly effective interventions and in turn either not do anything or consent to a personal and empirical approach?
To discuss an example; Aiming for higher success rates in IVF, an endometrial injury or “scratch” has been proposed. Many studies and metanalyses of poor and moderate quality showed conflicting results. However, a lot of fertility clinicians perform endometrial “scratches” which is a relatively invasive procedure and charge for it. In January 2019, S Lensen et al., in the New England Journal of Medicine, published a CRT of endometrial scratching performed before IVF. They showed that endometrial scratching did not result in a higher rate of live birth even in cases of repeated IVF failures. It was a large, well-designed study that had the power to detect differences as of 7%. Having such data it is very difficult to justify this intervention before IVF even for those with repeated failure in implantation.
Is it ethical or legal for
the patient to pay for a
Unfortunately, we not always have proper CRTs to support clinical decisions. In such cases, we may resort to empirical medicine techniques/treatments, but we must be very cautious about possible side effects and expectations, and we must inform patients in detail and ask for their understanding and consent.
People undergoing IVF are very vulnerable. They should not be exploited. When we have the privilege and opportunity to apply evidence-based medicine, we must apply it.