Fertility

The basic concern of every fertility professional today is to reduce time-to-pregnancy, enhance live birth rate and ensure future good health of the child. In this quest, various fertility interventions are appended to prevailing assisted reproductive technology (ART) protocols. The use of add-ons has been a debatable issue since their suitability and long-term benefits still need to be ascertained. As such the question arises whether it is morally and ethically right to impart such treatment modalities which have neither been adequately tested on animals, nor on donated human embryos; where proper systematic randomized clinical trials (RCTs) have yet to be conducted in appropriate human study populations [1] and most importantly when such tests/techniques are provided at additional (often exorbitant) costs without giving the patient a clear idea of ‘evidence of no benefits’ or worse still, ‘lack of evidence’ at all! It may be argued that what applies to animals does not necessarily extrapolate to humans and that the first use of IVF technique was actually an add-on to natural conception, introduced without any RCT (although justified on the basis of larger signal-to-noise ratio) [2]! Another pertinent point to ponder upon is the fact that often it is the desperate-toconceive, ready-to-pay, internet-enlightened intelligentsia that prod the doctor to use latest technology despite being made aware of only observational benefits of interventions. Although request for use of a particular procedure may fall within the ambit of patient autonomy and rights, it is also expected that the treating specialists use their discretion to refuse appeals for such scientifically unverified techniques. The temptation to apply any unproven remedy under the garb of ‘patient demand’ must be strictly avoided. At this juncture, the role of adequate counselling may play a key role. A good counselling session with the couple may go a long way in removing any ambiguity and paving way for a transparent doctor-patient communication. In the UK, the Human Fertilization and Embryology Authority (UK-HFEA) mandates providing strong clinical evidence and information on the costs incurred, to the patient before starting any add-on treatment [3]. However, patients often look up hospital websites before embarking on treatment. An appraisal of IVF centre websites across the UK and the USA, revealed that in gross violation of the Health on the Net Code and American Medical Association (AMA) guidelines respectively, most of them were promoting experimentally unverified interventions at additional costs without citing relevant references to backup claims of their effectiveness [4]. To quote an example from this study, regarding use of assisted hatching (AH) technique, a website claimed (quote): “This creates a weak spot which makes it easier for the embryo inside to ‘hatch’ and implant in your womb. If the embryo cannot escape from the zona, it will never be able to implant no matter how good it is. ” (unquote). As per that study, 14 fertility centres in the UK claimed benefit of use of AH but only one centre quantified the claim and that too was backed up with a single relevant citation. Similarly, 24 centres advocated the use of ICSI but just 50% of them quantified their claim whereas none cited any references in support of the benefits. In all, of the 276 claims made by 74 websites, only 29% enumerated the benefits and most of them supported those by quoting the same specific references. The pathetic scenario in countries lacking regulatory bodies may then well be imagined [4]. Having said that, effectiveness of add-ons like dehydroepiandrosterone (DHEA) supplementation to poor responders [5, 6], metformin for polycystic ovarian syndrome (PCOS) [7], GnRh agonist trigger to prevent ovarian hyperstimulation syndrome (OHSS) in donor-recipient cycles [8], and embryo glue [9] are being largely accepted owing to promising, beneficial results in certain classified category of patients. Add-ons like time-lapse, pre-implantation genetic screening (PGS), and sperm DNA fragmentation analyses * Bindu N. Chimote bindunm10@yahoo.com