Several years ago the BBC programme Panorama presented an expose on the fertility industry’s use of add-ons (i.e. procedures that can be added to a routine IVF and ICSI treatment cycle). The majority are designed to help patients achieve and maintain a viable pregnancy and some have a sound scientific basis behind them, however not every patient will need any / every treatment, which is where the problem lies as many clinics charge for these additional procedures and back them up with various claims.
‘Oxford University's Centre for Evidence-Based Medicine examined the data on 27 methods. Only one, the endometrial scratching, was supported by scientific evidence. Practitioners, however, believe that there is plenty of anecdotal evidence supporting the use of these add-on treatments, but anecdotal evidence is not evidence-based medicine and this is where the disparity arises’ says Dr. Steven Green, fertility specialist and a founding father of IVF. ‘The only way to be confident that a treatment is effective enough to be used routinely is to carry out a large randomized controlled trial in which patients are assigned randomly to two groups: a treatment group and a control group. Ideally, several different groups of researchers should perform the same trial.’
The Human Fertilization and Embryology Authority (HFEA) is taking the issue very seriously. They believe that whilst some add-ons are beneficial, others are not, and alongside 10 of the UK’s leading professional and patient fertility groups are calling for better clarification and governance of the treatments. They have also added a list of the 10 most common treatments to their website, along with a traffic light colour system to illustrate each treatment’s effectiveness and safety, as measured by the available data.
Here are 10 of the most common add-ons that patients come across, and why they are used.
1. Time-lapse imaging of embryos. Designed to help embryologists identify abnormal growth in the developing embryo so that it can be excluded when selecting the embryo for the patient.
2. Embryo glue is a culture media, in which the embryo is incubated before being re-implanted in the patient’s uterus. It contains specific molecules that coat the embryo and increase the likelihood of a successful implantation.
3. Immunotherapy (reproductive immunology) treatments are designed to make potentially hostile implantation environments in some patients more favourable.
4. Endometrial scratching is believed to release chemicals that create a uterine environment that is more supportive for potential implantation. Several theories exist about how this is actually achieved.
5. Assisted hatching is a technique of chemical thinning or mechanical breaching designed to help embryos hatch out of abnormally thick shells and is performed before returning the embryo back to the patient.
6. Screening of eggs and embryos. There are several techniques available for this, all of which are designed to establish the presence of a normal set of chromosomes.
7. Freeze all cycles. Freezing all embryos and performing a thawed embryo transfer into a non-stimulated cycle can improve the chances of implantation.
8. Artificial egg activation. As soon as the sperm meets the egg, the egg is activated and responds by releasing calcium from internal storage. In some cases, however, the activation is unsuccessful. In this instance, artificial egg activation can help activate the egg. Using a calcium ionophore, we can stimulate an increase in calcium in the egg, improving the chance of fertilisation.
9. Intrauterine culture. During a conventional IVF cycle, eggs are fertilised and allowed to develop in a special culture fluid inside an incubator. Intrauterine culture differs in that it allows the early stages of embryo development to take place within the patient’s womb.
10. Sperm selection for ICSI. These are techniques to select sperm for ICSI based on the presence of a receptor on the sperm or on the shape of the sperm.
DO THEY WORK?
‘Although green signifies that more than one good quality randomised controlled trial has beenc conducted that proves the proceedure to be effective and safe, interestingly none of the 10 add-ons qualified’ says Dr. Green. ‘Six qualified as amber (artificial egg activation, freeze all cycles, embryo glue, endometrial scratching, embryo screening and time-lapse imaging) signifying that they have a small or conflicting body of evidence to support them, but require further research; and 4 were rated red (intrauterine culture, reproductive immunology, assisted hatching and sperm selection for ICSI), meaning that there is no evidence to show that the technique is effective or safe.’
The big question is: are the treatments not as successful as we think, or is it a case of there’s simpply not enough reaearch to show that they are beneficial? ‘It is likley to be the latter. However, which add-ons will benefit the patient will depend on the cause of the infertility. In reality the procedures will help some patients to successfully conceive, but it is important to understand what each procedure does so that, rather than being led by medical professionals, which is easy to do in a situation when all you desire is a baby, you can make an informed decision.’