Patient acceptance of Self-Operated Endovaginal Telemonitoring (SOET): proof of concept

Initial attempts at obtaining a pregnancy by in vitro fertilization and embryo transfer (IVF-ET) were conducted in a natural cycle (Edwards et al., 1980). It soon became clear that ovarian stimulation using gonadotropins provided a useful tool to obtain more oocytes and increase the chance for success. This resulted in the need to monitor ovarian stimulation, based on serial sonographic assessments of follicular growth and to a lesser degree on serial measurements of serum estradiol (Golan et al., 1994; Lass, 2003). Estradiol measurements became less important and are now considered to be of value mainly in cases of threatening ovarian hyperstimulation syndrome (OHSS). Serial sonography as a sole method of monitoring follicular growth has become routine and cannot be dispensed with, both for optimal timing of HCG administration and for early detection of threatening OHSS. Development of patient-friendly IVF includes self-administration of gonadotropins, milder stimulation protocols (Baart et al., 2007), reduction of multiple pregnancies by single embryo transfer (Gerris et al., 2002) and less ovarian hyperstimulation syndrome, more efficacious embryo freezing programs (Tiitinen et al., 2004) and less treatment-induced stress. Natural cycles or minimally modified natural cycles have been suggested (Pelinck et al., 2008) to further minimize the impact of IVF treatment on patients’ daily life. In vitro maturation (IVM) also minimizes gonadotropin use (Soderstrom-Anttila et al., 2006). Still one major inconvenience persists i.e. the need for women to frequently visit the clinic to perform serial vaginal sonographies. Although no hard data exist, in our own centre, the last one hundred in-house attempts needed 440 follicular phase sonograms, i.e. a mean of 4,4 per fresh treatment cycle. The total annual number of IVF/ICSI cycles amounts to ~one million and is rising. Another one million of non-IVF/ICSI stimulations should be added. This implies eight to ten million annual sonographic examinations for pre-ovulatory monitoring only or, for ~300 working days per year, a daily trek to the IVF clinic for 90,000 women! In addition, huge distances in large countries where sonography is not available in reasonable distance from homes decreases access to treatment for many couples who need it. This is the case in large developed societies e.g. the USA, Australia, Canada, but also in many third-world and emerging countries where services used to be relatively scarce but are now quickly growing, e.g. the BRIC countries. The possibility for patients to perform vaginal sonographies themselves at home includes theoretical advantages. Patients need not to come as often to the centre to have sonographies performed. They will save time and money spent on petrol, car usage, train or bus. They and their partners will avoid loss of income during working hours. Weekends with their important social and household functions will not be interrupted by trips to the centre. IVF centres will be less crowded during morning hours. Measurements will be standardized and reproducible and performed at ease, hence will be of a better quality. Communication with the patient will be smoother, more complete and explicitly contain all information. Images can be accompanied by questions that can be answered properly and not in a hurry by a stressed doctor, midwife or nurse. Sonograms can be made by the partner who is often the “cause” of the infertility and in many cases will be happy to participate in an active way. Time will become available for necessary interactions between doctors/nurses and patients who truly need to come physically to the centre, reducing excessively long waiting lists for consultations. Treatments will become possible in patients living far from the centre allowing them to show up just before egg retrieval from anywhere in the world. It is a development that fits in a flat world where telemedicine has already found a place in other fields of medicine e.g. radiology, cardiology, cardiotocography, etc. SOET could have a place in IVF treatment in the third world where several women in rural areas can have sonograms made through the use of a single instrument, data being to a central monitoring unit. Even if applicable to a selected proportion of IVF patients, SOET could perfectly fit in the general tendency to make IVF more patient-friendly and to increase patient empowerment by supervised active participation to the treatment (Saltman, 1994). It could fit in a politically desired trend to pay fixed amounts for professional efforts that can be organized and standardized using service level agreements. This would be in line with how other aspects of ART treatment are financed in Belgium (laboratory phase: 1,283€; gonadotrophins: 1,073€; oocyte pick-up: 591€; and embryo transfer: 155€). The idea is to have patients have their sonographies perform themselves, after proper instruction by a midwife or a nurse-practitioner, using a small, safe, cheap and easy-to-use device, allowing registration of real time images under direct visual inspection of the patient or her partner. Images can be sent with proper identification over the internet to the centre where specialized personnel and technology receives, stores, analyzes and interprets the images and takes swift appropriate action. Analysis and response could be semi-automated using specific new software applications. They comprise proper instructions regarding the dose of gonadotropins to be self-injected during the following day(s), the timing for a subsequent sonogram, the precise timing of HCG injection and of oocyte retrieval. If extended to intrauterine insemination or freeze/thaw cycles after IVF, even in a natural cycle or after oral ovulation induction, planning of insemination or embryo replacement can be communicated. If needed, these self-operated endovaginal sonographies (SOETs) can be performed with a backup of same-day (if needed) or next-day “live” sonography in the centre. Many secondary questions and considerations will need to be addressed, a.o. (re)organisational aspects, protection of privacy, legal and financial aspects, the impact of failure from the patients’ side to correctly apply the technology, etc. It is not the idea to replace all vaginal sonography in the context of IVF, let alone all gynaecological sonography, by SOET. “Real” sonography will remain a very important tool in IVF, and even if implemented, SOET will not replace sonography in complicated cases, when follicular growth is abnormally slow or quick, when abnormal images (cysts, hydrosalpinges, unexpected tumours, endometriosis, etc.) are observed, or on simple request from anxious patients. It is conceived in the first place to alleviate an abnormal amount of routine and to allow patients living far from the centre to demand less sacrifices. We wanted to find out whether patients would in general welcome the possibility to perform vaginal sonograms themselves, whether images recorded by one person would result in the same clinical decisions when analysed by another person and finally whether patients are also able to actually produce good quality video recordings of their internal genital organs.