Bath Fertility’s contribution to the results of the PIP-study
Bath Fertility was one of the UK centres involved in the PIP-study, an international randomised controlled trial looking into the effects of endometrial scratching on IVF treatment outcomes.
The results were presented at the 2018 ESHRE annual conference and caused quite a stir because the research showed there was no difference in pregnancy rates between women who had the scratch compared with those who did not. A brief overview of the results can be found here.
Our Senior Embryologist, Emma, was responsible for coordinating Bath Fertility’s involvement in the study. Following the release of the results people have been saying to her “You must be really disappointed with the results since you put so much time and effort into recruiting patients?” But Emma says, “I am delighted that we could make a contribution to this important research. The whole purpose of conducting clinical studies is to ensure that we are offering safe, effective treatments to our patients. We can only provide answers to these questions through this kind of research. The last thing we would want to do is recommend treatments that potentially have no benefit for our patients, which is why Bath Fertility are now no longer recommending endometrial scratch for our patients.”
Here Emma describes her experience of recruiting and monitoring patients for the PIP study.
“Before I could begin recruiting patients for the study in July 2016 I had several meetings with the Lead Study Coordinator Dr Sarah Lensen, and Dr Sarah Armstrong, the Local Study Investigator. I also had to attend a Good Clinical Practice (GCP) course which is mandatory for those involved with clinical research – the purpose of which was to give me all the information I needed to know about clinical research to ensure the rights, safety and dignity of research participants. It also helped ensure I was collecting the best quality of research data that I could.
My task was to seek out candidates and to give them all the information they needed to decide whether they would like to participate or not. This involved me checking a lot of medical records, reading all the clinical details and checking whether the woman met the eligibility criteria. If she did, I would indicate to the doctor seeing them for their appointment that the patient may be suitable for recruitment into the study. All in all I must have looked at well over 400 sets of medical records, and 240 patients were approached. Of those I spoke to I had make sure they fully understood what they were signing up for, as consent to a study is key and this was only completed after all information had been given and understood. Overall I managed to recruit 48 women.
I added patient data to a secure online database where the patient was randomly selected to have the procedure or not. There was a 50/50 chance for either outcome. Patients were often disappointed when I told them they had been randomised into the ‘no scratch’ group but were still understanding and were still happy to be contributing to the study as a whole. We stopped recruiting new patients at the end of May 2017, and to recruit 48 patients in under a year was a massive achievement for a clinic of our size which was recognised by the study coordinators.
Many people think that once you have randomly allocated a person into a study and they go on to have their procedure (or not) that’s where it stops. But in actual fact a study coordinator has to report on several things right up to a live birth. There began my endless phone calls and emails to our kind patients, from me asking if they could give me the results of their scans and then information on babies born as a result of treatment. This is also why it takes so long for results of a study looking into an IVF treatment to be published. Everyone was so patient and helpful and that made my job a lot easier. I am so grateful to all the women who participated.”
The written report of this study is due to be published in a peer-reviewed scientific journal in autumn 2018.