Trial of Lipiodol flushing

Neil Johnson MD interviewed by Deborah Bush QSM
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Deborah Bush QSM:  I am Deborah Bush, Chief Executive of the New Zealand Endometriosis Foundation and on the international advisory board for EndometriosisZone.org, and I am talking this afternoon to Neil Johnson.  

Neil is a Senior Lecturer at the University of Auckland, an obstetrician / gynaecologist at the National Women’s Hospital in Auckland, an REI Sub-Specialist with Fertility Plus and he is a gynaecologist at the University Specialists.  We are at the Ninth National Women’s Minimal Access Surgery Course, which is being held in conjunction with the Australian Gynaecologic Endoscopy Society at the Hilton Hotel in Auckland.   

Neil, I am really interested in the trial of Lipiodol flushing and I have noticed recently that it has had some media coverage on television in New Zealand and I would really like you to tell us a little bit about that because I believe you have also achieved some status with this trial and I would really like the listeners and readers of EndometriosisZone to know more about it. 

Dr Neil Johnson:  Sure.  It certainly has, rather surprisingly in a way, been of great interest for women with endometriosis struggling with a fertility problem.  Now, interestingly enough, that was not the original intention because the acronym of the trial, which was the flush trial stemming from flushing with Lipiodol for unexplained sub-fertility by hysterosonography, really reflects the fact that we were looking to see whether there was a benefit of Lipiodol in women or, indeed, couples, primarily with unexplained fertility delay.   

Now, I should perhaps just go back a step and tell you what Lipiodol actually is.  It is really an old oil-soluble contrast medium that used to be used formerly for the diagnostic test of a woman’s fallopian tubes.  When I say old, what I mean is that it used to be used in New Zealand perhaps twenty years ago, common with many developed countries at that stage, but it was superseded when the new water-soluble media came along.  Now, it is actually an iodized poppy seed oil and we were alerted to it by some reports in the literature that suggested that the pregnancy rate after such a diagnostic procedure was actually increased for some couples.  So we actually designed a trial to look at this in a more rigorous fashion. 

Deborah Bush QSM:  Was there anything else that you knew of that prompted and initiated you to get going with the trial? 

Dr Neil Johnson:  Well, I think it has long been speculated, and I suppose it is something of an old clinician’s tale, the concept that flushing a woman’s fallopian tubes in some way enhances her fertility, perhaps by flushing out some debris from the fallopian tubes that is not actually blocking them, but which in some way is hindering pregnancy.  So that was really the background to it all and then we decided to set the trial up. 

Deborah Bush QSM:  It is most interesting.  When did that happen? 

Dr Neil Johnson:  We were really looking at this about four years ago and the trial itself did commenced about four years ago now and we completed follow-up really just within the last couple months.  We recruited participants for the study for roundabout three years, almost three years, and very kindly 158 women volunteered to be in the study.  We were actually looking for 150 and I think you indicated, Deborah, that there was a bit of media interest in this and that actually helped us with the study, particularly as we seemed to be getting good results.  So that was a really good effect on recruitment to the study and it has actually really helped the research. 

Deborah Bush QSM:  Well, what happened on television, of course, is that you came across with such excitement at the initial findings, Neil, that I think it probably prompted many women from the country to see if they could climb on board and be part of, not just part of the study, but also have some positive outcomes for their own achieving a pregnancy. 

Dr Neil Johnson:  I think that is the crux of it, that really the results, particularly for women with endometriosis, which I can tell you about, were somewhat surprising and it was really great to get such a good result from the study.  We were really anticipating being able to pool the results for the couples with purely unexplained infertility with the results for the women who had the kind of endometriosis, which has not actually blocked the fallopian tubes.   

But what we found was that in those couples where the women did have endometriosis that the natural pregnancy rates, in other words, the chance of a pregnancy without any treatment, was quite a bit lower than it was for the couples with purely unexplained infertility.   

But the very good news was that the treatment effect in those women with this form of endometriosis was quite dramatic and it enhanced the pregnancy rate approximately four-and-a-half fold over the six-month follow-up phase of the study.  What it actually meant was that, of the women with endometriosis, approximately half of them did actually get pregnant within that six-month follow-up phase and we thought that was really very exciting given that the actual duration of infertility prior to going on to the study was five years.  So we thought that was excellent. 

Deborah Bush QSM:  Absolutely, Neil, and the outcome has meant several things for you.  Could you go on and tell us about that? 

Dr Neil Johnson:  Meaning what, Deborah?  

Deborah Bush QSM:  The outcome, I know that you presented the findings when you were recently in Australia and I would really like to hear about that, Neil. 

Dr Neil Johnson:  Okay, well, I have presented at two fairly big medical meetings so far.  First of all, the RANZCOG meeting, the Royal Australian-New Zealand College of Obstetricians and Gynaecologists meeting, which we held in Auckland last September, and it seemed to go down pretty well there.  Then, rather surprisingly, in presenting at the Fertility Society for Australia in Perth in November 2003, the research got the award for the best paper, which the whole research team were absolutely thrilled about.  The prize for the research is that they have kindly invited me to go and represent the Fertility Society for Australia at the British Fertility Society in Cheltenham, where I will be presenting the work again in April this year.  So, yes, I will be doing a bit of travelling with this, as well as all the other more obvious really good outcomes from this study. 

Deborah Bush QSM:  What was the basis?  Why does it work? 

Dr Neil Johnson:  That is a very interesting question, because I do not really buy the argument that Lipiodol is just a more effective flusher of this kind of debris from fallopian tubes that is maybe hindering pregnancy.  It is probably more the effect, rather than the flush-through of the fallopian tubes.  It might actually be what happens once it does get through the fallopian tubes, perhaps an effect on the intra-peritoneal environment, and there is some evidence to back this up, that it perhaps does something to enhance the immunology of the pelvic cavity, which perhaps makes the whole environment more conducive to pregnancy, either by a positive effect on the quality of eggs, which are produced, or the interaction between sperm and eggs.   

The other theory, and one that we are now moving toward, and I must say that this is still a hypothesis although we have got some growing data to support it, is that it might simply be an endometrial effect; so, in other words, an effect on the inner cavity of the uterus that possibly improves the chance of an embryo implanting.  We need to work that out still further. 

Deborah Bush QSM:  So you are still at the stages of understanding quite why. 

Dr Neil Johnson:  Very much so. 

Deborah Bush QSM:  But the outcomes certainly have positive results. 

Dr Neil Johnson:  Yes, indeed. 

Deborah Bush QSM:  Well, I would like to take this opportunity of congratulating you on the award and I am sure that when you meet up in the UK later on, in fact it is not too far in the future, in April, that it will be met with the same kind of enthusiasm and buzz that it received here in New Zealand, so congratulations, Neil.  We look forward to the development of the Lipiodol and flushing in relation to the treatment of endometriosis-related infertility.  We wait on outcomes and I am sure there will be further follow-up and investigations and evaluations in the not-too-distant future. 

Dr Neil Johnson:  Very much so.  Thank you very much, Deborah. 

Deborah Bush QSM:  Thank you.

Feedback/Questions:

Question: 

I have read about LIPIODOL flushing about 6 month ago. Since then I have only one question to ask: When and how I can receive this treatment? It seems very promissing for women with my type of infertility. I have minimal endometriosis and 10 years of infertility. Interestingly I have heard about this effect many years ago in Russia where this solution for an x_ray of the fallopian tubes was used for many years.

Olga Samoilova

Answer:

The pleasantly surprising effectiveness of Lipiodol for women with endometriosis but with normal fallopian tubes is a very new finding (although the concept itself is not new). So far I've only presented it at the RANZCOG Meeting and Fertility Society of Australia Meeting last year and I've been invited to present it at the British Fertility Society Meeting. Therefore, as Lipiodol HSGs were no longer widely used diagnostically from about 1980 onwards, there aren't many centres offering it. At the moment two places offer it: our centre that can be accessed through my University Specialists Clinic in Auckland, e-mail unispec@auckland.ac.nz, tel +64 9 6304832 (and we have had patients from as far afield as Europe & Burkina Faso coming over to New Zealand for Lipiodol procedures!); the other clinician with expertise in Lipiodol therapeutic procedures is Andrew Watson, O&G Consultant in Tameside, Lancashire, United Kingdom. There are some potential pitfalls to avoid so it pays to have a clinician with particular expertise in this area, rather than someone carrying out the occasional procedure.

Neil Johnson, MD