Colorado protocol

Dear Professor Winston,
I am a 34 year old woman. My husband (age 42) and i have been trying to conceive for the last 5 years. Following numerous investigations it was found that my husband had a low sperm count, motility issues and anti sperm antibodies. I was diagnosed with polycystic ovaries. It was recommended to us that we proceed with ICSI. In our first round we had 3 good quality blastocysts. We had a fresh transfer of one blastocyst with oestrogen and progesterone support which ended at miscarriage at 6 weeks. The following FET (frozen embryo transfer) with same meds, ended in miscarriage at 6 and half weeks and the third did not implant. Each of these attempts was supported by diet, acupuncture and hypnotherapy. We embarked on our second round again with ICSI. Genetic testing was completed for both my husband and i with no issues and no immune issues found when i was tested prior to starting this second round. Again we produced 3 good quality blastocysts. However this time for the transfer we added to the progesterone and oestrogen with low dose aspirin, 5 days of antibiotics following transfer and a week long course of prednisolone. I believe this is known as the Colorado Protocol. I again fell pregnant however no heartbeat was detected at 8 weeks, this was devastating for us to experience another loss. We opted to wait for the natural miscarriage however when this did not occur we went ahead with an evacuation of uterus at 9 and half weeks, where the resulting tests found Trisomy 7 as the cause of the miscarriage. We are due to start with our next FET. Our doctor is recommending that we follow the same drug protocol but continue the prednisolone for the first trimester if successful. The reasoning around this was explained that as i am fit and healthy, with no other health issues that it may be helpful. Do you think it is ok to use the medications listed and in your experience are they helpful? Is there anything you could recommend that would help us? We have been told that we have been unlucky. Many thanks, C

Dear C,

I was sorry to hear of the trisomy 7, which is very distressing and a slightly unusual cause of miscarriage. It is a chromosomal abnormality which is most commonly seen after culture of cells from the placenta, or after chorion villus biopsy – the method sometimes used to detect an abnormal fetus antenatally at say around 10 – 14 weeks. I mention all this because it occurs to me that this could just be an artefact and not the actually cause of your miscarriage – no doubt all this has been explained to you. Whatever, it is very unlikely to occur again so unless you have an identifiable chromosomal problem yourself (which doesn’t appear to be the case) another pregnancy should be free of such a tragedy.

What I do not quite understand is why the prednisolone, aspirin or antibiotics? Can the clinic give you a clear rationale for this? I know of no advantage in an entirely healthy woman and there may be hidden disadvantages. It seems a bit like magic to me and I have to emphasise that in general, good medicine is evidence based. The fact is that each time you have an IVF cycle your chances of getting pregnant with a live birth is no more than around 25%; it is admittedly about 30 – 35% with a blastocyst transfer and a bit lower with a frozen blastocyst. So it is most probable that what you are telling me is simply due to chance – indeed, the most likely outcome you would experience is not being pregnant at this stage, though I accept you have been desperately unlucky to have miscarried twice. However, you at least have one likely diagnosis – a relatively uncommon cause for one of these miscarriages occurring almost certainly out of the blue. So I cannot help but think your best shot is to grit you teeth and continue with the treatment as it seems very likely to me yoiu will beat the basic odds. When I was running the clinic at Hammersmith, I found that the great majority of women who conceived during IVF, but failed to have a viable pregnancy in that cycle, were eventually entirely successful. In general, it is unquestionably better prognostically to have conceived than not to have got pregnant at all. By the way, it is hard to say this but if you are unfortunate enough to miscarry again, make sure every effort is made to establish the cause.

One last thing – and forgive me for this observation – but I think you have been indulging in a little bit of magic yourself. Harmless enough, but whilst it may make you feel better, I have not found clear evidence that hypnotherapy or acupuncture make any difference to success rates. And generally speaking, an average sensible balanced diet is that most humans need to have a normal chance of pregnancy.

Best wishes
Robert Winston