INVOcell Post Strikes a Nerve

February 9, 2011Carole 6 Comments »

Apparently, “Boris” loves INVOcell and reads my blog. I got his irate feedback the other day on my previous post “INVOcell: Not nearly IVF” and he wanted me to respond to his comment. “Boris”  doesn’t identify himself or his interest in INVOcell but he does appear to have a personal stake in the success of this vagina incubator. Physician? Developer? Stock holder?

So I have published his entire unedited comment below and my response in italics.

Dear FLI Blogger (He doesn’t really mean it, I am not dear to him 🙂),

Let us use this forum to have a discussion on the conclusions you have drawn about the INVOcell procedure above. I will attempt to bridge the gap between your understanding and my own of the procedure. (I think he just called me an ignoramus.) Maybe we can find common ground through evidence and logic!  (I would say I have struck a nerve here! I will be alert  for evidence- maybe even clinical data.)

1) Culture Media Deterioration. – The culture media deterioration is not an issue for INVOcell and has not been through thousands of procedures (not only in the new device but in the prototype as well). This rare bacterial formation has not shown itself often enough to be reflective in the percentages of success of the procedure. (Sounds like a statement of opinion. Where’s the proof ? A peer reviewed published paper would be a nice reference here.)

2) Abnormal Embryos – While I do not disagree with what you have said regarding this I have realized a few very important omissions. Polyspermia is present less than 10% of the time in IVF and virtually NEVER leads to any type of pregnancy. The polyspermic embryo has very close to zero percent chance of implanting. Therefore getting rid of the embryo will happen naturally and does not need to be done through intermittent checking by embryologists. This checking of the embryos can actually be dangerous to the healthy embryos as it adds more variables for contamination to the atmosphere in which the embryos are developing (though I will say it is a small risk). (Again, sounds like an opinion. Where’s the peer reviewed published paper? You don’t address the real dangers of not checking for normal fertilization. If polyspermy happens in only 10% of the patients, we should ignore it? And where do molar pregnancies come from?- ah- polyspermy.  You don’t address other types of abnormal fertilization that are routinely caught with regular IVF. I suppose you can just disregard this risk because it is low. Oh, that’s right, this low risk is completely avoidable through visual checking with IVF but you’re not selling THAT).

3) Savings – The savings of INVO is not simply the lab procedure but the entire lab itself. An INVO lab needs very little overhead equipment and can be setup in full for about 10 to 30k USD. To setup an IVF lab is orders of magnitude more expensive. This includes not needing CO2 incubators, air filtration, a much larger laboratory therefore higher rent or price to purchase, embryologists will be needed for a fraction of the time and therefore their cost will be limited… as well as many other factors. An INVO lab is a feasible way of being able to offer an IVF like treatment with similar efficacy in a smaller physician or OBGYN office. These OBGYN INVO centers are not just theory they are up and running in places in Colombia and Peru and offering this IVF alternative for half the price of IVF. (All these advantages are advantages for the physicians who don’t want to own labs but want a share of the IVF market , not the patients. It’s like selling a Ford Fiesta to a patient and telling them, don’t worry, it may not have all the safety features of the top of the line vehicle, but geez, it costs so much less for Ford to make.  And since you state it is so cheap to offer,  I think you ought to be able to offer INVOCell  for far less than half the price of IVF, currently around $6000, half of $12,000.)

Incorrect Data – The data you have linked to on their website is from a PROTOTYPE device and done 20 years ago when IVF success levels were around the 20% number you reference. More current trials are being done and have been done and if you looked at the most current data from their website you will see they boast a much higher clinical preg rate than you reference. (http://www.invobioscience.com/index-9.html) This data is out for publication with RBMonline.com. As well a separate clinical study was recently finished in Peru with a pregnancy rate in the mid 30 percentile. All I could find was this article for backup which is not the completed study however without further adieu… (http://www.thestreet.com/story/10796003/invo-bioscience-announces-the-initial-results-and-the-first-invo-baby-in-peru.html)  (First, RBMOnline is not exactly Cell or Nature, but none-the-less they use peer reviewers which is a plus but “out for publication” apparently means it has been submitted but not published (it’s not on the RBMOnline website as a published paper as of today) so this data may not yet have passed the peer review process. The new data you mention on the INVOcell website (a source with a distinct conflict of interest) shows data from an unpublished study (this is called marketing) that enrolled 95 young (average age 35) patients, coincidently the best possible candidates for pregnancy –so not representative of many older patients that use IVF. Peru, really? One baby? Again, marketing. Proof of concept, perhaps, but not enough data to endorse it’s use for the average, not ideal, patient.)

Reimbursement – INVO could also allow for a procedure that will be cheap enough to possibly get reimbursement from insurance companies which would help not only the infertile population get the treatment needed but also drive MUCH more business to IVF labs and INVO labs using the procedure. (Again, GOOD for the doctors bottom line but not necessarily good for the patients. Now you are talking about an INVOlab? Will an INVOlab be subject to inspection like a regular IVF lab? IF it’s a real lab, you’ll have overhead and inspections. If you are a physician, you know how difficult it is to get insurance reimbursement for what are considered experimental protocols. Do you realize this is a patient advocacy blog?)

Thank you for the writeup and I hope you will respond with your comments, questions and concerns!

Thanks for your post idea, I was actually done talking about INVOcell. Sorry, but I am still not impressed with the INVOcell. The overwhelming message I hear from your comment is that it is GREAT for docs who want to do IVF on the CHEAP. Unfortunately, with the lack of real data, I am not convinced that most patients will find more benefit than risk from INVOcell. I would be happy to be proved wrong, but at this stage, there is not enough data to endorse this product. This product is still in the research development stage. Patients should only consider using this product if they are enrolled in a clinical trial as human subjects. As human research subjects, patients are afforded more protections–assuming they are enrolled in  a research protocol that has been approved by an independent institutional review board. Like the FDA, which has not approved this device for clinical use in the IVF, I am still waiting for proof of efficacy and safety which will take more than one company sponsored peer reviewed paper that by your own admission is 20 years old.


© 2011, Carole. All rights reserved.

6 Responses to this entry

  • sulfababy Says:

    Way to go, Carole! Excellent, informative responses.

  • Boris Says:

    Hi FLI,

    The main point I was trying to make is it could be a great procedure for people (not just doctors) who cannot afford multiple expensive procedures of IVF. Let’s say you are right and INVO is slightly inferior to IVF… even 25% less efficacious… wouldn’t you still rather be able to give 2 procedures to someone, each having a 30% chance of success, than 1 procedure of IVF at 40%?

    I think it is an exciting procedure and could set new standards for a “real” lab and could make reimbursement (for people like your readers) possible throughout the US and not just in a few states in the next few years.

    We’ll have to wait for some literature or to hear from the FDA but I simply thought for you to totally dismiss this procedure was premature and founded on old data.

    p.s…If there was molar pregnancies it wouldn’t have any noticeable impact on the pregnancy rates as molar pregnancies are 1 in about 2000. 🙂

    Thanks for the good argument blogger!!

    Truly, I do wish the best for this site/blog and wish there was more like it.

  • Carole Says:

    Hi Boris,
    I agree that we need more infertility treatment options that are both effective and affordable. Unfortunately, because there already exist plenty of home remedies, herbal remedies, adjunct therapies and other unproven remedies that are hawked to infertility patients, I think we need to hold all potential therapies to the highest standards of efficacy. Having worked in the private sector and seen firsthand the crass commercialism of healthcare, I tend to react badly to commercial trumpeting of new remedies before the facts are in. I enthusiastically endorse clinical trials that are iRB approved and diligent efforts to prove efficacy. I appreciate your enthusiasm for new products –although I would disagree about molar pregnancies. The patients we had who suffered molar pregnancies found the experience frightening and frustrating since they had to wait for a year before attempting to conceive again so for them, the low impact on overall pregnancy rate would probably not be a compelling argument to promote a product that was unable to detect abnormal embryos. However, I appreciate your endorsement of the site and also hope that more ART professionals will speak up for patients and demand more accountability from the ART healthcare industry.

  • Richard Says:

    My wife and i just did invocell with an egg donor feb 19, 2012, we had two good eggs on third day after carrying invocell there was one egg left. They implanted the egg on feb 22, 2012 we are praying for our One And only. Today feb 24, 2012′, going to enjoy the weekend and update you all Monday

  • ed Says:

    Carole,

    I can see how you are aprehensive about “other” types of solutions to IVF, but for something to become FDA approved it has to go through various trials and that is all that was being offerred here.

    Strange that you would poo poo something without a body of work to either prove or disprove the effectiveness.

    The goal is to help as many as possible by making this more affordable.

    You seem to browbeat the notion that this is only good for the doctors because it reduces their costs??

    WELL,,,,,THAT IS THE POINT. If you reduce the barriers to entry then you make it more affordable to the masses by opening up the number of offices that can perform the invocell procedure at a lower cost.

    Not sure why you bash this effort rather than embrace it. As you stated, this would more than likely help bring the overall cost down even further.

    It has been a few years since you posted this and Invo is currently doing trials here in the US nd the FDA is reviewing the device so hopefully they are much closer to bringing this product to market.

    Thanks

  • ed Says:

    Richard, any update?

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