INVOcell: Not nearly IVF

January 28, 2011Carole 7 Comments »

There should be a limit to what women are expected to subject themselves to for pregnancy. In my opinion, INVOcell is one thing too much. INVOcell is a device that is marketed as a low cost alternative to IVF even though  it appears to have none of the advantages and several disadvantages in efficacy and safety compared to lab IVF. INVOBioscience, a  Massachusetts company,  has received approval to market this device in the EU. A new 40 patient clinical trial has been started in Brazil. The FDA wants a 75 patient study before they will consider approving it in the US.

What is INVOcell? INVOcell is a medical device that turns your vagina into an incubator.  Your doctor performs an egg retrieval, then combines eggs and sperm in a small plastic device which then is placed in your vagina for three days. The device is held in place by a diaphragm. You can look at a photo of this device here.  Essentially, the vaginal environment is expected to supply the right temperature, pH and low oxygen tension for fertilization and embryo development. After three days, the device is removed and placed in a warming block to allow the cellular material to settle, making it easier to find embryos inside the device. Apparently, embryos were difficult to find in prototypes of this device because after the natural loss of the cumulus cells, the embryos were difficult to see. After three days, the device is removed and embryos can be recovered and transferred to the uterus.

There are two problems with uninterrupted and unsupervised culture of embryos.

1. Culture medium deterioration. The sperm cells and cumulus cells die over the course of three days and expose the developing embryo to culture media whose quality is deteriorating. The manufacturers claim that they use such small sperm numbers (30,000 sperm) that this is not a problem.  Although unusual, it is possible to find bacterial contamination in a culture dish the day after insemination, which is generally traceable to a sperm infection. Undetected and untreated in the INVOcell, an infection would likely destroy the embryos by acidifying the pH of the culture medium. In regular IVF, the culture medium is changed the morning after insemination and on day 3 of culture.

2. Abnormal embryos are not identified before transfer because there is no fertilization check step. In an IVF lab, around 16 hours after insemination, the embryologist has a four hour time period to look for two transient structures called pronuclei in each egg. The presence of two pronuclei  verifies that the embryo is normally fertilized. Excess sperm can enter an egg, causing a condition called polyspermy. Again, the manufacturer claims that the risk of polyspermy is reduced in their system because they use few sperm. Actually, the quantity of sperm for INVOcell is very similar to what is used in the IVF lab and cases of polyspermy do occur in regular IVF.

Furthermore, polyspermy is commonly caused, not only by excess sperm numbers, but also by a defect in the egg which prevents the normal barrier response of the egg to further penetration and fertilization after entry of the first sperm. The technical solution for this egg condition is ICSI, so that only one sperm enters the egg. Interestingly, the company says that you can put ICSI’d eggs into the device too. I think after I have paid for ovarian stimulation, egg retrieval and sperm injection, I think I can spring for a couple of days in a real IVF incubator, instead of this inferior solution. A chromosomal abnormality in the egg called polygyny may also cause abnormal fertilization because the egg retains an extra set of maternal chormosomes. Polygyny is also detectable at fertilization check when an abnormal number of pronuclei are visible inside the egg.

Abnormal embryos resulting from either polyspermy or polygyny would not be detectable in the INVOcell. This is a problem because transferring abnormal embryos can not only lead to failed implantation (most of the time) but also more infrequently to gestational trophoblastic disease.  Some forms of gestational trophoblastic disease can cause conditions such as molar pregnancy or a type of cancer called choriocarcinoma. In order to avoid these risks to a healthy pregnancy, the  fertilization check step is very important. IVF performed in a lab allows verification of normal fertilization before it is too late. By day 3, both abnormal and normal embryos cleave and develop into embryos, making it impossible to distinguish chromosomal abnormalities without genetic testing of the embryo.

The manufacturer claims INVOcell is really low cost, but is it? You still have to undergo an egg retrieval like IVF and for best results, an ovarian stimulation, like IVF. Although advertised as a cheap alternative to IVF, the costs associated with ovarian stimulation and egg retrieval are two-thirds of the cost of IVF, not the lab procedure, certainly making it less of a bargain. When you consider that the manufacturer boasts only a 19.6% pregnancy rate, about  half of what the average US IVF clinic is able to deliver and not even half of what the best IVF clinics delivers in terms of pregnancy rates, you may reevaluate this “bargain”. For more information, you can download a pdf of a published paper by the manufacturer, “A clinical presentation on INVOcell”, from the company website.

What about extra embryos? In a non-lab environment, will patients have the option to cryopreserve extra embryos? Cropreservation of embryos is one way to transfer fewer embryos in the fresh cycle and reduce the incidence of multiple gestation pregnancy which carries increased risks to the health of both the mother and baby. Because cryopreservation of embryos allows patients to have future frozen embryo transfer procedures using their stored embryos, patients are saved the costs incurred for a new egg stimulation cycle, egg retrieval and embryo culture. Therefore, cryopreservation of excess embryos extends the value of the original ovarian stimulation and egg retrieval.

Because this device allows you to turn your vagina into an incubator, according to the manufacturer, the device is  “promoting more involvement by the woman”.  Excuse me? “More involvement by the women”? Women don’t have to use their vaginas as incubators to become “more involved” with reproduction!  I think all women who are trying to become pregnant and then do get pregnant are plenty “involved” with their reproductive project! It reminds me about the joke about the chicken and the pig and who is involved and who is committed to your breakfast. Women are not only involved but seriously committed to making that pregnancy happen if they want children. The notion that this device allows women to become more “involved” is, frankly, insulting.

I am all for innovation and low cost but in my opinion, this device (which shows up in the news about every two years) just doesn’t cut it. You can listen to this YouTube video where the CEO of the company discusses how this device is useful for IVF clinics and OB practices who want to increase their revenue stream. I suppose that when this device fails, the IVF lab is nicely positioned to offer you real IVF with a better chance of pregnancy.

© 2011, Carole. All rights reserved.

7 Responses to this entry

  • Boris Says:

    Also some facts from the 2008 CDC data of all reporting sites in the USA… This is the data that is raw and not ‘framed’ for advertising by IVF clinics.

    Traditional IVF yielded a clinical pregnancy rate of 34%
    ICSI IVF yielded a clinical pregnancy rate of 33%

    % of IVF using ICSI – 65%
    % of IVF NOT using ICSI – %34

    53% of ICSI cycles were done without any (not even mild) male factor.

    IVF clinical pregnancy rates peak at 2 embryos transferred (44%) and drop to 35% with 3 embryos and even less when more than 3 were transferred. Less is more in this case.

    http://www.cdc.gov/art/ART2008/PDF/ART_2008_Full.pdf

  • INVOcell Post Strikes a Nerve | Fertility Lab Insider Says:

    […] PostsINVOcell Post Strikes a NerveSART oversight of ART in the USIs IVF dangerous to your health?INVOcell: Not nearly IVFWhat is aneuploidy?PagesAbout MeBlogBlog RollContact MeCurriculum VitaeGlossaryHomeLinks to more […]

  • J. Bird Says:

    I came here looking for information on invocell and found this totally bias article slamming the procedure. Having read some of the latest information from the company, I know that many of the negative statements are false and seem to clearly be written by someone that is trying to protect their own personal financial interests. Shame on you. So many negative assumptions and words have been written in this article in an obvious attempt to keep the price of bringing a child to the childless high.

  • Carole Says:

    Dear J. Bird,
    I am sorry you feel this way but you are sadly mistaken. I have absolutely no financial interest in ANY IVF product or any IVF program. I am writing this non-commercial blog for one reason and one reason only, because I have seen fertility patients taken advantage of and sold all kinds of ineffective and sometimes dangerous products to make a buck. Selling overpriced ineffective services to infertility patients makes me sick and angry and disgraces the hard work of the dedicated IVF professionals out there. I have a problem with INVOcell because it lacks many of the safety features built into regular IVF procedures. I have read the company’s marketing web content too and it is not persuasive when you dig up the few published papers. It is not approved by the FDA as a safe or effective treatment because there is insufficient scientific data to insure that it is safe and effective. Cheap is great but not if it doesn’t work or makes you sick. INVOcell has not been scientifically proven. It may be- SOMEDAY- but it is not there yet. All the wishful thinking in the world won’t change that. Good Luck.

  • sunil Says:

    DEAR CAROLE ,
    AGREED IF WHAT YOU ARE SAYING.I M SURE WHATEVER DAT COMPNAY MAY HAVE PRODUCED TO BACK THEIR DATA,HOW ARE YOU SURE THAT THIS IS INSFFECTIVE.IS IT THAT US F D A IS FINAL AUTORITY IN THE WORLD.LET CLINIIAN ALL OVER THE WORLD THOSE WHO HAVE EXPERIENCED COMMENT ON THIS. WE WOULD LIKE TO KNOW MORE ON THIS.

  • Fertility Lab Insider - Lessons learned from over fifteen years of working inside fertility labs. » Blog Archive » INVOcell- Analysis of Risk vs Benefit Says:

    […] Invocell- not nearly IVF […]

  • peter Says:

    Fda has approved this device. The savings will be passed-along to consumer.
    I believe it will be first choice for most once it’s available.

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