October 21, 2018

New Options in IVF

How INVOcell is changing infertility treatment

 

Over the past 40 years, in-vitro fertilization has become more and more reliable through genetic testing, intracytoplasmic sperm injection, continuous video microscopy of developing embryos, and many other technologies.

But a new technique hopes to achieve successful pregnancies without those techniques and tests, without an incubator and without many of the steps and drugs that make IVF so expensive.

INVOcell™ is an infertility treatment that gained FDA approval in 2015. The small plastic device allows for fertilization to occur within the vagina. Since the vagina is the correct temperature and pH to keep both sperm and eggs alive, the technique doesn’t need a temperature-controlled lab or a lot of specialty equipment.

Gerry Celia, PhD

“INVOcell was originally geared to the extreme rural markets like those found in many African and South American countries,” says Gerry Celia, PhD, director of the IVF Laboratory at EVMS Jones Institute for Reproductive Medicine. “These countries don’t have the infrastructure to support a lab.”

The procedure also requires fewer lab technicians and experts, which can be hard to attract to a rural town, and costs less, helping people who may not be able to afford IVF. Though the process is similar to IVF, it involves fewer tests and much less equipment and was not meant to replace IVF procedures in places where patients have access to modern resources. 

The INVOcell Process
The INVOcell process begins with mild ovarian stimulation. However, since only about 7 embryos can fit into the device, the patient uses fewer stimulation drugs than with traditional IVF. This is the first place where couples typically save money. By using fewer drugs, they can potentially save thousands of dollars.

Next, the eggs are retrieved and sperm collected. A physician or lab technician inserts them into the INVOcell device, which a physician places in the woman’s vagina. The device is held against the cervix with a diaphragm device for three to five days, allowing fertilization and early embryo development to occur. This is another time where couples may save money. They won’t need to pay lab costs to store and monitor the sperm, eggs and early-stage embryos.

“Incubation of the INVOcell in the vagina mimics what we do in an incubator,” says Dr. Celia.

When the couple returns, the best embryos are selected for transfer. Just like IVF, the couple then needs to cross their fingers and hope an embryo implants.

Early results show that INVOcell achieves similar rate of pregnancy as traditional IVF treatment in women who have a high chance of success. This includes women under the age of 38 with normal ovarian reserve, a body mass index below 36 and a partner or donor with good sperm parameters.

Robin Poe-Ziegler, MD, FACOG

“The INVOcell cycle is dramatically less expensive than an IVF cycle, but our pregnancy rates are very similar,” says Robin Poe-Zeigler, MD, FACOG, Medical Director of the New Hope Center for Reproductive Medicine. Her practice began offering INVOcell in June 2017. “It’s really opened an avenue of conception for patients who previously were not able to afford an IVF cycle.” 

The Cost of Lower Costs
Though INVOcell works as well as IVF for that specific population, it’s currently unclear how well it works for other women who may face more challenges in achieving pregnancy. Because INVOcell leaves out so many steps of IVF, physicians could miss out on important diagnostic information.

Through traditional IVF, the eggs and sperm undergo a fertilization check the day after they are combined. This fertilization check is not typically used with INVOcell, as it could put the embryos at risk. If the device has no embryos in it at the end of three or five days, it’s not possible to know whether fertilization failed or embryo development failed. 

INVOcell also takes away the ability to monitor embryo development over a five-day incubation period. 

“In a modern IVF laboratory, we can see the embryo develop in real time through continuous video microscopy,” says Dr. Celia. “Watching that development tells us a lot about how that embryo is growing and whether it is normal or abnormal. An embryo that fertilizes abnormally, and therefore has chromosomal abnormalities, can have normal morphology on day three or day five.”

The FDA approved only a three-day incubation period for INVOcell, though five days of incubation is preferred. Five-day incubation gives embryologists and physicians time to see how healthy the embryo is. The change to a five-day incubation periods around 2008 led to a rise in success rates of IVF.

“Embryos can develop through day three just by being fertilized,” says Celia. “After three days, they can fail due to the genetics contributed by the egg or sperm. We follow them through day five and six of development, which allows a much greater ability to select a good embryo from a bad embryo.”

INVOcell also doesn’t include genetic testing. For many couples, this may not be an issue. But for families with genetic conditions like cystic fibrosis or Tay-Sachs disease, or advanced maternal age where diseases such as Down syndrome become a concern, this testing can be incredibly important.

While taking away these tests does make INVOcell much cheaper, Dr. Celia fears it could also put some couples at a higher risk of failure than IVF, adding costs and prolonging infertility treatment. Compared to other low-cost options that include monitoring embryo development, INVOcell leaves clinicians in the dark when a cycle fails. He also warns it could be a couple of years before the data is available on how effective the procedure is in many different populations of women.

In the end, Dr. Celia also says INVOcell could end up raising the price of IVF for women who choose that procedure if they are anything less than ideal candidates.

“It is important to realize that there is no difference in operating costs or personnel costs when INVOcell is used in a modern IVF clinic. The potential savings come from using minimal stimulation protocols, which are already offered at The EVMS Jones Institute and most other IVF centers in the United States,” says Dr. Celia. “When these options are available at a similar cost to the patient, but with the advantage of modern IVF technology, there may not be a benefit to using INVOcell.”

A Hybrid Solution
Many practices allow patients to add back in some testing or other procedures while still using the INVOcell device for incubation. While these changes in protocol may raise the price, they may also improve chances of success for certain patient populations.

“We’ve used INVOcell with patients in their 40s, in patients using intracytoplasmic sperm injection because of male factor infertility; we’ve used it for all different types of patients,” says Dr. Poe-Zeigler.

The first couple from the New Hope Center to have a baby using INVOcell was a lesbian couple in a co-IVF cycle. The device allowed both partners to be more involved with the pregnancy. One partner provided the eggs and used the INVOcell device while the other partner had the embryos transferred into her uterus. Both partners got to carry the baby, at least for a short time.

Like many practices, the New Hope Center will also perform genetic testing on embryos before implantation and will freeze any excess embryos for possible IVF cycles in the future. Though these services were not originally intended to be part of the INVOcell process, they do allow patients more flexibility in their treatment.

Even with these extra tests, INVOcell remains cheaper than IVF. Many couples see it as an opportunity to complete two cycles for the price of one. Other couples enjoy the peace of mind of keeping their embryos with them throughout incubation instead of leaving them in a lab.

Though the final verdict on INVOcell may be years away, when more information on success rates is published, patients seem to have made their decision about this technology.

“It’s incredibly popular,” says Dr. Poe-Zeigler. “Couples can use reproductive technology at almost half the cost and still get the same success rates. At our practice, we now have more patients requesting INVOcell than IVF.”