Crowdfunded Fertility Clinic Lets Women Grow Embryos in Plastic Vaginal Capsules

When Sara Hesse was tagged on Facebook last May for a crowdfunding campaign, she hesitated. The project was asking for $4000 up front, to help build a budget fertility clinic in Calgary, which would offer her one round of a sort of do-it-yourself in vitro fertilization treatment in return for her support.

She and her husband, Chad, were already on a waiting list at the Regional Fertility Program, the only other clinic in town, which charges around $16,000 for a round of conventional IVF. (Both prices include drug costs.) The couple, in their early thirties, discussed it for about a week. But just one day after the campaign formally opened, they were in. "First and foremost," said Sara in an interview, "it was cost."

The Hesses were number 27 on a list of 100 "founder" patients. The first 19 patients signed up on the very first day, and all 100 were on board within 65 days.

The clinic, called Effortless IVF, opened its doors to these initial 100 patients on Feb 14. It plans to open to more patients—some 60 more are now in line—in early March, said Jason Broome, the clinic's co-founder and director.

Conventional IVF and this newer variant—called intravaginal culture, or IVC—both involve stimulating the ovaries to produce extra eggs, removing the eggs surgically, putting sperm and eggs together artificially and placing nicely-developed embryos into the uterus.

But there are some key differences. The most obvious is where fertilization and early embryo development take place. In classic IVF, that happens outside the body. In IVC, all of that takes place inside a woman's body—specifically, inside a little plastic capsule tucked inside her vagina.

The 4cm-by-3cm capsule, called an INVOcell, is about the size and shape of an old photographic film canister. Made of polystyrene (just like petri dishes), it is gas-permeable, so appropriate levels of carbon dioxide and oxygen can be maintained inside it by the woman's own body. She also keeps the temperature even and filters out toxins with her liver and kidneys. These are complex and expensive operations when handled by a mechanical incubator, but "effortless" when managed in-house, according to Broome.

Under this new protocol, eggs will spend only five minutes co-incubating with sperm outside the body, before being placed into the capsule, with a scrum of sperm hanging onto their outer shells. The INVOcell capsule will remain inside the woman's body, held in place by a diaphragm-like retention device, for five days, during which time winning sperm will declare themselves and embryonic development will kick off.

On day five, the capsule is removed, the best one or two embryos are selected for transfer into the uterus, and any remaining good embryos are frozen for future use.

The INVOcell, owned by INVO Bioscience in Medford Massachusetts, was approved by Health Canada in 2014 and by the FDA a year later.

 Not having to pay for 24-hour incubators and all the sensors needed to make sure they are functioning properly accounts for a part of the budget price—which, for post-founder patients, is $6500, plus an administrative fee. But other details about how the clinic will work are different too.

Effortless IVF patients, for instance, will not be intensely monitored as they take drugs to promote egg production. Normally, women go for blood tests and ultrasounds every few days, but in this new model, doctors prescribe very low doses of the drugs, based on body weight and a measure of egg volume, and then they schedule a single ultrasound on day 10.

Using a lower dose of fertility drugs not only lowers the actual drug costs; it also reduces the risk of complications, and therefore the need for extensive monitoring, said Broome.

Other protocols make it possible for the clinic to close on weekends—which also saves money. For instance, all day 10 ultrasounds will happen on a Monday, said Broome, and based on how the eggs are developing on that day, the egg retrieval will be scheduled for either Wednesday, Thursday or Friday that same week. The INVOcell will remain in place for five days after that, meaning that embryos are transferred to the uterus on either a Monday, a Tuesday or a Wednesday the following week.

Read More: An Egg Freezing 'Pop-Up Store' Appears in London

The clinic places a premium on accessible communications, with payments, appointment bookings, reminders and medical records available online. Broome called it "digital healthcare"—something not common in Canadian fertility medicine.

For all the differences, though, ultimate success rates appear to be about the same. Broome, along with Kevin Doody and Kathleen Doody, who are fertility doctors at the Center for Assisted Reproduction in Bedford, Texas, randomly assigned 40 women to receive either IVF or IVC, and placed up to 10 eggs into either an INVOcell or an incubator.

Rates of fertilization, pregnancy and live birth were all similar between the groups, they reported last April in the Journal of Assisted Reproduction and Genetics, although classic IVF produced more high-quality embryos. There were 11 successful pregnancies in the IVC group and 12 in the IVF group.

The process won't work for everyone. Couples who need intracytoplasmic sperm injection (ICSI) for problem sperm, for instance, won't benefit. Women at risk of overstimulating, such as those with polycystic ovaries, may not want to do their cycles without careful monitoring. Obese women may not fit the bill either. And anyone looking to do genetic testing on their embryos won't get that through this budget clinic.

The Calgary clinic—which is a walk-in, with no referral necessary—is the first stand-alone IVC clinic in the world, said Broome. He has plans to bring something similar to Montreal, Toronto and Vancouver.

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