INVOCELL is the first intravaginal culture system granted FDA approval in the United States. This novel device and procedure provides a more natural, simple, effective, and economical fertility treatment. The optimum candidate for this new device is a good prognosis patient with age less than 37 with normal sperm and reproductive function.
The INVOcell device provides patients with the opportunity to have an additional option other than the long standing and standard treatments of intrauterine insemination (IUI), which has low success rates of approximately 10% pregnancy per cycle, and in vitro fertilization (IVF) which requires fertilization and embryo development in the laboratory with increased cost. In fact, INVOcell can be offered to patients at about half the cost of a conventional IVF cycle.
During an INVOcell procedure, the patient undergoes a mild ovarian stimulation cycle with the goal to retrieve 5-9 mature oocytes. Once the eggs are retrieved and sperm is collected, they are placed into the INVOcell device, which is immediately placed in the upper vagina.
The INVOcell device is used for the incubation of eggs and sperm during fertilization and early embryo development. Unlike conventional infertility treatments such as IVF where the eggs and sperm develop into embryos in a laboratory incubator, the INVOcell utilizes the women’s vagina as an incubator to promote in vivo conception.
The INVOcell device is positioned in the upper vaginal cavity for incubation along with a retention device which is similar to a diaphragm. Natural fertilization and early development of the embryos take place in the vagina. After incubation for 5 days to allow for blastocyst formation, the device is removed, and the embryo is transferred into the uterus.
In phase IV clinical studies, the INVOcell device and procedure of vaginal incubation was equivalent to traditional IVF incubation when comparing the quality of resulting embryos, pregnancies and live birth rates, which was the primary endpoint of the trial. The clinical trials provided to the FDA included a total of 450 INVO cycles with 132 live births performed in 4 reproductive centers.
These cycles were monitored from the first day of the ovarian mild stimulation to the live births. There were 330 cycles performed with insemination taking place in the INVOcell device with embryo transfer after 3 days of vaginal incubation. There were 120 cycles performed with the insemination by ICSI followed by 3 days vaginal incubation.
The results of these trials are as follows: clinical pregnancy rate 32.4%, multiple pregnancy rate 15.1%, and live birth rate 23.8%. These results are comparable to traditional IVF. Additionally, over 3,000 cases have been performed across the globe with similar pregnancy rates. More recently, the INVOcell procedure has been modified to allow the device to remain in the vagina for 5 days to allow for blastocyst formation with the preferred transfer of one blastocyst into the uterus to minimize multiple births.
There are many advantages to the INVOcell device and procedure, including:
- offering an alternative affordable treatment to those who cannot afford traditional IVF
- preference for a more natural, cultural, or religious appropriate choice
- uses vaginal cavity as a more stable environment than an incubator for temperature, pH, and gas concentration during fertilization and early development of embryos
- allows patients to incubate their own gametes, providing a psychological benefit while reducing the risk of wrong embryo transfer
- uses mild stimulation protocols and decreases the number of oocytes required, which may reduce the risk of severe ovarian hyperstimulation
- reduces the risk of multiple births
- reduces the need for embryo cryopreservation and storage
- alternative for same-sex couples who both want to participate in the reproductive experience