The INVO® Solution will revolutionize the treatment of infertility. The INVO Procedure is a new and effective fertility treatment option allowing fertilization and early embryo development to take place inside the woman’s body. The INVO Procedure is now the first Intravaginal Culture (IVC) or in vivo incubation assisted reproduction technique available.
During an INVO Procedure, the patient undergoes a natural or mild stimulation and monitoring cycle. Once the eggs are retrieved and sperm is collected, they are placed into the INVOcell device. The INVOcell® device is immediately placed in the vaginal cavity to naturally incubate the eggs and sperm and to allow fertilization and early embryo development to take place. After incubation, the device is removed allowing for the transfer of embryos.
In phase IV clinical studies, the INVO Procedure of vaginal incubation was equivalent to traditional In-Vitro Fertilization (IVF) incubation when comparing the quality of resulting embryos, pregnancies and live birth rates, the primary endpoint of the trial.
The clinical trials provided to the FDA included 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 birth of the babies which was the primary endpoint of the trials. 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%, Birth Rate 23.8%, and Multiple Birth Rate 17.8%. These results are comparable to traditional IVF.