The trial will measure InvoCell’s effectiveness in achieving fertilization, implantation, embryo development, clinical pregnancy and live birth after 5 days of continuous vaginal incubation, according to the Sarasota, Fla.-based company. The device is currently cleared for 3-day use.
The trial will also assess the efficacy, comfort and retention of the InvoCell with the retention device, and seek to demonstrate superiority following 5-day vaginal incubation as compared to the current 3-day vaginal incubation indication.
The pivotal trial is a single arm, multicenter, open-label trial at three U.S. clinical centers, with each center enrolling 60 patients between the ages of 18 and 37 years. The providers at each center will conduct the processes of ovarian stimulation, egg retrieval and embryo transfer per the standard protocols for their centers. Patient recruitment at each site has begun.
Currently in the United States, 62% of fresh embryo transfers are performed on day 5 and 30% on day 3, according to a 2016 Centers for Disease Control assisted reproductive technology report.
“Expansion of our label to 5-day continuous vaginal incubation is a key objective as we look to enhance the InvoCell procedure beyond its currently approved 3-day use and align with the current standards within the fertility industry,” said Invo Bioscience CEO Steve Shum in a news release. “Now that we have begun recruitment, we look forward to the clinical sites commencing enrollment shortly.”
InvoCell won FDA de novo approval in November 2015 and was launched in the U.S. in April 2016. It is distributed throughout the U.S. under an $8 million agreement with Ferring Pharmaceuticals, which the companies entered in January 2019.
Ferring is providing Menopur (menotropins for injection) at no cost to clinical participants. Invo Bioscience will receive a $3 million milestone payment from Ferring if the FDA grants the 5-day clearance.
“Conducting the pivotal clinical trial is a critical step in continuing to expand our commercialization of the InvoCell system, and, most importantly, realizing our mission of advancing the treatment of infertility,” said Invo Bioscience VP Lori Kahler.