Frequently Asked Questions

The INVOCELL Intravaginal Culture System (also referred to as the INVOCELL Culture System or the Vaginal Incubation System) consists of the INVOCELL Culture Device and the INVOCELL Retention Device.1

The INVOCELL Culture Device uses a woman’s body as an incubator to support fertilization and embryo development. The patient undergoes a mild ovarian stimulation and monitoring cycle. Once the eggs are retrieved and sperm is collected, they are placed into the INVOCELL Culture Device. The Culture device is then placed within the Retention device, which is then immediately positioned in the vagina to allow for fertilization and incubation to take place. Upon completion of the incubation period, the device is removed, allowing for the transfer or storage of embryos. For details regarding the INVOCELL procedure, please refer to the Instructions for Use.

In order to receive FDA clearance, 2 clinical studies were conducted. These studies provided data to support FDA clearance.

In 2015, the INVOCELL IVC System received clearance from the US Food and Drug Administration as the first IVC System.

INVOCELL is the first and only FDA-cleared IVC System.

A semen sample with normal semen parameters is required.

Yes.

Yes, the INVOCELL IVC System may be an option for same-sex couples, similar to other ART.

The INVOCELL IVC System is a novel treatment option for individuals considering ART.

Similar to traditional IVF, eggs are retrieved in preparation for an INVOCELL procedure while, for IUI, the eggs remain within the body.

Please see Clinic Locations for a list of fertility clinics in the United States that currently offer the INVOCELL IVC System. Ferring is
in active conversations with additional healthcare providers and fertility clinics to increase accessibility of INVOCELL. We expect the
number of fertility clinics offering the INVOCELL IVC System to expand by leveraging Ferring’s resources, knowledge, and scale.

While a primary care physician or gynecologist may be able to begin the process of evaluation, and even prescribe basic treatments,
patients will need to see a fertility specialist for beyond basic testing and treatment.

Ferring is committed to helping people build families and live better lives. As a leader in reproductive medicine and women’s health,
the INVOCELL IVC System aligns with our mission of expanding fertility treatment options to couples navigating infertility.

REFERENCE 1. INVOCELL Intravaginal Culture System [instructions for use], Medfords, MA: INVO Bioscience.

SELECT IMPORTANT SAFETY INFORMATION

  • Culture and Retention Devices should not be used in patients with the inability to tolerate placement or wearing of a device within the vaginal cavity.
  • Culture and Retention Devices are single use only. Do not use if product or package appears damaged.
  • Do not use Culture Device in patients with hypersensitivity to medical grade silicone or polystyrene or in patients with a severe case of vaginitis or with a history of toxic shock syndrome. Evaluate patients for any recent pelvic surgery to assure it will not affect intravaginal culture procedure.
  • Proper handling is extremely important to safe and effective use of Culture Device. Do not begin clinical use of INVOCELL Intravaginal Culture System without establishing competency by reading and practicing Instructions for Use.
  • It is recommended that INVOCELL Intravaginal Culture System be utilized with a mild ovarian stimulation protocol. The recommended upper limit on number of oocytes or ICSI fertilized embryos to be placed in Culture Device is seven.
  • Verify Culture Device is correctly locked before placement in vaginal cavity.
  • Patients should avoid any activity that may alter temperature of vaginal cavity and should avoid manipulation and removal of Culture and Retention Devices while in place.

Please see the full INVOCELL Intravaginal Culture System Instructions for Use for more detailed information.

INDICATIONS FOR USE

INVOCELL® Intravaginal Culture System consists of the INVOCELL Culture Device and the INVOCELL Retention Device. The Culture Device is indicated for use in preparing, holding, and transferring human gametes or embryos during In Vitro Fertilization/Intravaginal Culture (IVF/IVC) and Intra-Cytoplasmic Sperm Injection Fertilization/ Intravaginal Culture (ICSI/IVC) procedures. The Retention Device is indicated for use during the incubation period to aid in retention of the Culture Device in the vaginal cavity. The Culture and Retention Devices are not indicated for incubation periods exceeding 72 hours.

SELECT IMPORTANT SAFETY INFORMATION

  • Culture and Retention Devices should not be used in patients with the inability to tolerate placement or wearing of a device within the vaginal cavity.
  • Culture and Retention Devices are single use only. Do not use if product or package appears damaged.
Please see Indication and Select Important Safety Information