INDICATIONS FOR USE
INVOCELL® Intravaginal Culture System contains the INVOCELL Culture Device and 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). The Retention Device is used during the incubation period to aid in holding the Culture Device in the vagina. The Culture and Retention Devices are not indicated for periods of use exceeding 72 hours.
SELECT IMPORTANT SAFETY INFORMATION
- Do not use the Culture or Retention devices if you are unable to tolerate having a device placed within your vagina.
- Do not use the Culture Device if you are sensitive to medical grade silicone or polystyrene or if you have a severe case of vaginitis or a history of toxic shock syndrome. Tell your doctor if you have had any recent pelvic surgery.
- Avoid any activity such as sexual intercourse, strenuous physical activity, swimming, bathing in a tub (a shower is permissible), use of a douche, sauna, or any other activity that may alter the temperature of the vaginal cavity and avoid handling or removing the Culture and Retention Devices while in place.
- Your doctor should explain to you what to do if the Culture and Retention Device should shift in the vagina or fall out. Call your doctor right away should this occur.
Your doctor will determine if this product is right for you and will provide you with more detailed information about the risks and benefits associated with using this device. Always follow your doctor’s instructions. Contact your doctor immediately if you have any questions or concerns before, during, or after treatment.
For more information, please see the INVOCELL Patient Information.