WHY INVOCELL

INVOCELL and your
fertility journey

When facing fertility challenges, some of the options most
commonly offered to women are
intrauterine insemination
(IUI) and in vitro fertilization (IVF). INVOCELL
was designed to give
women, and their partners,
another option on their fertility journey.

Here is how IVC with INVOCELL could fit among some
of the options used in fertility treatment.

In one study, IUI was
reported to
have an
8-10% rate of success,
with success defined
as
pregnancy rates per
cycle,
including live
births and
ongoing
pregnancies.

A clinical trial of
IVC with
INVOCELL
resulted in about a
25% success rate,
which was
defined
as the number of live
births per embryo
transfer.

In nationally reported data,
IVF demonstrated
up to a
48% success
rate,
where
success
was defined as the
rate
of live births per cycle.

How INVOCELL can
help meet your fertility
treatment needs

In a clinical trial, about 1 in 4 embryo transfers resulted in a birth

INVOCELL was studied in a clinical trial involving 450 cycles, 421 of which resulted in embryo transfers. Of these transfers, about 1 in 4 resulted in a birth.

It’s important to know: adverse pregnancy events, like miscarriage and pre-term births, were reported in the clinical study, as these were primarily related to the effectiveness of the device (live birth rate).

An innovative option that considers your concerns about treatment costs

The use of mild ovarian stimulation and fewer monitoring visits, as decided by your doctor, could reduce some of the costs of treatment with INVOCELL. Talk to your doctor about what is best for you.

Unique method that uses your own body as an incubator

INVOCELL uses a unique approach that allows you to be an even greater part of the process. Your doctor will place the eggs and sperm in the INVOCELL device, and then position the device in your vagina. Your body provides the environment needed for fertilization and incubation to occur.

Used with mild ovarian stimulation

Your doctor will prescribe medicine to help your body produce eggs. Once the eggs are retrieved, they are placed in the INVOCELL device with sperm.

May require fewer monitoring visits, as decided by your doctor

With INVOCELL, you may need fewer monitoring visits, which may mean fewer disruptions to your schedule. And, as always, your doctor will work with you to decide on the right number of follow-up visits.

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.

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.
Please see Indication and Select Important Safety Information