Frequently Asked Questions

Why you should consider the INVO® Solution

We know choosing a fertility treatment can be a challenging experience. Finding the right physician under any circumstance can be a daunting task. Patients seeking help with fertility may be faced with even more complicated medical decisions.

Here are some things you should know about the INVOcell® Device and the INVO Procedure.

The INVO Solution:

  • Allows women to incubate their own gametes, providing a psychological benefit while reducing the risk of wrong embryo transfer
  • Uses Mild Stimulation protocols and decreases the number of oocytes required, which may:
    • Reduce the risk of severe ovarian hyperstimulation (OHSS)
    • Reduce the risk of multiple births
    • Reduce the need for embryo cryopreservation and storage
  • Can be successfully utilized in place of Intrauterine insemination (IUI), which may:
    • Increase success rate as IUI only achieves a general success rate of 10%
    • Decrease the number and cost of procedures as IUI often requires multiple procedures compared to a single INVO cycle
  • Expands new patient base in IVF centers by offering an alternative affordable treatment to those who cannot afford the traditional method or would prefer for a more natural, cultural, or religious appropriate choice
  • Is a lower cost option, as INVO:
    • Can be performed outside an IVF center significantly reducing overhead
    • Reduces the use of carbon dioxide incubators and backup systems
    • Expands access to a larger geographical area, reducing or eliminating travel and providing substantial cost savings to patients
    • Reduces equipment required in an OB/GYN’s office in the US (<$50,000) compared to the cost to build an IVF center (> $500,000)

If you would like more information please read through our Frequently Asked Questions (FAQ) below or contact us for further details. Thank you.

INVO Procedure Using the INVOcell Culture System

What is the INVO Procedure also called Intravaginal Culture?

The INVO Procedure is an assisted reproduction technique where oocyte fertilization and early embryo development are carried out within the patented INVOcell, a gas permeable device placed into the maternal vaginal cavity for incubation.  The terms In Vivo Fertilization and Vaginal Incubation are also used to describe the INVO Procedure.

INVO Diagram_V3

What does the INVOcell System consist of?

The INVOcell Intravaginal Culture System (also referred to as INVOcell Culture System or Vaginal Incubation system) consists of the INVOcell Culture Device, the INVOcell Retention Device, and the INVOcell Holding Block.

What is the INVOcell Culture Device?

The  INVOcell  Culture  Device  is indicated  for use  in preparing, holding, and  transferring human gametes or embryos during In Vivo Fertilization/Intravaginal Culture (IVF/IVC) and Intra-cytoplasmic Sperm Injection Fertilization/Intravaginal Culture (ICSI/IVC) procedures. The INVOcell Culture Device is indicated for use with the INVOcell Retention Device and the INVOcell Holding Block. The INVOcell Culture Device is not indicated for incubation periods exceeding 72 hours (3 days).

Note:  The INVOcell Culture Device consists of an inner vessel surrounded by an outer rigid shell. The inner vessel holds culture medium, eggs and sperm, or ICSI fertilized embryos. The inner vessel is placed into the outer rigid shell, which provides additional resistance to contamination.

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What are the materials used in the INVOcell Device and are they toxic to the embryo?

MATERIALS

The inner vessel of the INVOcell Device is made of medical grade polystyrene and non-latex synthetic rubber / thermoplastic elastomer (TPE) with a silicone o-ring. The outer rigid shell of the INVOcell Device is made of medical grade polystyrene and a large silicone o-ring.

The INVOcell Device is non-pyrogenic and is endotoxin tested by LAL yielding no more than 20 EU/device.

The INVOcell Device (inner vessel) is non-embryo toxic and has been tested for embryo toxicity yielding at least 80 % of 2-cell mouse embryos reaching the blastocyst stage.

What is the INVOcell Retention Device?

The  INVOcell  Retention  Device  is indicated  for use  with  the  INVOcell  Device to  aid  in retention of the  INVOcell  Device in the  vaginal cavity during the incubation period.   The INVOcell Retention Device is not indicated for use exceeding 72 hours.

Note: The INVOcell retention system is made of medical grade silicone and is cylinder in shape with a perforated membrane allowing the normal flow of the vaginal secretions.

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What is the INVOcell Holding Block?

The INVOcell Holding Block is indicated for use with the INVOcell Device to aid in temperature maintenance of the INVOcell Device during loading and collection procedures and to aid in positioning and observation of the INVOcell Device during human gamete/embryo loading and collection procedures. The INVOcell Holding Block is stainless steel with a glass-viewing window.

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What type of media is recommended for use with the INVOcell Device?

We recommend in the instructions for use (IFU) that reproductive centers using INVO, utilize a legally-marketed ART culture medium that will support continued embryonic development for up to 72 hours (3 days).

How many eggs/sperm does the INVOcell Device hold?

We decreased the sperm concentration to 30,000 motile sperm/mL to get the best fertilization rate and embryo development. No more than 7 eggs can be placed in the INVOcell Device.

How is the quality of embryos determined and selected?

Embryo quality is determined and selected through direct observation by qualified clinicians and/or embryologists as would similarly occur in traditional IVF.

INVO Treatment Cycle

Is there a limit on the number of cycles a couple can undergo?

The number of INVO cycles a couple can undergo is a decision you and your physician determine after consultation and evaluation. We recommend performing three INVO attempts if fertilization and embryo transfer have not been obtained during the first two procedures. If fertilization has not been obtained during the first INVO attempt, additional consultation may be required by your physician as to the course of your fertility treatment plan.

Do I have to take drugs to stimulate the ovaries?

The INVO Procedure has always been combined with natural or mild ovarian stimulation protocols, generally recruiting less than 10 follicles. Your physician will determine the type and quantity of drugs required to recruit the number of follicles based on your fertility treatment plan. If your physician prescribes hormonal injections to stimulate your ovaries, the amount of these drugs will usually be a lot lower than the amount of drugs used in ovarian hyper-stimulation protocols for conventional IVF. These injections may be administered by a nurse, clinician or by yourself following instructions.

Why is the INVOcell Device incubated inside the vaginal cavity?

Incubation inside the vaginal environment provides the optimal “natural” conditions (gas and temperature) for proper embryo development.

Why the 72-hour incubation period?

It is the optimal time, demonstrated through clinical trials, that oocyte fertilization and healthy embryo development prior to transfer.

It was also the period of incubation cleared by the FDA.

Can the INVOcell be incubated without the retention device?

In rare circumstances, this may be required if the patient cannot tolerate the retention device in the vaginal cavity. In this case the female patient would need to limit her daily activity and take additional precautions. Your physician will advise and provide you with Patient Instructions.

What happens to the device after the procedure?

The device is single-use only and will be discarded appropriately by the physician.

What happens if there are extra eggs retrieved?

Excess of eggs will be handled according to the reproductive center’s policy and patient’s preference. These eggs may be cryopreserved in case of future use or discarded if quality will not allow future fertilization.

Can I inspect the INVOcell at home during the 3-day incubation period?

No, we strongly advise to not remove the device during the entire incubation period. It may affect temperature and gas levels leading to defective embryo development.

What’s the difference between the INVO procedure and traditional IVF?

Traditional IVF is complex, uses sophisticated equipment, requires many gamete and embryo manipulations and uses a CO2  or Tri-gas incubator. The INVO procedure is simpler, more natural and uses the vaginal cavity as the source of incubation.  The INVO procedure is approximately half the cost of traditional IVF.

Success Rate and Benefits

Am I guaranteed to have a baby under the INVO procedure?

No fertility treatments can guarantee clinical pregnancy or the birth of a baby.

How many babies have been born as a result of the INVO procedure?

INVO is a new innovative procedure cleared by the FDA in November 2015. Several hundred babies have been born as the result of the INVO Procedure in the U.S. and all around the world.

What are the outcomes of INVO cycles performed during clinical use?

The INVO/ Intravaginal Culture System was evaluated in fertility clinics in Colombia, Bolivia, Brazil, and Peru. A total of 450 INVO/ Intravaginal Culture cycles were performed.  330 of the cycles were INVO/ In-vitro Fertilization (INVO/IVF), and 120 cycles were INVO/ ICSI resulting in 132 live born babies. The following tables summarize outcomes for patients who used INVO instead of IVF and patients who used INVO incubation after intracytoplasmic sperm injection (ICSI) of their oocytes:

Table 1: COMPARE OUTCOMES OF INVO/IVF AND INVO/ICSI CYCLES

INVO / IVFINVO / ICSI
Cycles330120
Embryo Transfers308 (93% of cycles)113 (94% of cycles)
Born Babies9834

 

Table 2: OUTCOMES OF THE 450 INVO CYCLES

INVO Cycles (IVF + ICSI)
Cycles450
Clinical Pregnancies146
Clinical Pregnancy Rate34.2%
Miscarraige Rate22.6%
Multiple Pregnancy Rate15.1%
Birth Rate23.8%
Multiple Birth Rate17.8%
Triplet Births6
Twin Births13
Births from Singleton Pregnancies88
Triple Pre-term Births (%)6 (100%)
Twin Pre-term Births7 (53.8%)
Singleton Pre-term Births from Single Pregnancies0
Pre-term Birth Rate21.4%

Why consider the INVO Procedure over traditional IVF?

The INVO Procedure using the INVOcell System offers many benefits while achieving equivalent safety and effectiveness compared to traditional IVF.

The benefits of the INVO procedure are substantiated by clinical trial data collected on 450 cycles. Success rate and clinical outcomes are comparable to traditional IVF and the additional psychological benefits with the use of the device are not available with traditional IVF and use of external incubators.

What are the key benefits of INVO?

Provides psychological benefits to patients /couples and promotes greater involvement by couples

One of the most important benefits of the INVO procedure is the psychological benefit provided to couples who desire to carry their gametes/embryos rather than letting them reside in an incubator under the clinic’s control.  A significant psychological benefit is created among the patients who feel closely involved in the process of fertilization and early embryo development, which also generates a high level of acceptance of the procedure.

Provides a more natural and stable environment using vaginal incubation than using conventional IVF incubation in an incubator

With the INVO procedure, the temperature and gas concentration stays stable throughout the incubation period since there is no major variation of the incubation environment as it can occur in incubators due to the opening and closing of the incubator doors as well as the cycling of the temperature (thermostat) of the laboratory room where incubators are stored.  The INVOcell Device would not be able to maintain the pH of the culture medium if the temperature and gas concentration did not stay stable throughout the incubation period. The pH testing successfully demonstrated a stable gas environment.

Reduces the risk of wrong embryo transfers

Wrong patient embryo transfers are a documented risk with current IVF procedures. The INVO procedure reduces the risk of wrong embryo transfers.  With the INVO procedure: at the time of the oocyte retrieval, the physician immediately places the oocytes into the device then adds the sperm of the conjoint which was prepared just before the egg retrieval.  The device is then placed in the vaginal cavity. However, if the sperm is prepared outside the INVO laboratory, it is still possible that wrong sperm could be used.  After incubation, the INVOcell Device is removed from the vagina, the resulting embryos are aspirated at that time and the highest quality embryo(s) is loaded in a catheter and transferred in the uterus.  Because the fertilization and embryo development does not occur in incubators that hold many couples’ gametes, there is still a reduction in the risk of wrong identification during embryo transfers with the use of the INVO procedure compared to traditional IVF.

Reduces the cost of IVF and increases geographic accessibility

There are many benefits of the INVO procedure; the overall benefit is having a simpler procedure that reduces overhead and infrastructure costs compared to traditional IVF. With the INVO procedure, more patients have access to treatment. In the US, the majority of states do not have healthcare coverage for Assisted Reproductive Technology (ART) procedures and the infertile couples must pay for treatment themselves. The cost of traditional IVF definitely limits treatment to many couples because they cannot afford it.   In an ASRM press release (2014) that discusses the benefits of the INVO procedure, Charles Coddington, MD, President of the Society for Assisted Reproductive Technology, stated, “These studies show how innovative technology may be able to reduce some of the laboratory costs and lead to wider availability of treatment.” (ASRM, 2014)

How will the INVO procedure benefit the availability of ART services?

The potential for INVO to increase the geographic availability of ART services cannot be overstated worldmedicalguide.com.  Currently, the availability of IVF services is generally confined to larger metropolitan areas.  This limits access to couples who live and/or work in these metropolitan areas.  The reasons for lack of availability in most mid-size cities are multiple.

A major expense of traditional IVF relates to the perceived need for intensive monitoring with sonography and STAT estradiol measurements.

The INVO procedure has been always combined with mild ovarian stimulation protocols result