Incubators for Infertility

(VILOCITY Trial)

Overseen By Thomas Molinaro, MD, MSCE

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Reproductive Medicine Associates of New Jersey

Disqualifiers: Failed IVF, Donor oocyte, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

252 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Benchtop Incubator, Multi-room Incubator, Tri-gas Incubator, Compact Incubator, Box Incubator, Conventional Incubator, Standard Incubator, Box CO2 Incubator for infertility?

Research shows that using incubators, like the CO2 gassing incubator, in IVF (in vitro fertilization) can maintain high fertilization rates of around 80% by providing a stable environment for embryos. This suggests that incubators are effective in supporting embryo development during fertility treatments. ^{1 2 3 4 5}

Is the use of incubators for infertility treatment safe for humans?

The research does not provide specific safety data for humans, but it discusses the use of different types of incubators in assisted reproduction, focusing on embryo development and culture conditions. ^{1 2 3 4 6}

How does the Benchtop Incubator treatment for infertility differ from other treatments?

The Benchtop Incubator treatment for infertility is unique because it provides a controlled microenvironment for embryo culture, maintaining stable conditions like temperature and CO2 levels, which are crucial for successful fertilization and embryo development. This approach simplifies the process and improves convenience compared to traditional methods, which may not offer the same level of environmental control. ^{1 3 4 5 7}

What is the purpose of this trial?

The goal of this study is to determine if benchtop incubators improve the number of embryos making it to the blastocyst stage of development (about 4-6 days after fertilization) in people undergoing in vitro fertilization (IVF) treatment for their infertility. * Test the effectiveness of the benchtop incubator. * Determine if the number of embryos reaching the blastocyst stage of embryo development (the stage that the embryos are biopsied for PGT-A and frozen) is improved in the benchtop incubator compared to the box incubator. * Compare embryology outcomes between the two incubator types. * Investigate transfer and pregnancy outcomes. * Expand the knowledge surrounding the impact of the incubator on IVF outcomes. Patients will have their mature oocytes collected at the egg retrieval procedure split into two groups and randomized to be cultured in both incubator types.

Research Team

Thomas Molinaro, MD, MSCE

Principal Investigator

Reproductive Medicine Associates of New Jersey

Eligibility Criteria

This trial is for people undergoing IVF treatment due to infertility. Participants will have their mature oocytes collected and randomly assigned to two groups, each using a different type of incubator (benchtop or box) to culture the embryos.

Inclusion Criteria

I want to transfer the highest quality embryo for my embryo transfer.

4 mature oocytes prior to randomization

My female partner is under 42 years old and starting her egg retrieval cycle.

Exclusion Criteria

My uterus lining is thinner than usual or I have persistent fluid.

Patients with a history of more than one failed euploid embryo transfer

I have hydrosalpinges and no surgery planned before embryo transfer.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Ovarian Stimulation and Oocyte Retrieval

Participants undergo ovarian stimulation and oocyte retrieval per routine

2 weeks

Multiple visits (in-person)

Randomization and Culture

Mature oocytes are split and randomized to be cultured in benchtop or box incubators

1 week

No additional visits required

Blastocyst Assessment

Embryos are cultured to the blastocyst stage and assessed for blastulation rate and morphology

1 week

Follow-up

Participants are monitored for pregnancy outcomes and live birth rate

7 months

Treatment Details

Interventions

• Benchtop Incubator
• Box Incubator

Trial Overview The study aims to compare benchtop and box incubators in terms of improving the number of embryos reaching blastocyst stage during IVF. It also looks at embryology outcomes, transfer success, and pregnancy rates between the two methods.

Participant Groups

Group I: Oocytes allocated to the box incubator Experimental Treatment 1 Intervention

Half of the mature oocytes and subsequent embryos will be cultured in the box incubator

Group II: Oocytes allocated to the benchtop incubator Experimental Treatment 1 Intervention

Half of the mature oocytes and subsequent embryos will be cultured in the benchtop incubator

Benchtop Incubator is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Benchtop Incubator for:

• In Vitro Fertilization (IVF)
• Embryo Culture

Approved in United States as Benchtop Incubator for:

• In Vitro Fertilization (IVF)
• Embryo Culture

Approved in Canada as Benchtop Incubator for:

• In Vitro Fertilization (IVF)
• Embryo Culture

Approved in Japan as Benchtop Incubator for:

• In Vitro Fertilization (IVF)
• Embryo Culture

Approved in China as Benchtop Incubator for:

• In Vitro Fertilization (IVF)
• Embryo Culture

Approved in Switzerland as Benchtop Incubator for:

• In Vitro Fertilization (IVF)
• Embryo Culture

Who Is Running the Clinical Trial?

Reproductive Medicine Associates of New Jersey

Lead Sponsor

Trials

56

Recruited

38,200+

CooperSurgical Inc.

Industry Sponsor

Trials

4

Recruited

650+

Findings from Research

The study presents a simplified method for culturing human eggs and embryos in IVF, using B2/B3-Menezo medium in a multidish system, which allows for easier access and monitoring.

This new approach maintains a high fertilization rate of 80% and stable osmolarity, ensuring that the effectiveness of the IVF process is preserved while improving convenience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A simplified technique for fertilization and culture of human preimplantation embryos in vitro. Feichtinger, W., Kemeter, P.[2004]

The study reviews how different incubator management practices can significantly impact the outcomes of assisted reproductive technology (ART), focusing on fertilization rates, embryo development, and clinical pregnancy rates.

Key factors in incubator management include the environmental conditions for culturing human and bovine oocytes/embryos, such as their positions within the incubator, air quality, and overall quality control, which are crucial for optimizing ART success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incubator management in an assisted reproductive technology laboratory. Higdon, HL., Blackhurst, DW., Boone, WR.[2013]

The mini-incubator demonstrated superior microenvironment maintenance, recovering temperature and oxygen levels much faster than the conventional incubator, which took 5 minutes and 30 minutes respectively after a brief door opening.

Embryos cultured in the mini-incubator had significantly higher rates of good embryo formation (39.5%) and good blastocyst formation (15.1%) compared to those in the conventional incubator (28.4% and 7.8%), indicating better outcomes for embryo development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of micro-environment maintenance on embryo culture after in-vitro fertilization: comparison of top-load mini incubator and conventional front-load incubator. Fujiwara, M., Takahashi, K., Izuno, M., et al.[2018]

Adding an outer-well medium to IVF culture dishes significantly reduced harmful osmotic changes caused by evaporation in a dry-type incubator, leading to better pregnancy outcomes.

In IVF-ET cycles, the humid culture conditions resulted in lower abortion rates and higher ongoing pregnancy rates compared to dry conditions, highlighting the importance of maintaining optimal osmotic balance during embryo culture.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of evaporation-induced osmotic changes in culture media in a dry-type incubator on clinical outcomes in in vitro fertilization-embryo transfer cycles. Chi, HJ., Park, JS., Yoo, CS., et al.[2020]

An international expert meeting established over 50 consensus guidelines for optimal in vitro fertilization (IVF) culture conditions, focusing on critical factors like temperature, humidity, and oxygen levels that affect embryo development.

The guidelines emphasize the importance of maintaining a stable culture environment and proper handling practices to enhance the success rates of IVF procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

'There is only one thing that is truly important in an IVF laboratory: everything' Cairo Consensus Guidelines on IVF Culture Conditions. Consensus Group, C.[2021]

Embryos cultured in a time lapse system (TLS) had a higher blastocyst formation rate (55%) compared to those in a standard incubator (45%), indicating that the type of incubator can significantly enhance embryo development.

The TLS also altered amino acid utilization, showing increased total amino acid uptake and reduced production, which suggests that the culture environment affects embryo metabolism, although there was no difference in clinical pregnancy rates between the two incubator types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Incubator type affects human blastocyst formation and embryo metabolism: a randomized controlled trial. Kermack, AJ., Fesenko, I., Christensen, DR., et al.[2022]

The Oxoid CO2Gen gas generating system, which creates a suitable atmosphere for embryo development, showed comparable effectiveness to a standard CO2 incubator in supporting bovine in vitro oocyte maturation, fertilization, and embryo development, with similar blastocyst rates in both systems.

This study, involving a total of 2,729 inseminated oocytes, suggests that the Oxoid system is a cost-effective and stable alternative for in vitro embryo production, potentially making the process more accessible without compromising embryo quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel approach for in vitro production of bovine embryos: use of the Oxoid atmosphere generating system. Avery, B., Melsted, JK., Greve, T.[2019]

References

1. Italy pubmed.ncbi.nlm.nih.gov

A simplified technique for fertilization and culture of human preimplantation embryos in vitro. [2004]

2. United States pubmed.ncbi.nlm.nih.gov

Incubator management in an assisted reproductive technology laboratory. [2013]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Effect of micro-environment maintenance on embryo culture after in-vitro fertilization: comparison of top-load mini incubator and conventional front-load incubator. [2018]

4. Korea (South) pubmed.ncbi.nlm.nih.gov

Effect of evaporation-induced osmotic changes in culture media in a dry-type incubator on clinical outcomes in in vitro fertilization-embryo transfer cycles. [2020]

5. Netherlands pubmed.ncbi.nlm.nih.gov

'There is only one thing that is truly important in an IVF laboratory: everything' Cairo Consensus Guidelines on IVF Culture Conditions. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Incubator type affects human blastocyst formation and embryo metabolism: a randomized controlled trial. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

A novel approach for in vitro production of bovine embryos: use of the Oxoid atmosphere generating system. [2019]