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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a benchtop incubator can improve the chances of embryos reaching the blastocyst stage during IVF treatment for infertility. Researchers will compare benchtop incubators with traditional box incubators to determine which more effectively nurtures embryos. The study will also examine pregnancy outcomes to assess if the incubator type influences results. It suits individuals undergoing IVF with at least four mature eggs, planning to use a frozen embryo transfer, and aiming to select the best quality embryo. As an unphased trial, this study allows participants to contribute to innovative research that could enhance IVF success rates.

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 prior data suggests that these incubators are safe for IVF procedures?

Research has shown that benchtop incubators are specifically designed for use in IVF (in vitro fertilization) clinics and are popular in this field. Studies indicate that these smaller incubators can quickly restore gas and temperature levels, which is crucial for maintaining a stable environment for embryo growth. However, some reports suggest that benchtop incubators might struggle to maintain a consistently stable environment, which could be a drawback.

Box incubators, in contrast, are designed to provide a stable environment for embryo development. Some research suggests that benchtop incubators might be more effective at producing early-stage embryos, known as blastocysts, compared to box incubators. Nevertheless, both types of incubators aim to support embryo development effectively.

In summary, both benchtop and box incubators have their advantages and disadvantages. No evidence indicates any major safety issues with using either type for embryo development in IVF. For those considering participation in a clinical trial involving these incubators, both are generally regarded as safe and effective in the IVF process. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores two different types of incubators—benchtop and box incubators—for culturing oocytes and embryos in infertility treatments. Typically, incubators are essential in providing the right environment for embryos to develop outside the human body, but the specific design and technology can vary. This trial seeks to discover whether these two incubator types can improve the success rates of embryo development by comparing their effectiveness. By investigating these differences, researchers hope to enhance current infertility treatment protocols and potentially increase the chances of successful pregnancies.

What evidence suggests that these incubators are effective for improving embryo development in IVF?

In this trial, researchers will allocate oocytes to either benchtop incubators or box incubators. Research has shown that benchtop incubators might enhance embryo growth during in vitro fertilization (IVF). These incubators quickly return to the optimal temperature and gas levels after being opened, maintaining ideal conditions for embryo growth. Some studies have found that embryos in benchtop incubators are more likely to reach the blastocyst stage. Conversely, box incubators, while providing a stable environment, may not return to ideal conditions as swiftly after being opened. Both incubator types support embryo growth, but benchtop incubators might better maintain optimal conditions for successful embryo development. ^{6 7 8 9 10}

Who Is on the Research Team?

Thomas Molinaro, MD, MSCE

Principal Investigator

Reproductive Medicine Associates of New Jersey

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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 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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8176153/

Comparison of pregnancy outcomes using a time-lapse ... The aim of this study was to compare the pregnancy outcomes of in vitro fertilization with embryo transfer between embryos cultured in a time-lapse monitoring ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0015028221020483

Common practices among consistently high-performing in ... The smaller chambers in benchtop incubators have been shown to facilitate faster temperature and atmosphere recovery after opening compared with larger chambers ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11191516/

A novel method for gas mixing and distribution in multi ... In this study, we propose a novel gas mixing and distribution system and method as an alternative solution for multi-chamber embryo incubators.

4. geneabiomedx.com geneabiomedx.com/geneabiomedx/benchtop-and-timelapse-incubators-in-human-ivf-impacts-on-outcomes-workflow-efficiencies-and-ai-integration/

Benchtop and Time-Lapse Incubators in Human IVF This blog post will discuss these two types of incubators, focusing on their impact on IVF outcomes and laboratory workflow efficiencies.

5. fertstert.org fertstert.org/article/S0015-0282(21)00988-2/fulltext

PREDICTIVE CUMULATIVE LIVE-BIRTH RATE BASED ... The study found that live birth rates in time-lapse incubators were comparable, with pool medium slightly higher. Cumulative birth rates were higher in pool ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6000787/

Considerations Regarding Embryo Culture Conditions The IVF community has favored the bench-top incubator in practice in view of ... Bench-top incubators are the only type explicitly designed for clinical IVF use.

7. rbmojournal.com rbmojournal.com/article/S1472-6483(14)00056-X/fulltext

comparative analysis of embryo culture incubators Smaller incubator units, especially benchtop/topload devices, result in faster gas atmosphere and temperature recovery. However, no study has clearly ...

8. academic.oup.com academic.oup.com/humrep/article/37/12/2757/6775035

Incubator type affects human blastocyst formation and embryo ... One of the major drawbacks with using a standard benchtop incubator is the inability to maintain a continuous, stable culture environment due to ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10310598/

Humidified atmosphere in a time-lapse embryo culture ... These results suggest that HC conditions do not improve the rate of ongoing pregnancy and several embryological outcomes.

10. mdpi.com mdpi.com/2076-3417/14/16/7411

Novel Gas Supply System for Multi-Chamber Tri-Gas Cell ... Both types of incubators have an internal volume of approximately 180 L, resulting in a gas concentration recovery time of over 60 min after ...