NCT06214936

Validating Incubators in the Lab: Optimizing Culture and Investigating blasTulation Yield

The VILOCITY Trial: Validating Incubators in the Lab: Optimizing Culture and Investigating blasTulation Yield: a Randomized Control Trial (RCT)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 252 (estimated)
• Sponsor: Reproductive Medicine Associates of New Jersey · Academic / Other
• Sex: Female
• Age: 18 Years – 41 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

The proposed study is a prospective, split cohort, randomized controlled trial which seeks to characterize blastocyst formation rates following culture in a benchtop incubator in comparison to a box incubator. Following enrollment, participants will undergo ovarian stimulation and oocyte retrieval per routine as previously consented to at the clinic. IVF stimulation protocol will be at the discretion of the participant's individual provider, per routine. Those participants that develop 4 or more mature oocytes will proceed with randomization. Intracytoplasmic Sperm Injection (ICSI) will be performed, as well as assisted hatching on day 3 and embryos will be cultured to the blastocyst stage per routine. It is important to note that there are no changes to the routine embryology care itself, the only difference within the study is that the participant's cohort of oocytes will be split into two groups and randomized to placement within each type of incubator (benchtop and conventional box incubator). The participant, physician, and the clinical team will all be blinded to the randomization of the oocytes and subsequent embryos until study completion. All embryologists making any assessments or selecting the embryo for transfer will also be blinded.

Conditions

• Infertility

Interventions

Type	Name	Description
OTHER	Benchtop Incubator	half of the mature oocytes will be placed in the benchtop incubator and after ICSI the resulting inseminated oocytes and subsequent embryos will remain in the benchtop incubator for the remainder of embryo culture
OTHER	Box Incubator	half of the mature oocytes will be placed in the benchtop incubator and after ICSI the resulting inseminated oocytes and subsequent embryos will remain in the box incubator for the remainder of embryo culture

Timeline

• Start date: 2023-12-19
• Primary completion: 2025-06-01
• Completion: 2026-06-01
• First posted: 2024-01-22
• Last updated: 2025-02-07

Locations

1 site across 1 country: United States