The VILOCITY Trial: Validating Incubators in the Lab: Optimizing Culture and Investigating blasTulation Yield: a Randomized Control Trial (RCT)
Reproductive Medicine Associates of New Jersey
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.
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 per…
Eligibility
- Age range
- 18–41 years
- Sex
- Female
- Healthy volunteers
- No
Inclusion Criteria for participants: 1. Patients undergoing an IVF cycle with plan for subsequent frozen embryo transfer (FET) of a single euploid embryo 2. 4 mature oocytes prior to randomization 3. Female partners age \<42 years old at start of their vaginal oocyte retrieval (VOR) cycle 4. Normal ovarian reserve: 1. Antimullerian Hormone Level (AMH) ≥ 1.2 ng/mL 2. Antral Follicle Count (AFC) ≥ 8 3. Follicle Stimulating Hormone (FSH) FSH ≤ 12international units (IU)/L 5. Body Mass Index (BMI) \<35 6. Patients who desire to transfer the best quality embryo for their embryo transfer.…
Interventions
- OtherBenchtop 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
- OtherBox 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
Location
- Reproductive Medicine Associates of New JerseyBasking Ridge, New Jersey