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)
Reproductive Medicine Associates of New Jersey
252 participants
Dec 19, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria9
- Patients undergoing an IVF cycle with plan for subsequent frozen embryo transfer (FET) of a single euploid embryo
- 4 mature oocytes prior to randomization
- Female partners age <42 years old at start of their vaginal oocyte retrieval (VOR) cycle
- Normal ovarian reserve:
- Antimullerian Hormone Level (AMH) ≥ 1.2 ng/mL
- Antral Follicle Count (AFC) ≥ 8
- Follicle Stimulating Hormone (FSH) FSH ≤ 12international units (IU)/L
- Body Mass Index (BMI) <35
- Patients who desire to transfer the best quality embryo for their embryo transfer. However, if a participant ends up electing to transfer based on sex preference after enrollment these outcomes will still be followed and included in the intention to treat analysis.
Exclusion Criteria10
- All patients who do not voluntarily give their written consent for participation
- Patients with a prior failed IVF cycle - defined as no blastocysts
- Patients with a history of more than one failed euploid embryo transfer
- Donor oocyte cycles
- Gestational Carriers
- Male partner with <100,000 total motile spermatozoa per ejaculate (donor sperm is acceptable)
- Use of surgical procedures to obtain sperm
- Communicating hydrosalpinges without a plan for surgical correct prior to frozen embryo transfer
- Endometrial Insufficiency, as defined by a prior cycle with maximal endometrial thickness <6mm,), or persistent endometrial fluid
- Single gene disorders, chromosomal translocations, or any other disorders requiring a more detailed embryo genetic analysis
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
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
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
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06214936