Clinical trial NCT06214936: Validating Incubators in the Lab: Optimizing Culture and Investigating blasTulation Yield
Official title: The VILOCITY Trial: Validating Incubators in the Lab: Optimizing Culture and Investigating blasTulation Yield: a Randomized Control Trial (RCT)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infertility
Lead sponsor: Reproductive Medicine Associates of New Jersey
Sponsor class: OTHER
Collaborators: name: CooperSurgical Inc.
First posted: 2024-01-22
Enrollment: 252
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 41
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Eligibility criteria: 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. 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 Criteria for participants:

1. All patients who do not voluntarily give their written consent for participation
2. Patients with a prior failed IVF cycle - defined as no blastocysts
3. Patients with a history of more than one failed euploid embryo transfer
4. Donor oocyte cycles
5. Gestational Carriers
6. Male partner with \<100,000 total motile spermatozoa per ejaculate (donor sperm is acceptable)
7. Use of surgical procedures to obtain sperm
8. Communicating hydrosalpinges without a plan for surgical correct prior to frozen embryo transfer
9. Endometrial Insufficiency, as defined by a prior cycle with maximal endometrial thickness \<6mm,), or persistent endometrial fluid
10. Single gene disorders, chromosomal translocations, or any other disorders requiring a more detailed embryo genetic analysis

Primary outcomes:
measure: Blastulation Rate per mature oocyte (M2)
timeFrame: approximately 1 week post oocyte retrieval procedure
Secondary outcomes:
measure: Fertilization Rate
timeFrame: approximately 24 hours post oocyte retrieval procedure
measure: Blastulation Rate per 2PN
timeFrame: approximately 1 week post oocyte retrieval procedure
measure: Blastocyst Morphology using Modified Gardner Scale
timeFrame: approximately 1 week post oocyte retrieval procedure
measure: Ploidy rates
timeFrame: approximately 2 weeks post blastocyst trophectoderm biopsy
measure: Sustained implantation rate (SIR)
timeFrame: 6 weeks post embryo transfer
measure: Live birth rate
timeFrame: approximately 7 months after discharge to obstetrician
measure: Embryologist Questionnaire
timeFrame: upon primary outcome completion in approximately 18 months
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Reproductive Medicine Associates of New Jersey
state: New Jersey
Study officials:
affiliation: Reproductive Medicine Associates of New Jersey
name: Thomas Molinaro, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References: