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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Infertility
• Intervention / Treatment: Other: Benchtop Incubator; Other: Box Incubator

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.

• Study Type: Interventional
• Enrollment (Estimated): 252
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Christine V Whitehead, BSN, RN; Phone Number: 19736562841; Email: clinicalresearchteam@ivirma.com
• Study Contact Backup: Name: Caroline Zuckerman, BS, RN; Phone Number: 19736562841; Email: clinicalresearchteam@ivirma.com

Study Locations

• United States
  • New Jersey
    • Basking Ridge, New Jersey, United States, 07920
      • Recruiting
      • Reproductive Medicine Associates of New Jersey
      • Contact: Christine V Whitehead, BSN, RN; Phone Number: 19736562841; Email: clinicalresearchteam@ivirma.com
      • Principal Investigator: Thomas Molinaro, MD, MSCE
      • Contact: Caroline M Zuckerman, BS, RN; Phone Number: 973-656-2841; Email: clinicalresearchteam@ivirma.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Oocytes allocated to the benchtop incubator; Half of the mature oocytes and subsequent embryos will be cultured in the benchtop incubator	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: Oocytes allocated to the box incubator; Half of the mature oocytes and subsequent embryos will be cultured in the box incubator	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blastulation Rate per mature oocyte (M2)	count of blastocyst stage embryos per M2 count	approximately 1 week post oocyte retrieval procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fertilization Rate	count of fertilized zygotes (2 pronuclei (2PN)) per M2 count	approximately 24 hours post oocyte retrieval procedure
Blastulation Rate per 2PN	count of blastocyst stage embryos per 2PN	approximately 1 week post oocyte retrieval procedure
Ploidy rates	Rates of whole chromosome negative and positive preimplantation genetic testing for aneuploidy (PGT-A) results per blastocyst	approximately 2 weeks post blastocyst trophectoderm biopsy
Sustained implantation rate (SIR)	rate of ongoing pregnancy at 8-9 weeks gestational age when discharged to obstetrician	6 weeks post embryo transfer
Live birth rate	rate of live born infants	approximately 7 months after discharge to obstetrician
Embryologist Questionnaire	assess efficiency in the lab between the two incubators and other questions from the embryologist's perspectives	upon primary outcome completion in approximately 18 months
Blastocyst Morphology using Modified Gardner Scale	Morphology Grade at time of trophectoderm biopsy and vitrification. Expansion 1-6. Inner cell mass and trophectoderm graded A-D.	approximately 1 week post oocyte retrieval procedure

Collaborators and Investigators

• Sponsor: Reproductive Medicine Associates of New Jersey
• Collaborators: CooperSurgical Inc.
• Investigators: Principal Investigator: Thomas Molinaro, MD, MSCE, Reproductive Medicine Associates of New Jersey

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2023
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: October 25, 2023
• First Submitted That Met QC Criteria: January 16, 2024
• First Posted (Actual): January 22, 2024

Study Record Updates

• Last Update Posted (Actual): January 24, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Infertility
• Other Study ID Numbers: 2206-BRG-075-CW

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No