Optimizing embryo development in IVF using different incubators

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

This study is testing if using a new type of incubator can help more embryos develop successfully during IVF treatments.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 252 (estimated)
• Ages: 18 Years to 41 Years
• Sex: Female
• Sponsor: Reproductive Medicine Associates of New Jersey (Academic / other)
• Locations: 1 site (Basking Ridge, New Jersey)
• Trial ID: NCT06214936 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate whether benchtop incubators can enhance the number of embryos reaching the blastocyst stage during in vitro fertilization (IVF) treatments. Participants undergoing IVF will have their mature oocytes divided into two groups, with one group cultured in a benchtop incubator and the other in a conventional box incubator. The study will compare embryology outcomes, including blastocyst formation rates and subsequent pregnancy outcomes, while maintaining blinding for participants and clinical staff. The goal is to expand knowledge on how incubator type impacts IVF success rates.

Who should consider this trial

Good fit: Ideal candidates are women under 42 years old undergoing IVF with a plan for frozen embryo transfer and who have at least four mature oocytes.

Not a fit: Patients who have previously failed IVF cycles or do not meet the eligibility criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved embryo development and higher pregnancy rates for patients undergoing IVF.

How similar studies have performed: While the specific use of benchtop incubators in this context may be novel, similar studies have shown that optimizing culture conditions can improve IVF outcomes.

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

Where this trial is running

Basking Ridge, New Jersey

• Reproductive Medicine Associates of New Jersey — Basking Ridge, New Jersey, United States (Recruiting)

Study contacts

• Principal investigator: Thomas Molinaro, MD, MSCE — Reproductive Medicine Associates of New Jersey
• Study coordinator: Caroline Zuckerman, BS, RN

Conditions Infertility