Infertility Clinical Trials

Find Infertility Clinical Trials Near You

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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 41
Healthy Volunteers: f
View:

• 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.

Locations
United States
New Jersey
Reproductive Medicine Associates of New Jersey
RECRUITING
Basking Ridge
Contact Information
Primary
Caroline Zuckerman, BS, RN
clinicalresearchteam@ivirma.com
19736562841
Backup
Christine V Whitehead, BSN, RN
clinicalresearchteam@ivirma.com
19736562841
Time Frame
Start Date: 2023-12-19
Estimated Completion Date: 2026-06
Participants
Target number of participants: 252
Treatments
Other: Oocytes allocated to the benchtop incubator
Half of the mature oocytes and subsequent embryos will be cultured in the benchtop incubator
Other: Oocytes allocated to the box incubator
Half of the mature oocytes and subsequent embryos will be cultured in the box incubator
Related Therapeutic Areas
Sponsors
Collaborators: CooperSurgical Inc.
Leads: Reproductive Medicine Associates of New Jersey

This content was sourced from clinicaltrials.gov