Actively Recruiting
Validating Incubators in the Lab: Optimizing Culture and Investigating blasTulation Yield
Led by Reproductive Medicine Associates of New Jersey · Updated on 2025-02-07
252
Participants Needed
1
Research Sites
127 weeks
Total Duration
On this page
Sponsors
R
Reproductive Medicine Associates of New Jersey
Lead Sponsor
C
CooperSurgical Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Validating Incubators in the Lab: Optimizing Culture and Investigating blasTulation Yield
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients undergoing an IVF cycle with plan for subsequent frozen embryo transfer of a single euploid embryo
- At least 4 mature oocytes prior to randomization
- Female age under 42 years at start of vaginal oocyte retrieval
- Normal ovarian reserve defined by:
- Antimullerian Hormone (AMH) level of 1.2 ng/mL or higher
- Antral Follicle Count (AFC) of 8 or more
- Follicle Stimulating Hormone (FSH) level 12 IU/L or less
- Body Mass Index (BMI) less than 35
- Desire to transfer the best quality embryo for embryo transfer
You will not qualify if you...
- Patients who do not give written consent for participation
- Prior failed IVF cycle with no blastocysts
- History of more than one failed euploid embryo transfer
- Donor oocyte cycles
- Gestational carriers
- Male partner with less than 100,000 total motile sperm per ejaculate (donor sperm acceptable)
- Use of surgical procedures to obtain sperm
- Communicating hydrosalpinges without surgical correction planned before frozen embryo transfer
- Endometrial insufficiency defined by prior cycle with endometrial thickness under 6 mm or persistent endometrial fluid
- Single gene disorders, chromosomal translocations, or other disorders requiring detailed embryo genetic analysis
AI-Screening
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Trial Site Locations
Total: 1 location
1
Reproductive Medicine Associates of New Jersey
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
Research Team
C
Caroline Zuckerman, BS, RN
CONTACT
C
Christine V Whitehead, BSN, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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