Status:
RECRUITING
Validating Incubators in the Lab: Optimizing Culture and Investigating blasTulation Yield
Lead Sponsor:
Reproductive Medicine Associates of New Jersey
Collaborating Sponsors:
CooperSurgical Inc.
Conditions:
Infertility
Eligibility:
FEMALE
18-41 years
Phase:
NA
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 i...
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 i...
Eligibility Criteria
Inclusion
- Inclusion Criteria for participants:
- 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.
- Exclusion Criteria for participants:
- All patients who do not voluntarily give their written consent for participation
- Patients with a prior failed IVF cycle - defined as no blastocysts
- Patients with a history of more than one failed euploid embryo transfer
- Donor oocyte cycles
- Gestational Carriers
- Male partner with \<100,000 total motile spermatozoa per ejaculate (donor sperm is acceptable)
- Use of surgical procedures to obtain sperm
- Communicating hydrosalpinges without a plan for surgical correct prior to frozen embryo transfer
- Endometrial Insufficiency, as defined by a prior cycle with maximal endometrial thickness \<6mm,), or persistent endometrial fluid
- Single gene disorders, chromosomal translocations, or any other disorders requiring a more detailed embryo genetic analysis
Exclusion
Key Trial Info
Start Date :
December 19 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
252 Patients enrolled
Trial Details
Trial ID
NCT06214936
Start Date
December 19 2023
End Date
June 1 2026
Last Update
February 7 2025
Active Locations (1)
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1
Reproductive Medicine Associates of New Jersey
Basking Ridge, New Jersey, United States, 07920