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

NCT06214936 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 252

Last updated 2025-02-07

No results posted yet for this study

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.

Conditions

Interventions

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

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

Sponsors & Collaborators

  • CooperSurgical Inc.

    collaborator INDUSTRY

  • Reproductive Medicine Associates of New Jersey

    lead OTHER

Principal Investigators

  • Thomas Molinaro, MD, MSCE · Reproductive Medicine Associates of New Jersey

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
41 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-19
Primary Completion
2025-06-30
Completion
2026-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06214936 on ClinicalTrials.gov