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

NCT06214936 | Recruiting

• 1 other identifier: 2206-BRG-075-CW
• Study Type: interventional
• Target: 252
• Locations: 1 country
• Sites: 1

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 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

Infertility

Outcome Measures

Primary Outcomes (1)

• Blastulation Rate per mature oocyte (M2)

  count of blastocyst stage embryos per M2 count

  approximately 1 week post oocyte retrieval procedure

Secondary Outcomes (7)

• Fertilization Rate

  approximately 24 hours post oocyte retrieval procedure

• Blastulation Rate per 2PN

  approximately 1 week post oocyte retrieval procedure

• Blastocyst Morphology using Modified Gardner Scale

  approximately 1 week post oocyte retrieval procedure

• Ploidy rates

  approximately 2 weeks post blastocyst trophectoderm biopsy

• Sustained implantation rate (SIR)

  6 weeks post embryo transfer

Study Arms (2)

Oocytes allocated to the benchtop incubator

OTHER

Half of the mature oocytes and subsequent embryos will be cultured in the benchtop incubator

Other: Benchtop Incubator

Oocytes allocated to the box incubator

OTHER

Half of the mature oocytes and subsequent embryos will be cultured in the box incubator

Other: Box Incubator

Interventions

Benchtop Incubator OTHER

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

Oocytes allocated to the benchtop incubator

Box Incubator OTHER

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

Oocytes allocated to the box incubator

Eligibility Criteria

• Age: 18 Years - 41 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients undergoing an IVF cycle with plan for subsequent frozen embryo transfer (FET) of a single euploid embryo
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Reproductive Medicine Associates of New Jersey: lead
• CooperSurgical Inc.: collaborator

Study Sites (1)

Reproductive Medicine Associates of New Jersey

Basking Ridge, New Jersey, 07920, United States

RECRUITING

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Study Officials

• Thomas Molinaro, MD, MSCE

  Reproductive Medicine Associates of New Jersey

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caroline Zuckerman, BS, RN

CONTACT

19736562841; clinicalresearchteam@ivirma.com

Christine V Whitehead, BSN, RN

CONTACT

19736562841; clinicalresearchteam@ivirma.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2023
• First Posted: January 22, 2024
• Study Start: December 19, 2023
• Primary Completion: June 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 7, 2025

Record last verified: 2025-02

Locations

US (1)