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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

252 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-19

Study Completion Date

2026-06-30

Brief Summary

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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.

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Detailed Description

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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 incubator. Following enrollment, participants will undergo ovarian stimulation and oocyte retrieval per routine as previously consented to at the clinic. IVF stimulation protocol will be at the discretion of the participant's individual provider, per routine. Those participants that develop 4 or more mature oocytes will proceed with randomization. Intracytoplasmic Sperm Injection (ICSI) will be performed, as well as assisted hatching on day 3 and embryos will be cultured to the blastocyst stage per routine. It is important to note that there are no changes to the routine embryology care itself, the only difference within the study is that the participant's cohort of oocytes will be split into two groups and randomized to placement within each type of incubator (benchtop and conventional box incubator). The participant, physician, and the clinical team will all be blinded to the randomization of the oocytes and subsequent embryos until study completion. All embryologists making any assessments or selecting the embryo for transfer will also be blinded.

Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Oocytes allocated to the benchtop incubator

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

Group Type OTHER

Benchtop Incubator

Intervention Type 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 box incubator

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

Group Type OTHER

Box Incubator

Intervention Type 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

Interventions

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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

Intervention Type 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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Patients undergoing an IVF cycle with plan for subsequent frozen embryo transfer (FET) of a single euploid embryo
2. 4 mature oocytes prior to randomization
3. Female partners age \<42 years old at start of their vaginal oocyte retrieval (VOR) cycle
4. Normal ovarian reserve:

1. Antimullerian Hormone Level (AMH) ≥ 1.2 ng/mL
2. Antral Follicle Count (AFC) ≥ 8
3. Follicle Stimulating Hormone (FSH) FSH ≤ 12international units (IU)/L
5. Body Mass Index (BMI) \<35
6. 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

1. All patients who do not voluntarily give their written consent for participation
2. Patients with a prior failed IVF cycle - defined as no blastocysts
3. Patients with a history of more than one failed euploid embryo transfer
4. Donor oocyte cycles
5. Gestational Carriers
6. Male partner with \<100,000 total motile spermatozoa per ejaculate (donor sperm is acceptable)
7. Use of surgical procedures to obtain sperm
8. Communicating hydrosalpinges without a plan for surgical correct prior to frozen embryo transfer
9. Endometrial Insufficiency, as defined by a prior cycle with maximal endometrial thickness \<6mm,), or persistent endometrial fluid
10. Single gene disorders, chromosomal translocations, or any other disorders requiring a more detailed embryo genetic analysis

Minimum Eligible Age

18 Years

Maximum Eligible Age

41 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No