Validating Incubators in the Lab: Optimizing Culture and Investigating BlasTulation Yield
- Conditions
- Infertility
- Interventions
- Other: Benchtop IncubatorOther: Box Incubator
- Registration Number
- NCT06214936
- Lead Sponsor
- Reproductive Medicine Associates of New Jersey
- 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.
- 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 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 252
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Oocytes allocated to the benchtop incubator Benchtop Incubator Half of the mature oocytes and subsequent embryos will be cultured in the benchtop incubator Oocytes allocated to the box incubator Box Incubator Half of the mature oocytes and subsequent embryos will be cultured in the box incubator
- Primary Outcome Measures
Name Time Method Blastulation Rate per mature oocyte (M2) approximately 1 week post oocyte retrieval procedure count of blastocyst stage embryos per M2 count
- Secondary Outcome Measures
Name Time Method Fertilization Rate approximately 24 hours post oocyte retrieval procedure count of fertilized zygotes (2 pronuclei (2PN)) per M2 count
Blastulation Rate per 2PN approximately 1 week post oocyte retrieval procedure count of blastocyst stage embryos per 2PN
Blastocyst Morphology using Modified Gardner Scale approximately 1 week post oocyte retrieval procedure Morphology Grade at time of trophectoderm biopsy and vitrification. Expansion 1-6. Inner cell mass and trophectoderm graded A-D.
Ploidy rates approximately 2 weeks post blastocyst trophectoderm biopsy Rates of whole chromosome negative and positive preimplantation genetic testing for aneuploidy (PGT-A) results per blastocyst
Sustained implantation rate (SIR) 6 weeks post embryo transfer rate of ongoing pregnancy at 8-9 weeks gestational age when discharged to obstetrician
Live birth rate approximately 7 months after discharge to obstetrician rate of live born infants
Embryologist Questionnaire upon primary outcome completion in approximately 18 months assess efficiency in the lab between the two incubators and other questions from the embryologist's perspectives
Trial Locations
- Locations (1)
Reproductive Medicine Associates of New Jersey
🇺🇸Basking Ridge, New Jersey, United States