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| Name | Class |
|---|---|
| CooperSurgical Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oocytes allocated to the benchtop incubator | Other | Half of the mature oocytes and subsequent embryos will be cultured in the benchtop incubator |
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| Oocytes allocated to the box incubator | Other | Half of the mature oocytes and subsequent embryos will be cultured in the box incubator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Blastulation Rate per mature oocyte (M2) | count of blastocyst stage embryos per M2 count | approximately 1 week post oocyte retrieval procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Fertilization Rate | count of fertilized zygotes (2 pronuclei (2PN)) per M2 count | approximately 24 hours post oocyte retrieval procedure |
| Blastulation Rate per 2PN | count of blastocyst stage embryos per 2PN |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Molinaro, MD, MSCE | Reproductive Medicine Associates of New Jersey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reproductive Medicine Associates of New Jersey | Basking Ridge | New Jersey | 07920 | United States |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| 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 |
|
| approximately 1 week post oocyte retrieval procedure |
| Blastocyst Morphology using Modified Gardner Scale | Morphology Grade at time of trophectoderm biopsy and vitrification. Expansion 1-6. Inner cell mass and trophectoderm graded A-D. | approximately 1 week post oocyte retrieval procedure |
| Ploidy rates | Rates of whole chromosome negative and positive preimplantation genetic testing for aneuploidy (PGT-A) results per blastocyst | approximately 2 weeks post blastocyst trophectoderm biopsy |
| Sustained implantation rate (SIR) | rate of ongoing pregnancy at 8-9 weeks gestational age when discharged to obstetrician | 6 weeks post embryo transfer |
| Live birth rate | rate of live born infants | approximately 7 months after discharge to obstetrician |
| Embryologist Questionnaire | assess efficiency in the lab between the two incubators and other questions from the embryologist's perspectives | upon primary outcome completion in approximately 18 months |