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The purpose of the study is to determine if a dynamic embryo microenvironment impacts embryo development and reproductive potential in comparison to static culture.
The proposed research design is a prospective randomized control trial. Patients with normal ovarian reserve, who would be expected to have reasonable outcomes after in vitro fertilization, will serve as the subjects. Embryos from the same patient will be randomized to either static or dynamic culture. They will then be cultured to the blastocyst stage of embryo development and biopsied for preimplantation genetic screening. The best chromosomally normal embryo from each culture group will be selected and transferred to complete a double embryo transfer in a subsequent frozen embryo transfer cycle the following month.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dynamic Culture Platform | Experimental | Embryos randomized to the dynamic arm will be placed on the NSSB-300 microvibration platform within the designated incubator. The platform will vibrate at a strength setting of 4 for 5 seconds every 60 minutes. The embryos will be placed on the platform at the two pronucleur stage of development and remain on the platform until the blastocyst stage of development at which time the embryos will be biopsied for preimplantation genetic screening and frozen. |
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| Static Culture | No Intervention | The embryos randomized to the static or control arm of the study will be placed directly into the incubator and will not have any additional vibration, per routine care. The embryos will be placed in the incubator at the two pronucleur stage of development and remain in the incubator until the blastocyst stage of development at which time the embryos will be biopsied for preimplantation genetic screening and frozen. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dynamic culture platform | Other | Patients will have their cohort of embryos split in half. Half will be cultured in the dynamic platform and the other half cultured in static. |
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| Measure | Description | Time Frame |
|---|---|---|
| Blastulation Rate | the number of blastocysts will be counted | 6 days post vaginal oocyte retrieval procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical Pregnancy Rate | documented intrauterine pregnancy | approximately 20-25 days post embryo transfer procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard T Scott, MD, HCLD | 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32044089 | Derived | Juneau CR, Tiegs AW, Franasiak JM, Goodman LR, Whitehead C, Patounakis G, Scott RT Jr. Embryo's Natural Motion (enMotion): a paired randomized controlled trial evaluating a dynamic embryo culture system. Fertil Steril. 2020 Mar;113(3):578-586.e1. doi: 10.1016/j.fertnstert.2019.09.043. Epub 2020 Feb 7. |
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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