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This study aims to assess the effect of age of the male partner and the reproductive ability of sperm prepared via sperm selection devices (Zymot) compared to routine embryologist selected sperm after density gradient centrifugation (DGC) preparation for intracytoplasmic sperm injection (ICSI) in patients undergoing in vitro fertilization treatment (IVF) of their infertility.
In this study, we aim to determine the clinical utility of the Zymot sperm selection methodology for ICSI, while also accounting for paternal age. This study will be a prospective, split cohort, randomized, control trial comparing the routine standard of DGC sperm preparation for ICSI versus sperm prepared via Zymot for ICSI. Embryology parameters, ploidy status, DNA fragmentation and clinical pregnancy outcomes will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oocytes inseminated by sperm prepared by a microfluidic (Zymot) sperm preparation device | Experimental | Half of the mature oocytes will be randomly allocated to receive sperm prepared by the microfluidic (Zymot) sperm preparation device. This sperm will be used by the embryologist for the ICSI procedure. |
|
| Oocytes inseminated by sperm prepared via density grade centrifugation | Other | The other half of the mature oocytes will be allocated to receive sperm prepared by DGC. This sperm will be used by the embryologist for the ICSI procedure. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Microfluidic sperm separation device | Device | An aliquot of 850ul will be used for the Zymot sperm selection device. The sperm processing via Zymot will be per manufacturer's guidelines |
| 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:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Caroline Clinical Research Nurse, BSN, RN | Contact | 973-656-2841 | clinicalresearchteam@ivirma.com | |
| Christine Director of Research Operations, MS, BSN, RN | Contact | 973-656-2841 | clinicalresearchteam@ivirma.com |
| Name | Affiliation | Role |
|---|---|---|
| Kassie Bollig, MD, MSCE | Reproductive Medicine Associates of New Jersey | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reproductive Medicine Associates of New Jersey | Recruiting | Basking Ridge | New Jersey | 07920 | United States |
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Statistician
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| Density grade centrifugation | Other | 5ul of the ejaculated sample will be assessed for DGC via Makler assessment. If the sample for DGC is adequate per lab standard operating procedures, then routine DGC sperm preparation and embryologist sperm selection for the ICSI procedure will occur. |
|
| 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 |
| Ongoing pregnancy rate | rate of ongoing pregnancy at 8-9 weeks gestational age when discharged to obstetrician | 6 weeks post embryo transfer |
| Pregnancy Loss Rates | a loss of pregnancy (either biochemical or clinical) | 1 day to 7 months post positive beta human chorionic gonadotrophin |
| Live birth rate | rate of live born infants | approximately 7 months after discharge to obstetrician |
| Sperm DNA Fragmentation | Sperm DNA Fragmentation will be run on remnant samples | approximately 1-3 hours post intracytoplasmic sperm injection procedure |
| Positive beta human chorionic gonadotrophin (bhcg) | positive pregnancy test with bhcg >5mUI/mL | 7-10 days post embryo transfer |
| Embryological Efficiency | Sperm prep time (Time from embryologist possession of sample to completion of prep procedure and ICSI start), benchtop time, ICSI procedural time | same day as ICSI procedure |
| Embryology Questionnaire | Gain perspectives from lab personnel related to likeability, ease of use and efficiency between the two devices | upon primary outcome completion in approximately 18 months |
| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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