The EPIC Study: Exploring Paternal Age and the Influence on Blastocyst Culture
NCT ID: NCT06629766
Last Updated: 2025-04-17
Study Results
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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RECRUITING
NA
100 participants
INTERVENTIONAL
2025-04-09
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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Oocytes inseminated by sperm prepared by a microfluidic (Zymot) sperm preparation device
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.
Microfluidic sperm separation 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
Oocytes inseminated by sperm prepared via density grade centrifugation
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.
Density grade centrifugation
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.
Interventions
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Microfluidic sperm separation 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
Density grade centrifugation
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Electing single embryo transfer
* Electing PGT-A of their embryos
* Female partners age \<42 years old at start of VOR cycle, but \>18 years old.
* AMH ≥ 1.2 ng/mL
* AFC ≥ 8
* FSH ≤ 12IU/L
* At least 4 mature oocytes (M2s) retrieved at the VOR procedure in order to randomize
* Intention to transfer the morphological best quality, euploid, embryo at the frozen embryo transfer procedure
Exclusion Criteria
* Clinical indication for preimplantation genetic testing (i.e., screening for single gene disorder, chromosomal translocation, or any other disorders requiring a more detailed embryo genetic analysis)
* Male partner with azoospermia or oligozoospermia (\<500,000 total motile spermatozoa on the most recent semen analysis within one year of enrollment)
* Planned for previously cryopreserved sperm to be used for ICSI
* Donor sperm
* Male partner with Y-chromosome microdeletion
* Male partner with any Karyotype other than 46,XY
* Male partner requiring surgically obtained sperm either via testicular or epididymal retrieval procedures
* Uncorrected hydrosalpinges that communicate with the endometrial cavity
* Endometrial Insufficiency, as defined by a prior cycle with maximal endometrial thickness \<6mm,), or persistent endometrial fluid
* Donor oocyte or embryo cycles
* Gestational carriers
18 Years
41 Years
FEMALE
No
Sponsors
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Reproductive Medicine Associates of New Jersey
OTHER
Responsible Party
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Principal Investigators
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Kassie Bollig, MD, MSCE
Role: PRINCIPAL_INVESTIGATOR
Reproductive Medicine Associates of New Jersey
Locations
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Reproductive Medicine Associates of New Jersey
Basking Ridge, New Jersey, United States
Countries
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Central Contacts
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Other Identifiers
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2405-BRG-141-KB
Identifier Type: -
Identifier Source: org_study_id
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