The EPIC Study: Exploring Paternal Age and the Influence on Blastocyst Culture
Purpose
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.
Conditions
- Infertility (IVF Patients)
- Oocyte Competence
- Sperm DNA Fragmentation
- Paternal Age
- Sperm Selection
Eligibility
- Eligible Ages
- Between 18 Years and 41 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Undergoing first IVF cycle - 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
- Contraindication to IVF - 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Other
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Masking Description
- Statistician
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental 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. |
|
|
Other 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. |
|
Recruiting Locations
Reproductive Medicine Associates of New Jersey
Basking Ridge, New Jersey 07920
Basking Ridge, New Jersey 07920
More Details
- Status
- Recruiting
- Sponsor
- Reproductive Medicine Associates of New Jersey
Study Contact
Caroline Clinical Research Nurse, BSN, RN973-656-2841
clinicalresearchteam@ivirma.com
Detailed Description
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.