Actively Recruiting
The EPIC Study: Exploring Paternal Age and the Influence on Blastocyst Culture
Led by Reproductive Medicine Associates of New Jersey · Updated on 2026-06-03
100
Participants Needed
1
Research Sites
100 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the impact of the male partner's age and the quality of sperm prepared using a specialized device called Zymot compared to the routine method of density gradient centrifugation (DGC) on outcomes in patients undergoing in vitro fertilization (IVF). This prospective, randomized, controlled trial focuses on intracytoplasmic sperm injection (ICSI) procedures and will assess embryology parameters, sperm DNA fragmentation, ploidy status, and clinical pregnancy results. In this study, mature oocytes from female participants will be randomly divided into two groups: one group fertilized with sperm prepared using the Zymot microfluidic sperm selection device, and the other with sperm prepared by the standard DGC method. Both sperm preparation methods are performed according to standard protocols, and the sperm will be used by embryologists for ICSI. The study will compare the fertilization and blastocyst development rates between these two sperm preparation techniques. Participants will undergo IVF treatment with at least four mature oocytes retrieved before randomization. Researchers will monitor outcomes such as blastulation rates about one week after oocyte retrieval, fertilization rates approximately 24 hours after retrieval, embryo morphology, pregnancy rates, pregnancy loss, and live birth rates. Additional assessments include sperm DNA fragmentation and embryological efficiency. Data collection extends through embryo transfer and up to live birth, with questionnaires completed about 18 months after the primary outcome.
CONDITIONS
Brief Title
The EPIC Study: Exploring Paternal Age and the Influence on Blastocyst Culture
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Undergoing first IVF cycle
- Electing single embryo transfer
- Electing preimplantation genetic testing for aneuploidy (PGT-A) of embryos
- Female partner aged between 18 and 41 years at start of the ovarian stimulation cycle
- Anti-Mullerian Hormone (AMH) level of at least 1.2 ng/mL
- Antral Follicle Count (AFC) of at least 8
- Follicle Stimulating Hormone (FSH) level of 12 IU/L or less
- At least 4 mature oocytes (M2) retrieved at ovarian stimulation procedure
- Intention to transfer the best morphological quality, euploid embryo at frozen embryo transfer procedure
You will not qualify if you...
- Contraindication to IVF treatment
- Need for preimplantation genetic testing for conditions other than PGT-A (e.g., single gene disorders, chromosomal translocations)
- Male partner with azoospermia or oligozoospermia (less than 500,000 total motile sperm in last semen analysis within one year)
- Planned use of previously cryopreserved sperm for ICSI
- Use of donor sperm
- Male partner with Y-chromosome microdeletion
- Male partner with any karyotype other than 46,XY
- Male partner requiring surgically retrieved sperm (testicular or epididymal)
- Uncorrected hydrosalpinges communicating with the uterine cavity
- Endometrial insufficiency defined by prior cycle with endometrial thickness less than 6 mm or persistent endometrial fluid
- Use of donor oocytes or embryos
- Use of gestational carriers
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 1 week
Participants undergo ovarian stimulation and oocyte retrieval. Half of the mature oocytes will be inseminated using sperm prepared by the microfluidic (Zymot) sperm preparation device, and the other half will be inseminated with sperm prepared by density gradient centrifugation (DGC) for the ICSI procedure.
1 oocyte retrieval procedure and ICSI procedure visit
Duration - Up to 7 months after embryo transfer
Participants are monitored for embryology outcomes, pregnancy status, and live birth outcomes following embryo transfer.
Several visits including approximately 7-10 days post embryo transfer, 6 weeks post embryo transfer, and follow-up visits up to 7 months
Trial Site Locations
Total: 1 location
1
Reproductive Medicine Associates of New Jersey
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
Research Team
C
Caroline Clinical Research Nurse, BSN, RN
C
Christine Director of Research Operations, MS, BSN, RN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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