The EPIC Study: Exploring Paternal Age and the Influence on Blastocyst Culture

Status: Recruiting
Location: See location...
Intervention Type: Device, Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 41
Healthy Volunteers: f
View:

• 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

Locations
United States
New Jersey
Reproductive Medicine Associates of New Jersey
RECRUITING
Basking Ridge
Contact Information
Primary
Caroline Clinical Research Nurse, BSN, RN
clinicalresearchteam@ivirma.com
973-656-2841
Backup
Christine Director of Research Operations, MS, BSN, RN
clinicalresearchteam@ivirma.com
973-656-2841
Time Frame
Start Date: 2025-04-09
Estimated Completion Date: 2026-12
Participants
Target number of participants: 100
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: Reproductive Medicine Associates of New Jersey

This content was sourced from clinicaltrials.gov