NCT06629766 The EPIC Study: Exploring Paternal Age and the Influence on Blastocyst Culture
| NCT ID | NCT06629766 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Reproductive Medicine Associates of New Jersey |
| Condition | Infertility (IVF Patients) |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-04-09 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2025-04-09 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Kassie Bollig, MD, MSCE
PRINCIPAL INVESTIGATOR
Reproductive Medicine Associates of New Jersey
Frequently Asked Questions
Who can join the NCT06629766 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 41 Years, studying Infertility (IVF Patients). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06629766 currently recruiting?
Yes, NCT06629766 is actively recruiting participants. Contact the research team at clinicalresearchteam@ivirma.com for enrollment information.
Where is the NCT06629766 trial being conducted?
This trial is being conducted at Basking Ridge, United States.
Who is sponsoring the NCT06629766 clinical trial?
NCT06629766 is sponsored by Reproductive Medicine Associates of New Jersey. The principal investigator is Kassie Bollig, MD, MSCE at Reproductive Medicine Associates of New Jersey. The trial plans to enroll 100 participants.