Exploring how paternal age affects sperm selection in IVF
The EPIC Study: Exploring Paternal Age and the Influence on Blastocyst Culture
NA · Reproductive Medicine Associates of New Jersey · NCT06629766
This study tests if using a new sperm selection device helps men of different ages have better success with IVF compared to the traditional method.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 41 Years |
| Sex | Female |
| Sponsor | Reproductive Medicine Associates of New Jersey (other) |
| Locations | 1 site (Basking Ridge, New Jersey) |
| Trial ID | NCT06629766 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of paternal age on sperm quality and reproductive success in patients undergoing in vitro fertilization (IVF). It compares the effectiveness of a microfluidic sperm selection device (Zymot) against the traditional density gradient centrifugation method for preparing sperm for intracytoplasmic sperm injection (ICSI). The study will assess various embryology parameters, including DNA fragmentation and clinical pregnancy outcomes, in a randomized control trial format. Participants will be monitored throughout their IVF cycle to evaluate the outcomes of using different sperm preparation techniques.
Who should consider this trial
Good fit: Ideal candidates are couples undergoing their first IVF cycle with specific criteria regarding female age, ovarian reserve, and embryo quality.
Not a fit: Patients with male partners who have azoospermia, oligozoospermia, or other significant sperm quality issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance IVF success rates by optimizing sperm selection methods based on paternal age.
How similar studies have performed: While there have been studies on sperm selection methods, this specific approach considering paternal age is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Basking Ridge, New Jersey
- Reproductive Medicine Associates of New Jersey — Basking Ridge, New Jersey, United States (RECRUITING)
Study contacts
- Principal investigator: Kassie Bollig, MD, MSCE — Reproductive Medicine Associates of New Jersey
- Study coordinator: Caroline Clinical Research Nurse, BSN, RN
- Email: clinicalresearchteam@ivirma.com
- Phone: 973-656-2841
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Infertility, Oocyte Competence, Sperm DNA Fragmentation, Paternal Age, Sperm Selection, microfluidic, density grade centrifugation, sperm selection