Clinical trial NCT06629766: The EPIC Study: Exploring Paternal Age and the Influence on Blastocyst Culture
Official title: The EPIC Study: Exploring Paternal Age and the Influence on Blastocyst Culture
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Infertility (IVF Patients)
Oocyte Competence
Sperm DNA Fragmentation
Paternal Age
Sperm Selection
Keywords: microfluidic
density grade centrifugation
sperm selection
paternal age
sperm DNA fragmentation
Zymot
Lead sponsor: Reproductive Medicine Associates of New Jersey
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 41
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

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

Primary outcomes:
measure: Blastulation Rate per Mature Oocyte (M2)
timeFrame: approximately 1 week post oocyte retrieval procedure
Secondary outcomes:
measure: Fertilization Rate
timeFrame: approximately 24 hours post oocyte retrieval procedure
measure: Blastulation Rate per 2PN
timeFrame: approximately 1 week post oocyte retrieval procedure
measure: Blastocyst Morphology using Modified Gardner Scale
timeFrame: approximately 1 week post oocyte retrieval procedure
measure: Ploidy rates
timeFrame: approximately 2 weeks post blastocyst trophectoderm biopsy
measure: Ongoing pregnancy rate
timeFrame: 6 weeks post embryo transfer
measure: Pregnancy Loss Rates
timeFrame: 1 day to 7 months post positive beta human chorionic gonadotrophin
measure: Live birth rate
timeFrame: approximately 7 months after discharge to obstetrician
measure: Sperm DNA Fragmentation
timeFrame: approximately 1-3 hours post intracytoplasmic sperm injection procedure
measure: Positive beta human chorionic gonadotrophin (bhcg)
timeFrame: 7-10 days post embryo transfer
measure: Embryological Efficiency
timeFrame: same day as ICSI procedure
measure: Embryology Questionnaire
timeFrame: upon primary outcome completion in approximately 18 months
Other outcomes:
Locations:
city: Basking Ridge
country: United States
facility: Reproductive Medicine Associates of New Jersey
state: New Jersey
Study officials:
affiliation: Reproductive Medicine Associates of New Jersey
name: Kassie Bollig, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References: