RECRUITING

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

Conditions

Infertility (IVF Patients)Oocyte Competence Sperm DNA Fragmentation Paternal Age Sperm Selection microfluidic density grade centrifugation Zymot

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-04-09

Study Completion:2026-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06629766

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 41 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Caroline Clinical Research Nurse, BSN, RN

CONTACT

973-656-2841

clinicalresearchteam@ivirma.com

Christine Director of Research Operations, MS, BSN, RN

CONTACT

973-656-2841

clinicalresearchteam@ivirma.com

Principal Investigator

Kassie Bollig, MD, MSCE

PRINCIPAL_INVESTIGATOR

Reproductive Medicine Associates of New Jersey

Study Locations (Sites)

Reproductive Medicine Associates of New Jersey

Basking Ridge, New Jersey, 07920

United States

Collaborators and Investigators

Sponsor: Reproductive Medicine Associates of New Jersey

Kassie Bollig, MD, MSCE, PRINCIPAL_INVESTIGATOR, Reproductive Medicine Associates of New Jersey

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-09

Study Completion Date2026-12

Study Record Updates

Study Start Date2025-04-09

Study Completion Date2026-12

Terms related to this study

Keywords Provided by Researchers

microfluidic
density grade centrifugation
sperm selection
paternal age
sperm DNA fragmentation
Zymot

Additional Relevant MeSH Terms

Infertility (IVF Patients)
Oocyte Competence
Sperm DNA Fragmentation
Paternal Age
Sperm Selection