Clinical trial for Infertility (IVF Patients)
Official title The EPIC Study: Exploring Paternal Age and the Influence on Blastocyst Culture
ClinicalTrials.gov ID: NCT06629766
What this study is testing
- What it's testing
- The study wants to see whether using the Zymot device to pick sperm, compared with the usual lab method, changes outcomes, and how the male partner’s age influences those results.
- Who it's for
- Men and their partners who are undergoing in‑vitro fertilization with intracytoplasmic sperm injection.
- What's involved
- Sperm will be prepared either with the Zymot device or the standard density‑gradient method, then used for ICSI; participants will attend the usual IVF appointments and any extra study visits for sample collection and follow‑up.
- Time commitment
- The study follows one IVF cycle, requiring the normal IVF visits plus a few additional appointments during the cycle.
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 41, women only
You may be able to join if
- Undergoing first IVF cycle
- Electing single embryo transfer
- Electing PGT-A of their embryos
- Female partners age \ 18 years old.
- AMH ≥ 1.2 ng/mL
You likely can't join if
- Contraindication to IVF
- Clinical indication for preimplantation genetic testing (i.e., screening for single gene disorder, chromosomal translocation, or any other disorders...
- 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
See the full eligibility criteria
- Undergoing first IVF cycle
- Electing single embryo transfer
- Electing PGT-A of their embryos
- Female partners age \ 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
The study team makes the final eligibility decision.
Where it is enrolling
- Basking Ridge, New Jersey, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 41 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Basking Ridge, New Jersey, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.