Exploring how paternal age affects sperm selection in IVF

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.