What this study is
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.
What's being tested
- Microfluidic sperm separation device
Intervention · DEVICE
An aliquot of 850ul will be used for the Zymot sperm selection device. The sperm processing via Zymot will be per manufacturer's guidelines
- Density grade centrifugation
Intervention · OTHER
5ul of the ejaculated sample will be assessed for DGC via Makler assessment. If the sample for DGC is adequate per lab standard operating procedures, then routine DGC sperm preparation and embryologist sperm selection for the ICSI procedure will occur.
Study details
- Sponsor
- Reproductive Medicine Associates of New Jersey
- Conditions
- Infertility (IVF Patients) · Oocyte Competence · Sperm DNA Fragmentation · Paternal Age · Sperm Selection
- Enrolling
- 100 people
- Starts
- 2025-04-09
- Est. completion
- 2028-12
- Design
- Quadruple-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years – 41 YearsSex FEMALEHealthy volunteers Not acceptedYou may qualify if
- 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
You 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 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openReproductive Medicine Associates of New Jersey
Basking Ridge, New Jersey, United States
Recruiting
Study team
Sponsor
Reproductive Medicine Associates of New Jersey
Study ID 2405-BRG-141-KB
Principal investigator
Kassie Bollig, MD, MSCE
Reproductive Medicine Associates of New Jersey
CONTACT
Christine Director of Research Operations, MS, BSN, RN
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.