An interventional study of Microfluidic sperm separation device and Density grade centrifugation in Infertility (IVF Patients), Oocyte Competence and Sperm DNA Fragmentation, sponsored by Reproductive Medicine Associates of New Jersey. Recruiting at 1 site in United States. Open to female participants aged 18 Years to 41 Years. Per ClinicalTrials.gov, last updated 2026-06-03.
Sponsored by Reproductive Medicine Associates of New Jersey · Not applicable, Interventional, and Other
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.
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.
2,085 studies on the registry are indexed under Infertility; 357 are open to participants now.
This study's planned enrollment of 100 is below the median of 135 across 1,412 interventional studies indexed under Infertility.
Browse Infertility studies →Reproductive Medicine Associates of New Jersey is the lead sponsor of 55 studies on the registry; 8 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Half of the mature oocytes will be randomly allocated to receive sperm prepared by the microfluidic (Zymot) sperm preparation device. This sperm will be used by the embryologist for the ICSI procedure.
Device: Microfluidic sperm separation device
The other half of the mature oocytes will be allocated to receive sperm prepared by DGC. This sperm will be used by the embryologist for the ICSI procedure.
Other: Density grade centrifugation
An aliquot of 850ul will be used for the Zymot sperm selection device. The sperm processing via Zymot will be per manufacturer's guidelines
Also known as: Zymot
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.
Blastulation Rate per Mature Oocyte (M2)
count of blastocyst stage embryos per M2 count
Time frame: approximately 1 week post oocyte retrieval procedure
Fertilization Rate
count of fertilized zygotes (2 pronuclei (2PN)) per M2 count
Time frame: approximately 24 hours post oocyte retrieval procedure
Blastulation Rate per 2PN
count of blastocyst stage embryos per 2PN
Time frame: approximately 1 week post oocyte retrieval procedure
Blastocyst Morphology using Modified Gardner Scale
Morphology Grade at time of trophectoderm biopsy and vitrification. Expansion 1-6. Inner cell mass and trophectoderm graded A-D.
Time frame: approximately 1 week post oocyte retrieval procedure
Ploidy rates
Rates of whole chromosome negative and positive preimplantation genetic testing for aneuploidy (PGT-A) results per blastocyst
Time frame: approximately 2 weeks post blastocyst trophectoderm biopsy
Ongoing pregnancy rate
rate of ongoing pregnancy at 8-9 weeks gestational age when discharged to obstetrician
Time frame: 6 weeks post embryo transfer
Pregnancy Loss Rates
a loss of pregnancy (either biochemical or clinical)
Time frame: 1 day to 7 months post positive beta human chorionic gonadotrophin
Live birth rate
rate of live born infants
Time frame: approximately 7 months after discharge to obstetrician
Sperm DNA Fragmentation
Sperm DNA Fragmentation will be run on remnant samples
Time frame: approximately 1-3 hours post intracytoplasmic sperm injection procedure
Positive beta human chorionic gonadotrophin (bhcg)
positive pregnancy test with bhcg \>5mUI/mL
Time frame: 7-10 days post embryo transfer
Embryological Efficiency
Sperm prep time (Time from embryologist possession of sample to completion of prep procedure and ICSI start), benchtop time, ICSI procedural time
Time frame: same day as ICSI procedure
Embryology Questionnaire
Gain perspectives from lab personnel related to likeability, ease of use and efficiency between the two devices
Time frame: upon primary outcome completion in approximately 18 months
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2025 (actual). Primary completion is estimated for Jan 2027, 21 months after the start.
Of 385 non-industry interventional studies with no phase under Infertility, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 46. This study's planned 21 months is below that.
Counting every sponsor, half of 416 studies reached it within 24 months; a quarter within 10 and three quarters within 43.
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Reproductive Medicine Associates of New Jersey