Recruiting

Observational Study

Sponsor:

Reproductive Medicine Associates of New Jersey

Code:

NCT06629766

Conditions

Infertility (IVF Patients)

Oocyte Competence

Sperm DNA Fragmentation

Paternal Age

Sperm Selection

Eligibility Criteria

Sex: Female

Age: 18 - 41

Healthy Volunteers: Not accepted

Interventions

Microfluidic sperm separation device

Density grade centrifugation

Study Details

Brief summary:

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.

Conditions

Infertility (IVF Patients)

Oocyte Competence

Sperm DNA Fragmentation

Paternal Age

Sperm Selection

Study ID

NCT06629766

Start date

Apr 9, 2025

Status verified date

Jun, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Jan, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 41

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Oocytes inseminated by sperm prepared by a microfluidic (Zymot) sperm preparation device

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.

other: Oocytes inseminated by sperm prepared via density grade centrifugation

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.

Interventions

Microfluidic sperm separation 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

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.

Primary outcome measure

  • Blastulation Rate per Mature Oocyte (M2) [ Time Frame: approximately 1 week post oocyte retrieval procedure ]

Central Contacts and Locations

Central contacts

Caroline Clinical Research Nurse, BSN, RN

973-656-2841clinicalresearchteam@ivirma.com

Christine Director of Research Operations, MS, BSN, RN

973-656-2841clinicalresearchteam@ivirma.com

Locations

Reproductive Medicine Associates of New Jersey

Recruiting

Basking Ridge, New Jersey, United States, 07920

More Information

Sponsor

Reproductive Medicine Associates of New Jersey

Last update posted

Jun 3, 2026

Last verified

Jun, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Reproductive Medicine Associates of New Jersey on 2026-06-03.