N/A
N=108
A Sibling Oocyte Study- Comparison of ZyMotTM Microfluidics Device to Density Gradient for Sperm Selection During ICSI
ART
Bottom Line
View on ClinicalTrials.gov: NCT04818593 ↗Enrolled (actual)
108
Serious AEs
0.0%
Results posted
Jun 2023
Primary outcome: Primary: Percentage of Good Quality Blastocyst Formation — 51.4; 51.7 percentage of embryos
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ZyMot Multi Sperm Separation Device (850 ul) (Device); Density Gradient Centrifugation (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Good Quality Blastocyst Formation |
51.4; 51.7 | — |
Summary
The primary objective of this study is to evaluate whether the percentage of good quality embryo formation following Intracytoplasmic Sperm Injection (ICSI) is improved with the use of ZyMot method of microfluidic sperm separation compared to density gradient.
Eligibility Criteria
Inclusion Criteria for Patients:
- Patient(s) over 18 years of age
- Patient(s) capable of providing informed consent
- Use or possible use of ICSI for oocyte insemination
- At least 6 mature oocytes at time of insemination via ICSI
Exclusion Criteria for Patients:
- Patient under 18 y/o
- Patients not capable of providing informed consent
- Use of IVF for insemination
- Less than 6 mature oocytes at time of rertrieval
- Anonymous donor sperm source
- Surgically retrieved sperm
- Sperm sample not sufficient for use with ZyMot device
Inclusion Criteria for Donors:
- Donor(s) over 18 years of age
- Donor(s) capable of providing informed consent
- Use of ejaculate sperm, fresh or frozen, for insemination
- Sufficient sperm for use of ZyMot
Exclusion Criteria for Donors:
- Anonymous donors
Data sourced from ClinicalTrials.gov (NCT04818593). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.