A Sibling Oocyte Study- Comparison of ZyMotTM Microfluidics Device to Density Gradient for Sperm Selection During ICSI

NCT04818593 | Completed Results FDA Device

• 1 other identifier: 21-00021
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

ART

Keywords

ICSI

Outcome Measures

Primary Outcomes (1)

• Percentage of Good Quality Blastocyst Formation

  Good quality embryos will be defined as blastocyst stage embryos on day 5 or 6 of culture with an overall quality grade of good or fair. Embryo morphology assessment includes two parts: an Overall Grade and the Stage. Grading is a subjective assessment of the overall quality of the embryo as good, fair, or poor, and is based on assessment of certain characteristics of the embryo, such as fragmentation, symmetry, inner cell mass (ICM) quality and trophectoderm quality. The percentage will be reported for both arms (ZyMot compared to density gradient).

  Culture Day 5 or 6

Study Arms (2)

ZyMot Separation

EXPERIMENTAL

Treatment

Device: ZyMot Multi Sperm Separation Device (850 ul)

Density Gradient Centrifugation

ACTIVE COMPARATOR

Control

Other: Density Gradient Centrifugation

Interventions

ZyMot Multi Sperm Separation Device (850 ul) DEVICE

850 uL of untreated semen will be directly deposited into the inlet port of the ZyMotTM Multi device, followed by placement of 750 uL culture medium in the outlet port and throughout the upper collection chamber. The device will then be incubated in a humidified 37C CO2 incubator for 30 minutes. During incubation, the healthiest and most motile sperm will swim through the microporous filter and into the upper collection chamber, where they will be recovered via the outlet port. 500 uL of the sperm sample will be removed and placed in a separate tube for analysis and insemination.

ZyMot Separation

Density Gradient Centrifugation OTHER

Density gradient centrifugation will be performed using a one-layer preparation of 90% Isolate in 15 mL conical tubes. Semen will be layered over 1 mL of gradient and then centrifuged for 15 min at 300xg. The supernatant will be removed and discarded. The sperm pellet will be washed by mixing with Multipurpose Handling Medium Complete and centrifuging the sample for 5 min at 400xg. After the wash, the supernatant is removed and discarded and the pellet is re-suspended in culture medium, assessed for sperm parameters, and held at room temperature until insemination.

Density Gradient Centrifugation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• \. Anonymous donors

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Reproductive Specialists of NY

New York, New York, 10016, United States

Location

MeSH Terms

Interventions

Centrifugation, Density Gradient

Intervention Hierarchy (Ancestors)

Ultracentrifugation; Centrifugation; Investigative Techniques; Chemistry Techniques, Analytical

Results Point of Contact

• Title: Rani Fritz, DO, PhD, FACOG
• Organization: NYU Langone Health

rani.fritz@nyulangone.org

718-935-9766

Study Officials

• Rani Fritz, DO, PhD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2021
• First Posted: March 26, 2021
• Study Start: June 18, 2021
• Primary Completion: November 29, 2021
• Study Completion: November 29, 2021
• Last Updated: June 5, 2023
• Results First Posted: June 5, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research.
• Access Criteria: The investigator who proposed to use the data will have access to the data at the discretion of the PI. Requests should be directed to Rani.Fritz@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Locations

US (1)