Q300 QART Medical in to Aid in Sperm Selection for ICSI - Clinical Trials Registry

Study Overview

Status

Recruiting

Conditions

to Aid in Sperm Selection for ICSI

Intervention / Treatment

Device: Q300 QART Medical

Detailed Description

Testing the Usability of the Q300™ device.

Specific objectives of this evaluation are as follows:

Confirm the comprehensiveness of the User Manual in providing adequate instructions for proper system operation and application.
Assist in further improving the User Manual and generate input to Manufacturer on way to improve the Q300™ device.
Demonstrate that Q300 can be used by the intended users without use errors or problems that negatively impact system use.
Evaluate the effect of using the Q300™ on the user's (i.e. embryologist's) ability to prospectively select morphologically-compliant sperm cells.
Assist in determining the inclusion/exclusion criteria for subsequent clinical investigations.
Further improve the QART Feature Extraction algorithm observing general morphological phenotypes in sperm cells.
Evaluate effect of using the Q300 on the clinical outcome

Study Type

Interventional

Enrollment (Estimated)

40

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Orly Schwartz
Phone Number: 0545936673
Email: orlyschwartz@qart-medical.com

Study Locations

Israel
- - Ashkelon, Israel
    - Recruiting
    - Barzilay Medical Center
    - Contact:
      
      Yulia Michaelov, Dr.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Patient intended for ICSI recruited from the hospital's IVF (both male and female are considered patients in this study).
Male, Age >18 yrs
Female age < 40 yrs
Patients signed informed consent prior study procedures.
Fresh Oocytes
Fresh ejaculated motile sperm and presence of motile sperm at the time of sperm selection for ICSI
Fresh oocytes
Non severe male factor (TMC>1*10^6/mL)
Unexplained factor infertility
AFC >=13mm during ovarian stimulation prior to ovulation trigger or induction#>=5 in the cycle

Exclusion Criteria:

Frozen spermatozoa
Immotile sperm
Severe Oligozoospermia (less than 1 million sperm cells after preparation).
Spermatozoa extracted by TESA/ TESE
Frozen oocytes
Egg or ovulatory female factor such as low ovarian reserve (menstrual cycle, per AFC. AMH test- if performed) or non-typical eggs or eggs with severe pathology (qualitative; please find
That the instructions for use of Q300TM have not been fully followed (poor quality of images etc…)
Inability to reliably trace sperm-oocyte-embryo clinical outcome throughout the process.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability Time Frame: 1 year	Usability surveys to users including user manual comprehensiveness questionnaire (evaluation of critical steps in the procedure, correct use, feedback on training provided).	1 year
Usable blastocyst formation rate Time Frame: 5 days	Number of usable (transferred or frozen) embryos per cycle (Gardner 2BB at day 5 or equivalent or grade "good" according to Istanbul consensus for cleavage-stage.	5 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

QART Medical

Investigators

Study Director: Orly Schwartz, QART Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

February 15, 2024

Primary Completion (Estimated)

January 31, 2025

Study Completion (Estimated)

March 15, 2025

Study Registration Dates

First Submitted

July 3, 2023

First Submitted That Met QC Criteria

January 30, 2024

First Posted (Estimated)

January 31, 2024

Study Record Updates

Last Update Posted (Estimated)