User Site Testing Study to Evaluate Usability of the Q300™ Device Under "Real-life Conditions" in a Reproductive Laboratory Environment Use

NCT06232720 | Unknown

• 1 other identifier: Q300-02
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

User Site Testing Study to evaluate usability of the Q300™ device under "real-life conditions" in a reproductive laboratory environment use.

Conditions

to Aid in Sperm Selection for ICSI

Outcome Measures

Primary Outcomes (2)

• Usability

  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

  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

Interventions

Q300 QART Medical DEVICE

The Q300TM Imaging system includes a Quantitative Phase Microscope. Q300TM uses a low intensity coherent light source, in a uniquely configured interferometer, which measures light delay as it passes different locations across the sperm cell. The amount

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• QART Medical: lead

Study Sites (1)

Barzilay Medical Center

Ashkelon, Israel

RECRUITING

Related Publications (2)

• Michailov Y, Amsalem E, Umanski N, Tamadaev V, Friedler S, Saar-Ryss B. Clinical outcome using the Q300 device in a reproductive laboratory environment: an open-label, non-controlled and non-randomized study. Reprod Biol Endocrinol. 2025 Jun 10;23(1):90. doi: 10.1186/s12958-025-01424-w.

  PMID: 40495170 DERIVED

• Michailov Y, Friedler S, Saar-Ryss B. First clinical pregnancy and delivery achieved after using a new 3D imaging technology for sperm selection: a case report. Front Reprod Health. 2025 Mar 7;7:1559684. doi: 10.3389/frph.2025.1559684. eCollection 2025.

  PMID: 40124653 DERIVED

Study Officials

• Orly Schwartz

  QART Medical

  STUDY DIRECTOR

Central Study Contacts

Orly Schwartz

CONTACT

0545936673; orlyschwartz@qart-medical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The study will be an open label study, non-controlled and non-randomized.

Study Record Dates

• First Submitted: July 3, 2023
• First Posted: January 31, 2024
• Study Start: February 15, 2024
• Primary Completion: January 31, 2025
• Study Completion: March 15, 2025
• Last Updated: January 31, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)