to Aid in Sperm Selection for ICSINCT06232720
User Site Testing Study to Evaluate Usability of the Q300™ Device Under "Real-life Conditions" in a Reproductive Laboratory Environment Use
A study testing Q300 QART Medical in people with to Aid in Sperm Selection for ICSI, run by QART Medical at 1 site in Israel.
Trial summary
User Site Testing Study to evaluate usability of the Q300™ device under "real-life conditions" in a reproductive laboratory environment use. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- to Aid in Sperm Selection for ICSI
- What is being tested?
- Q300 QART Medical
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- 15 Feb 2024to 15 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Barzilay Medical Center
Ashkelon
Yulia Michaelov, Dr.
About this study
Official title: Q300 User Site Testing Study
User Site Testing Study to evaluate usability of the Q300™ device under "real-life conditions" in a reproductive laboratory environment use.
Read the 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
- Conditions
- to Aid in Sperm Selection for ICSI
- Being tested
- Q300 QART Medical
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Q300 QART MedicalDevice
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
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability
Usability surveys to users including user manual comprehensiveness questionnaire (evaluation of critical steps in the procedure, correct use, feedback on training provided).
Measured: 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.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2024
- Study start15 Feb 2024 (estimated)
- Primary completion31 Jan 2025 (estimated)
- Study completion15 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for to Aid in Sperm Selection for ICSIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The study will be an open label study, non-controlled and non-randomized.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- QART Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Orly Schwartz, Study director, QART Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06232720
- Sponsor's protocol ID
- Q300-02
- Status last verified
- Jan 2024
- First submitted
- 3 Jul 2023
- Last updated
- 31 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40495170Michailov 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.
PubMed 40124653
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Q300 User Site Testing Study
- ClinicalTrials.gov ID
- NCT06232720
- Acronym / sponsor ID
- Q300-02
- Conditions
- to Aid in Sperm Selection for ICSI
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- QART MedicalIndustry (pharma, biotech, devices)
- Study start
- 15 Feb 2024 (estimated)
- Primary completion
- 31 Jan 2025 (estimated)
- Study completion
- 15 Mar 2025 (estimated)
- First posted
- 31 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
User Site Testing Study to evaluate usability of the Q300™ device under "real-life conditions" in a reproductive laboratory environment use.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- The study will be an open label study, non-controlled and non-randomized.
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (8 listed)
- Frozen spermatozoa
- Immotile sperm
- Severe Oligozoospermia (less than 1 million sperm cells after preparation).
- Spermatozoa extracted by TESA/ TESE
- Frozen oocytes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Q300 QART MedicalThe 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 | Device | – |
Primary outcome
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).
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2024.
- Derived from this study: PubMed 40495170Michailov 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.
- Derived from this study: PubMed 40124653Michailov 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Orly Schwartz study director
QART Medical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Q300 QART Medical in people with to Aid in Sperm Selection for ICSI, run by QART Medical at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Orly Schwartz (0545936673, orlyschwartz@qart-medical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06232720, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2024.