Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-25 @ 4:13 AM
NCT ID:
NCT06232720
Brief Summary:
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:
NCT06232720
Study Brief:
Protocol Section:
NCT06232720