Evaluating the Q300 device for sperm selection in IVF labs
Q300 User Site Testing Study
NA · QART Medical · NCT06232720
This study is testing a new device called the Q300 to see if it can help fertility experts choose better sperm for IVF treatments.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | QART Medical (industry) |
| Locations | 1 site (Ashkelon) |
| Trial ID | NCT06232720 on ClinicalTrials.gov |
What this trial studies
This study evaluates the usability of the Q300™ device in real-life reproductive laboratory conditions, focusing on its effectiveness in aiding sperm selection for intracytoplasmic sperm injection (ICSI). The study aims to confirm the adequacy of the User Manual, improve the device based on user feedback, and assess the impact of the Q300™ on embryologists' ability to select morphologically-compliant sperm cells. Additionally, it seeks to refine the QART Feature Extraction algorithm and evaluate the clinical outcomes associated with its use.
Who should consider this trial
Good fit: Ideal candidates include males over 18 and females under 40 who are undergoing ICSI with fresh oocytes and motile sperm.
Not a fit: Patients using frozen sperm or those with severe male factor infertility may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the sperm selection process in IVF, potentially improving pregnancy rates.
How similar studies have performed: While similar usability evaluations have been conducted, the specific application of the Q300™ device in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Ashkelon
- Barzilay Medical Center — Ashkelon, Israel (RECRUITING)
Study contacts
- Study coordinator: Orly Schwartz
- Email: orlyschwartz@qart-medical.com
- Phone: 0545936673
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: to Aid in Sperm Selection for ICSI