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

Launched by QART MEDICAL · Jan 30, 2024

Keywords

ClinConnect Summary

This clinical trial is testing a device called the Q300™ to see how well it helps in selecting sperm for a procedure known as ICSI (Intracytoplasmic Sperm Injection), which is often used in fertility treatments. The study is being conducted in a real-life setting within a reproductive lab, meaning that researchers want to understand how the device performs during actual patient care.

To participate, you need to be a patient at the hospital going through fertility treatments, either as a male or female. Eligible participants include males over 18 years old and females under 40 years old, who have fresh sperm and eggs available. If you meet these criteria and are interested, you can expect to be part of a study focused on improving sperm selection methods, which can ultimately enhance the chances of successful fertility treatments. It's also important to note that certain conditions, like having frozen sperm or specific types of fertility issues, may prevent you from joining the study.

Gender

ALL

Eligibility 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.