Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-25 @ 4:13 AM
NCT ID:
NCT06232720
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT06232720
Study Brief:
Protocol Section:
NCT06232720