Evaluating the Safety and Clinical Efficacy of the BAIBYS™ System in Intracytoplasmic Sperm Injection (ICSI)

The BAIBYS™ System is an automated microscopy-based tool intended to assist embryologists in selecting ideal spermatozoa based on morphological characteristics and motility for the Intra Cytoplasmic Sperm Injection (ICSI) procedure. It employs computer-vision machine learning algorithms trained with high-magnification live cell imagery. The system is indicated for adults who are undergoing the ICSI procedure.

Prospective, multi-center, two-arms (standard ICSI+BAIBYS™ vs. Standard ICSI only) randomized controlled study.

• The sperm selection methodology utilized in the BAIBYS™ System for ICSI serves as a software-based decision-support tool. The embryologist retains the final decision regarding the utilization of the sperm that has been chosen by the apparatus.
• The determination of the selected embryo for transferring to the uterine cavity and cryopreservation is based on the best conventional clinical practice. The study design directs only in cases of multiple decision options in order to maintain the balance between the sample size of the study cohorts.
• Each female participant will be equally randomized to either the BAIBYS™ arm or the Control arm. This randomization will determine the oocyte (extra) allocation, ICSI timing, and embryo transfer:

• The extra oocyte in case of an odd number will be assigned to the arm per the randomization plan
• The injection of spermatozoa from both arms will be administered as close as possible. Priority will be given according to the randomization plan.
• The embryo designated for transfer into the uterus will be selected based on the randomization plan in case the two best embryos from different arms exhibit similar quality assessment grading.
• The embryologists who inject sperm into the oocytes of both arms will remain blind to the study arm from which the sperm originated. The selected sperm in each arm will be transferred to a new ICSI dish in which the allocated oocytes are placed.

Inclusion criteria

• Couples intended to be ICSI recruited from the clinic's IVF units. Couples may be utilizing their own gametes, or gametes from one known donor (for donated gametes, the donor will also need to consent).
• Male subject aged ≥ 21 years at the time of screening
• Male subjects with at least 1 abnormal parameter at the sperm analysis according to the WHO criteria (count, motility, or morphology)
• Female subjects aged 21 to 42 years at the time of screening
• Number of follicles ≥14 mm as measured by ultrasound evaluation at ovulation trigger is at least 11
• The subject can provide a sperm sample by ejaculation. Sperm can be produced by electric ejaculation. Fresh or thawed sperm can be used for the procedure.
• Total Motile sperm Count (TMC) > 1 million
• The subject can understand and sign a written informed consent form

Exclusion criteria

• Severe grade IV endometriosis (suspected or confirmed by surgery), moderate to severe adenomyosis, or a condition that is known to render implantation unlikely, such as 3 or more prior losses related to uterine issues.
• Sperm produced by TESE (testicular sperm extraction)/TESA (testicular sperm aspiration).
• The subjects are under active oncology treatment.
• Participation in another study with any investigational drug or device that may conflict with the objectives, follow-up, or testing of this study.
• Planned sex selection or any other scenario where a less-optimal embryo is planned to be transferred
• Anonymous donor or other donor scenarios where it is uncertain whether freely given consent can be obtained