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

Conditions

• Male Infertility, Azoospermia

Eligibility Criteria

Sex

ALL

Age

21 Years - 42 Years

Healthy Volunteers

Accepted

Interventions

• BAIBYS Sperm selection — DEVICE
  Software based decision support device for sperm selction based on morphology and motility
• Intra cytoplasmatic sperm injection — PROCEDURE
  Sperm injection into oocytes for ferilization
• Conventional manual sperm selection — PROCEDURE
  selection beased on motility at low magnification

Study Details

This study looks at an investigational automated, artificial intelligence (AI)-based sperm selection technology called the BAIBYS™ System. We want to see how it compares to current methods in terms of efficiency and effectiveness in producing high-quality Embryos, which can lead to successful pregnancies and healthy babies. Infertility impacts about 15% of couples globally, with male issues contributing to around 50% of these cases. You will be undergoing a treatment called Intra-Cytoplasmic Sperm Injection (ICSI) as part of your planned treatment program. In this procedure, embryologists inject selected sperm into an egg, based on its movement, observed under a low-magnification microscope. However, this method does not fully detect defects in sperm shape that may indicate sperm quality. Recent studies show that using high magnification for sperm selection is important for successful fertilization, higher embryo quality, lower birth defect rates, and higher birth rates of healthy babies. Selecting sperm manually under a microscope at high magnification takes a lot of time and depends on the skill of embryologists, which can lead to differences in judgment. Because of this, there is an interest in using AI to make sperm selection more accurate, consistent, and faster. The BAIBYS™ System uses advanced AI technology to automatically choose sperm based on their movement, size, and shape. These features help to determine the sperm's potential to be normal and produce a good embryo. The system also organizes the selected sperm into separate areas from which the embryologist will pick the sperm for injection into the egg. This investigational device could become a valuable tool in reproductive technology. Clinical research is crucial to confirm these ideas and show their long-term effects on fertility treatments. In this study, half of the oocytes retrieved during your IVF cycle will be injected with sperm selected from your partner's (or known donor's) semen by using the BAIBYS™ System, while the other half will be fertilized by sperm chosen according to the standard procedure at this institution. In any case, the embryologist will confirm that the sperm selected by the device are viable and acceptable. After fertilization, the best embryo, no matter which study group, will be selected for transfer to the uterus for pregnancy, and the rest of the good embryos will be frozen based on the institution's best standard clinical guidelines.

Key Dates

Start date

Mar 15, 2026

Status verified

Jan 2026

Primary completion

Aug 15, 2026

Completion

Oct 15, 2026

Study Design

Enrollment

260 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: BAIBYS+ICSI treatment arm
  Oocytes of this group will be fertilized with sperm selcted by the BAIBYS System
• Active Comparator: ICSI control arm
  Oocytes of this group will be fertilized with sperm selcted by conventional manual procedre

Primary Outcome Measure

Co-primary: Usable Blastocyte formation rate and Clinical Pregnancy rate [ Time Frame: 5-6 days post ICSI and 7 weeks post embryo transfer ]

Central Contacts

• David Rigler
  +972545850624
  [email protected]

Locations (1)

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