BENCHMARK SPERM: A Prospective, Randomized Controlled Study Evaluating the Safety and Clinical Efficacy of the BAIBYS™ System in Intracytoplasmic Sperm Injection (ICSI)
Trial ID: NCT06990906
Status: NOT_YET_RECRUITING
Study type: INTERVENTIONAL
Phase: NA
Start date: 2026-03-15
Completion date: 2026-10-15
Sponsor: BAIBYS Fertility
Conditions: Male Infertility, Azoospermia
Interventions: BAIBYS Sperm selection; Intra cytoplasmatic sperm injection; Conventional manual sperm selection
Locations: New England Fertility Institute; Assuta Medical Center; Care Fertility Group
Countries: United States; Israel; United Kingdom
Enrollment: 260
Age range: 21 Years - 42 Years
Sex: ALL

Summary:
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.

Eligibility criteria:
Inclusion Criteria:

1. 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).
2. Male subject aged ≥ 21 years at the time of screening
3. Male subjects with at least 1 abnormal parameter at the sperm analysis according to the WHO criteria (count, motility, or morphology)
4. Female subjects aged 21 to 42 years at the time of screening
5. Number of follicles ≥14 mm as measured by ultrasound evaluation at ovulation trigger is at least 11
6. 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.
7. Total Motile sperm Count (TMC) \> 1 million
8. The subject can understand and sign a written informed consent form

Exclusion Criteria:

1. 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.
2. Sperm produced by TESE (testicular sperm extraction)/TESA (testicular sperm aspiration).
3. The subjects are under active oncology treatment.
4. Participation in another study with any investigational drug or device that may conflict with the objectives, follow-up, or testing of this study.
5. Planned sex selection or any other scenario where a less-optimal embryo is planned to be transferred
6. Anonymous donor or other donor scenarios where it is uncertain whether freely given consent can be obtained

Outcomes:
Co-primary: Usable Blastocyte formation rate and Clinical Pregnancy rate; Irreversible SADE