BAIBYS Sperm Selection for Male Infertility

(Benchmark Trial)

Recruiting at 2 trial locations

Overseen By David Rigler

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: BAIBYS Fertility

Disqualifiers: Severe endometriosis, Adenomyosis, Oncology treatment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

150 Participants Needed

Trial Summary

What is the purpose of this trial?

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

This trial is for men experiencing infertility, including those with a diagnosis of azoospermia. Participants will already be undergoing Intra-Cytoplasmic Sperm Injection (ICSI) as part of their treatment plan. The study excludes individuals who do not meet the specific requirements set by the researchers.

Inclusion Criteria

Couples intended for ICSI recruited from the clinic's IVF units using own gametes or gametes from one known donor (donor consent required)

Number of follicles ≥13 mm as measured by ultrasound evaluation at ovulation trigger is at least 11

Total Motile sperm Count (TMC) > 1 million

Exclusion Criteria

Frozen/thawed oocytes

Participation in another study with investigational drug or device that may conflict with this study

Planned sex selection or scenarios where a less-optimal embryo is planned to be transferred

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

ICSI Procedure

Participants undergo the ICSI procedure using either the BAIBYS™ System or standard manual sperm selection

1 day

1 visit (in-person)

Embryo Transfer

The best embryo is selected and transferred to the uterus for potential pregnancy

1 day

1 visit (in-person)

Follow-up

Participants are monitored for pregnancy outcomes and device safety

6-8 weeks

2 visits (in-person)

Treatment Details

Interventions

• BAIBYS™ System

Trial Overview The BAIBYS™ System, an AI-based technology for selecting sperm, is being tested against conventional manual selection methods during ICSI procedures. The goal is to assess if this system can improve embryo quality and increase the chances of successful pregnancies.

Participant Groups

Group I: BAIBYS+ICSI treatment arm Experimental Treatment 3 Interventions

Oocytes of this group will be fertilized with sperm selcted by the BAIBYS System

Group II: ICSI control arm Active Control 2 Interventions

Oocytes of this group will be fertilized with sperm selcted by conventional manual procedre

Who Is Running the Clinical Trial?

BAIBYS Fertility

Lead Sponsor

Trials

1

Recruited

40+