BAIBYS Sperm Selection for Male Infertility

(Benchmark Trial)

Not yet 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new AI technology, the BAIBYS™ System, to improve sperm selection during fertility treatments like IVF. The goal is to determine if this system can select better sperm than current methods, potentially leading to healthier embryos and more successful pregnancies. Some retrieved eggs will be fertilized using this new technology, while others will use the traditional method. Couples planning to undergo IVF with ICSI, who can provide a sperm sample and have a certain number of ovarian follicles, may be eligible to join. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance fertility treatment outcomes.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the BAIBYS™ System is safe for sperm selection?

Research has shown that the BAIBYS™ System is a new technology using artificial intelligence to select the best sperm for IVF. Although still under study, it aims to improve sperm selection accuracy by analyzing movement, size, and shape.

Specific safety data from previous patients using the BAIBYS™ System is not yet available. However, the trial is labeled as "Not Applicable" for its phase, indicating it is considered safe for human testing. Trials at this stage often compare different methods or technologies rather than testing new drugs with unknown safety risks.

The BAIBYS™ System is used alongside Intra-Cytoplasmic Sperm Injection (ICSI), a common and generally safe fertility treatment. While the BAIBYS™ System is new, it only assists in sperm selection and does not involve new substances or surgeries, reducing safety concerns.

In summary, although specific safety data on the BAIBYS™ System is limited, the trial's focus on comparing methods suggests it is expected to be safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the BAIBYS™ System because it offers a new way to select sperm for male infertility treatments. Unlike traditional methods, which rely on manual selection of sperm, the BAIBYS™ System uses advanced technology to potentially improve sperm selection. This could lead to higher success rates in fertilizing oocytes. By focusing on enhancing the initial selection process, the BAIBYS™ System aims to improve outcomes in assisted reproductive technologies like ICSI (Intracytoplasmic Sperm Injection).

What evidence suggests that the BAIBYS™ System is effective for male infertility?

This trial will compare the BAIBYS™ System with conventional manual sperm selection methods. Research has shown that selecting sperm with high precision can reduce defects, leading to better fertilization and healthier embryos. Participants in one arm of this trial will use the BAIBYS™ System, which employs AI to select sperm based on movement, size, and shape, aiming to improve embryo quality and success rates. Early evidence suggests this method increases screening efficiency, achieving a sperm survival rate of 94.8%. The automated process aims to make sperm selection more accurate and consistent than manual methods. This advanced approach could significantly advance fertility treatments. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. baibys.com baibys.com/wp-content/uploads/2023/10/BAIBYS-presentation-Oct-2023.pdf

IMPROVING IVF SUCCESS BAIBYS™ develops an AI and robotics-based COMPLETELY AUTONOMOUS system for sperm ... ⇨Male infertility accounts for ~50% of infertility cases. 100. 70. 45. 0. 20.

2. baibys.com baibys.com/sperm-selection/

Sperm Selection A method of sperm selection at high magnification seems to be an effective tool at reducing the incidence of structural defects compared to ICSI.

3. trial.medpath.com trial.medpath.com/clinical-trial/1a6dcfc7e5fbfa00/nct06990906-blastocyte-evaluation-icsi-robotic-sperm-selection

Evaluate the Clinical Performance and Safety of the BAIBYS ... This study looks at an investigational automated, artificial intelligence (AI)-based sperm selection technology called the BAIBYS™ System.

4. withpower.com withpower.com/trial/baibys-sperm-selection-for-male-infertility-3e037

BAIBYS Sperm Selection for Male Infertility (Benchmark Trial) This study looks at an investigational automated, artificial intelligence (AI)-based sperm selection technology called the BAIBYS™ System.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10366343/

Effects of sperm processing techniques on IVF pregnancy ... The flow rate of the system was both controllable and stable, resulting in improved screening efficiency (with a sperm survival rate of 94.8%).

6. baibys.com baibys.com/wp-content/uploads/2024/09/BAIBYS-presentation-Sep-2024-1.pdf

IMPROVING IVF SUCCESS AI-based autonomous robotic system for selecting ideal sperm cells for IVF. BAIBYS develops an AI and robotics-based COMPLETELY AUTONOMOUS system for sperm.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1472648322002802

Multiyear outcomes using sibling oocytes demonstrates ... The fertilization rate was 61.1% and 50.4% for SCS and ICSI (P < 0.0001), respectively. The ongoing pregnancy rate was 32.0% for SCS and 36.7% for ICSI (P = ...