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

NCT06990906 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: CLN-009
• Study Type: interventional
• Target: 260
• Locations: 3 countries
• Sites: 3

Brief 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.

Conditions

Male Infertility, Azoospermia

Keywords

ICSI; ART; Oocyte; Spermatozoa; Blastocyst

Outcome Measures

Primary Outcomes (2)

• Co-primary: Usable Blastocyte formation rate and Clinical Pregnancy rate

  A co-primary clinical performance endpoint. 1. Usable Blastocyst Rate Using Gardner's scoring, a superiority margin of 5% between the BAIBYS™ treatment arm and the standard ICSI arm of usable blastocyst development rate (≥3BB) at day 5 or 6 post-insemination (Embryos that do not reach the blastocyst stage by day 5 but continue to develop into morulae or blastocysts shall be followed and reassessed on day 6). 2. Clinical Pregnancy Rate A superiority margin of 1% between the BAIBYS™ treatment arm and the standard ICSI arm of the proportion of embryo transfers resulting in a clinical pregnancy confirmed at week 7±1 by ultrasound visualization of an intrauterine gestational sac with fetal heartbeat

  5-6 days post ICSI and 7 weeks post embryo transfer

• Irreversible SADE

  The incidence of irreversible Serious Adverse Device (SADE) in the BAIBYS™ treated arm group is ≤ 5%. Incidence encompasses deficiencies associated with the device, including user error, device malfunction, or suboptimal performance resulting in the incapacity to effectively and safely execute the ICSI procedure

  1-day post-ICSI

Secondary Outcomes (3)

• Procedure Efficiency

  ICSI day 0

• Pregnancy rate

  6-8 weeks post embryo transfer

• Fertilization rate

  16-18 hours post-ICSI

Other Outcomes (3)

• Blastocyte formation rate as a function of 2PN zygote

  5-6 days post ICSI

• Implantation rate

  1 day post embryo transfer

• Biochemistry pregnancy rate

  12 to 14 post-embryo transfer

Study Arms (2)

BAIBYS+ICSI treatment arm

EXPERIMENTAL

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

Device: BAIBYS Sperm selection; Procedure: Intra cytoplasmatic sperm injection; Procedure: Conventional manual sperm selection

ICSI control arm

ACTIVE COMPARATOR

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

Procedure: Intra cytoplasmatic sperm injection; Procedure: Conventional manual sperm selection

Interventions

BAIBYS Sperm selection DEVICE

Software based decision support device for sperm selction based on morphology and motility

BAIBYS+ICSI treatment arm

Intra cytoplasmatic sperm injection PROCEDURE

Sperm injection into oocytes for ferilization

BAIBYS+ICSI treatment arm; ICSI control arm

Conventional manual sperm selection PROCEDURE

selection beased on motility at low magnification

BAIBYS+ICSI treatment arm; ICSI control arm

Eligibility Criteria

• Age: 21 Years - 42 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BAIBYS Fertility: lead

Study Sites (3)

New England Fertility Institute

Stamford, Connecticut, 06905, United States

Location

Assuta Medical Center

Tel Aviv, 6971028, Israel

Location

Care Fertility Group

Manchester, United Kingdom

Location

MeSH Terms

Conditions

Infertility, Male; Azoospermia

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Infertility; Male Urogenital Diseases

Central Study Contacts

David Rigler

CONTACT

+972545850624; david.rigler@baibys.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Software-based decision support automated device for ideal sperm selection for ICSI

Study Record Dates

• First Submitted: May 18, 2025
• First Posted: May 25, 2025
• Study Start: March 15, 2026
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): October 15, 2026
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1); GB (1); US (1)