Male Infertility, AzoospermiaBenchmarkNCT06990906
Evaluating the Safety and Clinical Efficacy of the BAIBYS™ System in Intracytoplasmic Sperm Injection (ICSI)
A study testing BAIBYS Sperm selection, Intra cytoplasmatic sperm injection and Conventional manual sperm selection in people with Male Infertility, Azoospermia, run by BAIBYS Fertility at 3 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 42 yearsHealthy volunteers can take part
- Conditions the study is for
- Male Infertility, Azoospermia
- What is being tested?
- BAIBYS Sperm selection, Intra cytoplasmatic sperm injection and Conventional manual sperm selection
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 3 sitesin 3 countries
- Study dates
- 15 Mar 2026to 15 Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 42 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
3 sites in 3 countries
United States1 site
New England Fertility Institute
Stamford, Connecticut, 06905
Raga Rohaiem, PhD, 203 3253200, raga.rohaiem@nefertility.com
Israel1 site
Assuta Medical Center
Tel Aviv, 6971028
Gal Churi, Msc, +972 3 7644924, galch@assuta.co.il
About this study
Official title: BENCHMARK SPERM: A Prospective, Randomized Controlled Study Evaluating the Safety and Clinical Efficacy of the BAIBYS™ System in Intracytoplasmic Sperm Injection (ICSI)
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.
Read more
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.
Read the detailed description
The BAIBYS™ System is an automated microscopy-based tool intended to assist embryologists in selecting ideal spermatozoa based on morphological characteristics and motility for the Intra Cytoplasmic Sperm Injection (ICSI) procedure. It employs computer-vision machine learning algorithms trained with high-magnification live cell imagery. The system is indicated for adults who are undergoing the ICSI procedure.
Prospective, multi-center, two-arms (standard ICSI+BAIBYS™ vs. Standard ICSI only) randomized controlled study.
- The sperm selection methodology utilized in the BAIBYS™ System for ICSI serves as a software-based decision-support tool. The embryologist retains the final decision regarding the utilization of the sperm that has been chosen by the apparatus.
- The determination of the selected embryo for transferring to the uterine cavity and cryopreservation is based on the best conventional clinical practice. The study design directs only in cases of multiple decision options in order to maintain the balance between the sample size of the study cohorts.
- Each female participant will be equally randomized to either the BAIBYS™ arm or the Control arm. This randomization will determine the oocyte (extra) allocation, ICSI timing, and embryo transfer:
- The extra oocyte in case of an odd number will be assigned to the arm per the randomization plan
- The injection of spermatozoa from both arms will be administered as close as possible. Priority will be given according to the randomization plan.
- The embryo designated for transfer into the uterus will be selected based on the randomization plan in case the two best embryos from different arms exhibit similar quality assessment grading.
- The embryologists who inject sperm into the oocytes of both arms will remain blind to the study arm from which the sperm originated. The selected sperm in each arm will be transferred to a new ICSI dish in which the allocated oocytes are placed.
- Conditions
- Male Infertility, Azoospermia
- Being tested
- BAIBYS Sperm selection, Intra cytoplasmatic sperm injection, Conventional manual sperm selection
- Keywords
- ICSI, ART, Oocyte, Spermatozoa, Blastocyst
- Medical subject headings
- Infertility, Male, Azoospermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BAIBYS Sperm selectionDevice
Software based decision support device for sperm selction based on morphology and motility
Intra cytoplasmatic sperm injectionProcedure or surgery
Sperm injection into oocytes for ferilization
Conventional manual sperm selectionProcedure or surgery
selection beased on motility at low magnification
| Study group | Role | What they receive |
|---|---|---|
| BAIBYS+ICSI treatment arm | Experimental | Oocytes of this group will be fertilized with sperm selcted by the BAIBYS System Receives: 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 Receives: Procedure: Intra cytoplasmatic sperm injection; Procedure: Conventional manual sperm selection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Co-primary: Usable Blastocyte formation rate and Clinical Pregnancy rate
A co-primary clinical performance endpoint.
- 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).
- 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
Measured: 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
Measured: 1-day post-ICSI
Secondary outcomes (3)
Procedure Efficiency
The median time for selection of a spermatozoon by the BAIBYS™ System is ≤ 3 minutes
Measured: ICSI day 0
Pregnancy rate
The rate of clinical pregnancy in weeks 6-8, as indicated by the presence of a normal heartbeat, within the BAIBYS™ treatment cohort transferred embryos is ≥ 35% or is at least 5% higher than in the standard ICSI treatment cohort
Measured: 6-8 weeks post embryo transfer
Fertilization rate
The rate of oocyte fertilization within the BAIBYS™ treatment cohort (defined as the proportion of oocytes exhibiting two pronuclei or undergoing cellular division at 16-18 hours post-ICSI) exceeds 65% or is at least 5% higher than in the standard ICSI treatment cohort
Measured: 16-18 hours post-ICSI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2025
- Study start15 Mar 2026 (estimated)
- Primary completion15 Aug 2026 (estimated)
- Study completion15 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Male Infertility, AzoospermiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Software-based decision support automated device for ideal sperm selection for ICSI
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BAIBYS Fertility
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06990906
- Sponsor's protocol ID
- CLN-009
- Acronym
- Benchmark
- Status last verified
- Jan 2026
- First submitted
- 18 May 2025
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BENCHMARK SPERM: A Prospective, Randomized Controlled Study Evaluating the Safety and Clinical Efficacy of the BAIBYS™ System in Intracytoplasmic Sperm Injection (ICSI)
- ClinicalTrials.gov ID
- NCT06990906
- Acronym / sponsor ID
- Benchmark / CLN-009
- Conditions
- Male Infertility, Azoospermia
- Keywords
- ICSI, ART, Oocyte, Spermatozoa, Blastocyst
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- BAIBYS FertilityIndustry (pharma, biotech, devices)
- Study start
- 15 Mar 2026 (estimated)
- Primary completion
- 15 Aug 2026 (estimated)
- Study completion
- 15 Oct 2026 (estimated)
- First posted
- 25 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The BAIBYS™ System is an automated microscopy-based tool intended to assist embryologists in selecting ideal spermatozoa based on morphological characteristics and motility for the Intra Cytoplasmic Sperm Injection (ICSI) procedure. It employs computer-vision machine learning algorithms trained with high-magnification live cell imagery. The system is indicated for adults who are undergoing the ICSI procedure.
Prospective, multi-center, two-arms (standard ICSI+BAIBYS™ vs. Standard ICSI only) randomized controlled study.
- The sperm selection methodology utilized in the BAIBYS™ System for ICSI serves as a software-based decision-support tool. The embryologist retains the final decision regarding the utilization of the sperm that has been chosen by the apparatus.
- The determination of the selected embryo for transferring to the uterine cavity and cryopreservation is based on the best conventional clinical practice. The study design directs only in cases of multiple decision options in order to maintain the balance between the sample size of the study cohorts.
- Each female participant will be equally randomized to either the BAIBYS™ arm or the Control arm. This randomization will determine the oocyte (extra) allocation, ICSI timing, and embryo transfer:
- The extra oocyte in case of an odd number will be assigned to the arm per the randomization plan
- The injection of spermatozoa from both arms will be administered as close as possible. Priority will be given according to the randomization plan.
- The embryo designated for transfer into the uterus will be selected based on the randomization plan in case the two best embryos from different arms exhibit similar quality assessment grading.
- The embryologists who inject sperm into the oocytes of both arms will remain blind to the study arm from which the sperm originated. The selected sperm in each arm will be transferred to a new ICSI dish in which the allocated oocytes are placed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Software-based decision support automated device for ideal sperm selection for ICSI
| Arm | Type | Receives |
|---|---|---|
| BAIBYS+ICSI treatment arm | Experimental | Device: BAIBYS Sperm selection, Procedure: Intra cytoplasmatic sperm injection, Procedure: Conventional manual sperm selectionOocytes of this group will be fertilized with sperm selcted by the BAIBYS System |
| ICSI control arm | Active comparator | Procedure: Intra cytoplasmatic sperm injection, Procedure: Conventional manual sperm selectionOocytes of this group will be fertilized with sperm selcted by conventional manual procedre |
Who may qualify
- Ages
- 21 to 42 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BAIBYS Sperm selectionSoftware based decision support device for sperm selction based on morphology and motility | Device | BAIBYS+ICSI treatment arm |
| Intra cytoplasmatic sperm injectionSperm injection into oocytes for ferilization | Procedure or surgery | BAIBYS+ICSI treatment arm, ICSI control arm |
| Conventional manual sperm selectionselection beased on motility at low magnification | Procedure or surgery | BAIBYS+ICSI treatment arm, ICSI control arm |
Primary outcome
Co-primary: Usable Blastocyte formation rate and Clinical Pregnancy rate
Time frame: 5-6 days post ICSI and 7 weeks post embryo transfer
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
Irreversible SADE
Time frame: 1-day post-ICSI
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
3 secondary outcomes
Procedure Efficiency
Time frame: ICSI day 0
Pregnancy rate
Time frame: 6-8 weeks post embryo transfer
Fertilization rate
Time frame: 16-18 hours post-ICSI
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BAIBYS Sperm selection, Intra cytoplasmatic sperm injection and Conventional manual sperm selection in people with Male Infertility, Azoospermia, run by BAIBYS Fertility at 3 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States, Israel, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact David Rigler (+972545850624, david.rigler@baibys.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.