An interventional study of BAIBYS Sperm selection and Intra cytoplasmatic sperm injection in Male Infertility, Azoospermia, sponsored by BAIBYS Fertility. Not yet recruiting at 3 sites in 3 countries. Open to participants aged 21 Years to 42 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-15.
Sponsored by BAIBYS Fertility · Not applicable, Interventional, and Treatment
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.
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.
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:
59 studies on the registry are indexed under Azoospermia; 17 are open to participants now.
This study's planned enrollment of 260 is above the median of 57 across 32 interventional studies indexed under Azoospermia.
Browse Azoospermia studies →BAIBYS Fertility is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Compared within Azoospermia, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Infertility, Male. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Oocytes of this group will be fertilized with sperm selcted by conventional manual procedre
Procedure: Intra cytoplasmatic sperm injection · Procedure: Conventional manual sperm selection
Software based decision support device for sperm selction based on morphology and motility
Sperm injection into oocytes for ferilization
selection beased on motility at low magnification
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
Time frame: 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
Time frame: 1-day post-ICSI
Procedure Efficiency
The median time for selection of a spermatozoon by the BAIBYS™ System is ≤ 3 minutes
Time frame: 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
Time frame: 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
Time frame: 16-18 hours post-ICSI
Blastocyte formation rate as a function of 2PN zygote
A comparative analysis of the proportion of usable blastocyte development on day 5/6 as a function of 2PN zygote across both study arms
Time frame: 5-6 days post ICSI
Implantation rate
A comparative analysis of the proportion of successful implantation across both study arms
Time frame: 1 day post embryo transfer
Biochemistry pregnancy rate
A comparative analysis of the proportion of pregnancy, as indicated by the presence of positive HCG on days 12 to 14 post-embryo transfer across both study arms
Time frame: 12 to 14 post-embryo transfer
Plan to share: No
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This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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BAIBYS Fertility