Not yet recruitingNAINTERVENTIONAL

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

This study is looking at a new, automated system called BAIBYS that uses artificial intelligence (AI) to help select the best sperm for a fertility treatment called Intra-Cytoplasmic Sperm Injection (ICSI). ICSI is used when male infertility is an issue, and it involves injecting a single sperm into an egg. Currently, sperm are chosen manually under a microscope, which can be time-consuming and rely on the embryologist's skill. The BAIBYS system aims to make this process more accurate and consistent by automatically selecting sperm based on their movement, shape, and size. We want to find out if using BAIBYS leads to better quality embryos, more successful pregnancies, and healthy babies compared to the standard method.

At a glance

Status

Not yet recruiting

Phase

Sponsor

BAIBYS Fertility

Enrolment target

260

Start

15 Mar 2026

Estimated completion

15 Oct 2026

Male Infertility, Azoospermia

What is this study about?

This study is about improving a fertility treatment called Intra-Cytoplasmic Sperm Injection, or ICSI. ICSI is often used when couples are having trouble getting pregnant due to male infertility. In this treatment, specially trained laboratory scientists, called embryologists, pick a single sperm and inject it into an egg to help it fertilise. Normally, embryologists choose sperm by looking at them moving under a microscope, but this method might miss problems with the sperm's shape that could affect its quality. Recent research suggests that looking at sperm in more detail, using higher magnification, can lead to better embryos, fewer birth defects, and higher chances of a healthy baby.

However, carefully choosing sperm this way by hand takes a lot of time and depends on the individual embryologist's skills. This means that two different embryologists might pick different sperm. Scientists are very interested in using a type of computer technology called Artificial Intelligence (AI) to make this process more precise, consistent, and quicker. We believe AI could help ensure that the very best sperm are chosen every time.

That's where the BAIBYS™ System comes in. It's a new, computer-based tool that uses AI to automatically pick sperm based on how they move, their size, and their shape. These features give clues about whether a sperm is likely to be normal and lead to a good embryo. The system even puts the selected sperm into different areas so the embryologist can easily find them for injection. This study is an important step to see if this new device really does help fertility treatments and makes a positive difference for couples hoping to have a baby.

Key takeaways

Testing new AI tech (BAIBYS) for sperm selection in IVF (ICSI).
Aims for better embryo quality and higher pregnancy success.
Compares AI selection to standard manual methods.
Half your eggs will use AI-selected sperm, half traditional.
Your embryologist always has the final say on sperm and embryo selection.
Participation is voluntary and won't affect your treatment choices.

Who may be eligible?

This study is for couples who are planning to have ICSI as part of their IVF treatment. This includes couples using their own eggs and sperm, or those using sperm from a known donor. Both partners will need to meet certain age requirements: the male partner must be at least 21 years old, and the female partner must be between 21 and 42 years old.

For men, you would be eligible if your sperm analysis shows at least one issue with sperm count, movement, or shape, according to standard health guidelines. You also need to be able to provide a sperm sample by ejaculation, which can be fresh or frozen, and it needs to have a certain amount of moving sperm. For women, you would need to have at least 11 eggs that are a good size when measured by ultrasound before egg collection.

There are also some reasons why you might not be able to join. For example, if the female partner has severe endometriosis or another condition that makes pregnancy very unlikely, or if the male partner needs sperm to be surgically extracted from the testicles. You also can't be taking part in another study that might affect this one, or currently receiving cancer treatment. The study also wouldn't be suitable if you're planning to choose the baby's sex or if your donor situation makes it hard to get proper consent.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are both partners aged between 21 and 42 (woman) or at least 21 (man)?
Are you planning to have ICSI treatment?
Does the man have some issues with sperm count, movement, or shape?
Can the man provide a sperm sample by ejaculation?
Does the woman usually produce at least 11 good-sized eggs during egg collection?
Are you not currently receiving cancer treatment or participating in conflicting studies?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, during your IVF cycle, half of the eggs collected from you will be fertilised using sperm chosen by the new BAIBYS™ System. The other half will be fertilised using sperm selected by the standard method at your clinic. Don't worry, an embryologist will always check to make sure the sperm selected by the BAIBYS system are suitable. After fertilisation, the best embryo overall, regardless of how the sperm was chosen, will be picked for transfer into your womb to try for a pregnancy. Any other good quality embryos will be frozen for future use, following your clinic's usual procedures.

This study is designed so that the embryologists injecting the sperm won't know which method was used to select the sperm for each egg. The system will make sure that the sperm from each method are placed in separate dishes. The total duration of your participation would be from your initial screening through to the embryo transfer and any follow-up related to the outcome of that pregnancy.

Potential risks and benefits

Taking part in this study might offer the benefit of potentially using a more advanced and precise method for sperm selection, which could lead to better quality embryos and an increased chance of a successful pregnancy. However, as this is a new technology, there might be unknown risks, and the benefits are not guaranteed. There is always the standard risk associated with any IVF treatment. You have the right to withdraw from the study at any time without it affecting your ongoing medical care.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

New England Fertility Institute
Verified postcode
Stamford, United States
Assuta Medical Center
Verified postcode
Tel Aviv, Israel
Care Fertility Group
Verified postcode
Manchester, United Kingdom

Common questions

What is ICSI?

ICSI (Intra-Cytoplasmic Sperm Injection) is a fertility treatment where a single sperm is injected directly into an egg to help fertilisation.

What is the BAIBYS™ System?

It's a new automated system that uses Artificial Intelligence (AI) to help embryologists pick the best sperm for ICSI based on their movement, size, and shape.

Will this study affect my chances of getting pregnant?

The study aims to improve the chances of a healthy pregnancy by potentially selecting better sperm, but like any treatment, success is not guaranteed.

Who decides which embryo gets transferred?

The best embryo, decided by standard clinical guidelines, will be chosen for transfer, regardless of which sperm selection method was used.

Can I choose not to take part?

Yes, taking part in this study is completely voluntary, and your decision will not affect your care.

How to find out more

David Rigler

david.rigler@baibys.com +972545850624 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.