Evaluating the BAIBYS™ System for ICSI in Male Infertility
This study is looking at a new, automated technology called the BAIBYS™ System. It uses artificial intelligence (AI) to help embryologists choose the best sperm for a procedure called Intracytoplasmic Sperm Injection (ICSI). ICSI is a common treatment for infertility where a single sperm is injected into an egg. The BAIBYS™ System aims to improve sperm selection by looking at both movement and shape, which current methods might miss. We want to see if using BAIBYS™ leads to more high-quality embryos and successful pregnancies compared to the standard way of selecting sperm. You might be able to join if you are between 21 and 42 years old, of any gender, and are planning to undergo ICSI treatment. The study is currently unclear on its recruitment status and plans to enroll 260 participants.
- Study design
- This is a prospective, multi-center study with two groups. Participants will be randomly assigned to either receive ICSI with the BAIBYS™ System or standard ICSI.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will measure outcomes at 5-6 days after ICSI and 7 weeks after embryo transfer, and irreversible serious adverse events 1 day after ICSI.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Evaluating the Safety and Clinical Efficacy of the BAIBYS™ System in Intracytoplasmic Sperm Injection (ICSI)
At a glance
Conditions
Where it's being run
3 sites across 3 statesWho to contact
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What this trial measures
- Co-primary: Usable Blastocyte formation rate and Clinical Pregnancy rate5-6 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 SADE1-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