Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06990906 · ClinicalTrials.gov registry record · NA
Evaluating the Safety and Clinical Efficacy of the BAIBYS™ System in Intracytoplasmic Sperm Injection (ICSI)
A NA study, sponsored by BAIBYS Fertility.
- Not yet
- Registry status
- NA
- Development phase
- 260
- Enrollment target
NCT06990906 is a NA study that has not yet begun recruiting, run by BAIBYS Fertility. The registered enrollment target is 260 participants.
The verdict
NCT06990906, a NA study, has not yet begun recruiting, sponsored by BAIBYS Fertility.
- NOT YET RECRUITING
- Registry status
- NA
- Development phase
- 260 participants
- Enrollment target
Study 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
Interventions
- DEVICE BAIBYS Sperm selection
- PROCEDURE Intra cytoplasmatic sperm injection
- PROCEDURE Conventional manual sperm selection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 260 participants |
| Start Date | 2026-03-15 |
| Est. Completion | 2026-10-15 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06990906
The ClinicalTrials.gov registry entry for NCT06990906 describes a study currently listed as not yet recruiting, categorized as NA. The registered enrollment target is 260 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is BAIBYS Fertility, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which BAIBYS Sperm selection is the first listed.
NCT06990906 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06990906 about?
NCT06990906 is a clinical study titled "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 pregna...
What is the current status of trial NCT06990906?
This trial is currently not yet recruiting. It is a NA study. The enrollment target is 260 participants. The study started on 2026-03-15. Estimated completion is 2026-10-15.
What interventions are being tested in trial NCT06990906?
The interventions under investigation include: BAIBYS Sperm selection (DEVICE), Intra cytoplasmatic sperm injection (PROCEDURE), Conventional manual sperm selection (PROCEDURE).
Who is sponsoring clinical trial NCT06990906?
This trial is sponsored by BAIBYS Fertility, which has 2 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.