Status:
NOT_YET_RECRUITING
Evaluate the Clinical Performance and Safety of the BAIBYS™ System in Selecting Spermatozoa for the ICSI Procedure
Lead Sponsor:
BAIBYS Fertility
Conditions:
Male Infertility, Azoospermia
Eligibility:
All Genders
21-42 years
Phase:
NA
Brief 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...
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 S...
Eligibility Criteria
Inclusion
- 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
- Female subjects aged 21 to 42 years at the time of screening
- Number of follicles ≥13 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
Exclusion
- 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).
- Frozen/thawed oocytes.
- 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
Key Trial Info
Start Date :
July 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 15 2026
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT06990906
Start Date
July 15 2025
End Date
March 15 2026
Last Update
May 25 2025
Active Locations (3)
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1
New England Fertility Institute
Stamford, Connecticut, United States, 06905
2
Assuta Medical Center
Tel Aviv, Israel, 6971028
3
Care Fertility Group
Manchester, United Kingdom