SprmPik AI Sperm Selection Study SiD, an Assistant for Sperm Selection During Intracytoplasmic Sperm Injection in Medically Assisted Reproduction: Effect on Fertilization, Blastocyst Formation, Early Pregnancy Loss, and Consistent Practice. A Prospective Pilot Study.
NCT ID: NCT06518928
Last Updated: 2024-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
155 participants
OBSERVATIONAL
2024-01-01
2026-10-01
Brief Summary
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Detailed Description
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SiD is a software designed to identify, evaluate, and assist in the sperm selection process within a semen sample, according to motility (for instance velocity, linearity, straightness) patterns and the shape of the sperm. SID uses a mathematical model. Its purpose is to assist clinical embryologists in selecting sperm to inject during ICSI. Currently, embryologists identify and select sperm based on the sperm motility and shape; not using any mathematical interphase assistant.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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AI Asssited Sperm Selection
SiD software to select sperm for ICSI
Artificial Intelligence assisted sperm selection
SiD software for sperm selection
Manual Sperm Selection
Human visualization of sperm for ICSI selection
No interventions assigned to this group
Interventions
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Artificial Intelligence assisted sperm selection
SiD software for sperm selection
Eligibility Criteria
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Inclusion Criteria
* IVF treatments with medical or embryology indication to perform ICSI.
* Fresh or frozen ejaculated motile sperm.
* Selection of sperm using a 7% or 10% PVP solution.
* Presence of motile sperm at the time of sperm selection for ICSI.
* Partner sperm
* Informed consent signed by the patient before treatment.
* IVF treatments with medical or embryology indication to perform ICSI.
* Cycles with at least 4 mature oocytes (Metaphase II).
* Fresh or frozen oocytes.
Exclusion Criteria
* That the recommendations for use of SiD have not been fully followed.
* Inability to reliably trace sperm-oocyte-embryo throughout the process.
* Patients with immotile sperm
* Inability to reliably trace sperm-oocyte-embryo throughout the process.
* Oocytes that are not in Metaphase II.
ALL
Yes
Sponsors
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IVF 2.0 Limited
OTHER
Ovation Fertility
OTHER
Responsible Party
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Locations
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Ovation Fertility Las Vegas
Las Vegas, Nevada, United States
Ovation Fertility - Austin
Austin, Texas, United States
Countries
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Facility Contacts
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Other Identifiers
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OVA-9-2022-TX
Identifier Type: -
Identifier Source: org_study_id
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