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.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Artificial Intelligence assisted sperm selection.
- Who it may be relevant to
- Registry conditions: Infertility. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
SprmPik AI Assisted Sperm Selection Study, an Assistant for Sperm Selection During ICSI
Overview
SprmPik AI Assisted 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.
Detailed description
The purpose of this research is to evaluate the impact of sperm selection for ICSI using the investigational SiD software, on performance outcomes such as the rate of fertilization, blastocyst development, clinical pregnancy success, and other intermediate results, in a pilot study.
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.
Interventions
- Other Artificial Intelligence assisted sperm selection
SiD software for sperm selection
Primary outcome measures
- Oocyte Fertilization [Time frame: 1 day]
Secondary outcome measures (1)
- Blastocyst Formation [Time frame: 7 days]
Eligibility criteria
Inclusion criteria for Male Partner (sperm source)
- Informed consent signed by the patient before treatment.
- 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
Exclusion criteria for Male Partner (sperm source)
- Sperm extracted by testicular biopsy.
- 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
Inclusion criteria for Female Partner (egg source)
- 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 for Female Partner (egg source)
- Inability to reliably trace sperm-oocyte-embryo throughout the process.
- Oocytes that are not in Metaphase II.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Case-control
Study locations
United States · 2 centers
- Ovation Fertility Las Vegas — Las Vegas
- Ovation Fertility - Austin — Austin
Identifiers
NCT: NCT06518928 · OVA-9-2022-TX