Skip to content

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.

SprmPik AI Assisted Sperm Selection Study, an Assistant for Sperm Selection During ICSI

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06518928
Acronym
SprmPik
Enrollment
155
Registered
2024-07-25
Start date
2024-01-01
Completion date
2026-10-01
Last updated
2024-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infertility

Brief summary

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

OTHERArtificial Intelligence assisted sperm selection

SiD software for sperm selection

Sponsors

IVF 2.0 Limited
CollaboratorOTHER
Ovation Fertility
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Oocyte Fertilization1 dayDoes SiD assist in ICSI Fertilization

Secondary

MeasureTime frameDescription
Blastocyst Formation7 daysDo embryos develop better from SiD oocytes

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026