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Recruiting NCT06518928

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.

Observational Infertility

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 →
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

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗