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.

Last updated: July 19, 2024
Sponsor: Ovation Fertility
Overall Status: Active - Recruiting

Phase

N/A

Condition

Infertility

Treatment

Artificial Intelligence assisted sperm selection

Clinical Study ID

NCT06518928
OVA-9-2022-TX
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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.

Study Design

Total Participants: 155
Treatment Group(s): 1
Primary Treatment: Artificial Intelligence assisted sperm selection
Phase:
Study Start date:
January 01, 2024
Estimated Completion Date:
October 01, 2026

Study 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.

Connect with a study center

  • Ovation Fertility Las Vegas

    Las Vegas, Nevada 89113
    United States

    Active - Recruiting

  • Ovation Fertility - Austin

    Austin, Texas 78731
    United States

    Active - Recruiting

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