Status:

RECRUITING

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.

Lead Sponsor:

Ovation Fertility

Collaborating Sponsors:

IVF 2.0 Limited

Conditions:

Infertility

Eligibility:

All Genders

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 formatio...

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 develop...

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.

Exclusion

    Key Trial Info

    Start Date :

    January 1 2024

    Trial Type :

    OBSERVATIONAL

    Allocation :

    ESTIMATED

    End Date :

    October 1 2026

    Estimated Enrollment :

    155 Patients enrolled

    Trial Details

    Trial ID

    NCT06518928

    Start Date

    January 1 2024

    End Date

    October 1 2026

    Last Update

    July 25 2024

    Active Locations (2)

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    Page 1 of 1 (2 locations)

    1

    Ovation Fertility Las Vegas

    Las Vegas, Nevada, United States, 89113

    2

    Ovation Fertility - Austin

    Austin, Texas, United States, 78731

    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. | DecenTrialz