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)

July 19, 2024 updated by: Ovation Fertility

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

155

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nevada
      • Las Vegas, Nevada, United States, 89113
        • Recruiting
        • Ovation Fertility Las Vegas
        • Contact:
        • Principal Investigator:
          • Matthew VerMilyea, PhD
    • Texas
      • Austin, Texas, United States, 78731
        • Recruiting
        • Ovation Fertility - Austin
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients seeking fertility treatment by ICSI.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
AI Asssited Sperm Selection
SiD software to select sperm for ICSI
Other: Artificial Intelligence assisted sperm selection
SiD software for sperm selection
Manual Sperm Selection
Human visualization of sperm for ICSI selection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Oocyte Fertilization
Time Frame: 1 day
Does SiD assist in ICSI Fertilization
1 day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blastocyst Formation
Time Frame: 7 days
Do embryos develop better from SiD oocytes
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ovation Fertility

Collaborators

IVF 2.0 Limited

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

July 19, 2024

First Submitted That Met QC Criteria

July 19, 2024

First Posted (Actual)

July 25, 2024

Study Record Updates

Last Update Posted (Actual)

July 25, 2024

Last Update Submitted That Met QC Criteria

July 19, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OVA-9-2022-TX

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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