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.

NCT ID: NCT06518928

Last Updated: 2024-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

155 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2026-10-01

Brief Summary

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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

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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.

Conditions

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Infertility

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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AI Asssited Sperm Selection

SiD software to select sperm for ICSI

Artificial Intelligence assisted sperm selection

Intervention Type OTHER

SiD software for sperm selection

Manual Sperm Selection

Human visualization of sperm for ICSI selection

No interventions assigned to this group

Interventions

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Artificial Intelligence assisted sperm selection

SiD software for sperm selection

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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


* 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

* 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


* Inability to reliably trace sperm-oocyte-embryo throughout the process.
* Oocytes that are not in Metaphase II.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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IVF 2.0 Limited

OTHER

Sponsor Role collaborator

Ovation Fertility

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Ovation Fertility Las Vegas

Las Vegas, Nevada, United States

Site Status RECRUITING

Ovation Fertility - Austin

Austin, Texas, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Matthew VerMilyea, PhD

Role: primary

512-980-0310

Matthew VerMilyea, PhD

Role: primary

512-980-0310

Other Identifiers

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OVA-9-2022-TX

Identifier Type: -

Identifier Source: org_study_id

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