SprmPik AI Sperm Selection Study SiD, an Assistant for Sp... | NCT06518928

Studies
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.

NCT06518928

Sponsor

Ovation Fertility

Status

Recruiting

Last Update Posted

Jul 25, 2024Actual

Enrollment

155Estimated

Phase

Not provided

Conditions

Infertility

Interventions

Artificial Intelligence assisted sperm selection

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2024Actual

Primary Completion Date

Jan 1, 2026Estimated

Completion Date

Oct 1, 2026Estimated

First Submitted Date

Jul 19, 2024

First Submission Date that Met QC Criteria

Jul 19, 2024

First Posted Date

Jul 25, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 19, 2024

Last Update Posted Date

Jul 25, 2024Actual

Name	Class
IVF 2.0 Limited	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

155Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
AI Asssited Sperm Selection		SiD software to select sperm for ICSI	Other: Artificial Intelligence assisted sperm selection
Manual Sperm Selection		Human visualization of sperm for ICSI selection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Artificial Intelligence assisted sperm selection	Other	SiD software for sperm selection	AI Asssited Sperm Selection

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Patients seeking fertility treatment by ICSI.

Sampling Method

Non-Probability Sample

ID	Term
D000091662	Genital Diseases
D000091642	Urogenital Diseases