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.

Recruiting

• Conditions: Infertility
• Interventions: Other: Artificial Intelligence assisted sperm selection

• Registration Number: NCT06518928
• Lead Sponsor: Ovation Fertility

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.

Study Timeline

• Study Start: 2024-01-01
• Status Verified: 2024-07
• Study First Submitted: 2024-07-19
• Study First Submitted QC: 2024-07-19
• Last Update Submitted: 2024-07-19
• Study First Posted: 2024-07-25
• Last Update Posted: 2024-07-25
• Primary Completion: 2026-01-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 155

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
AI Asssited Sperm Selection	Artificial Intelligence assisted sperm selection	SiD software to select sperm for ICSI

Primary Outcome Measures

Name	Time	Method
Oocyte Fertilization	1 day	Does SiD assist in ICSI Fertilization

Secondary Outcome Measures

Name	Time	Method
Blastocyst Formation	7 days	Do embryos develop better from SiD oocytes

Trial Locations

Locations (2)

Ovation Fertility - Austin; 🇺🇸 Austin, Texas, United States

Ovation Fertility Las Vegas; 🇺🇸 Las Vegas, Nevada, United States