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 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.

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Key information

Conditions

Infertility Genital Diseases Urogenital Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Ovation Fertility Las Vegas, Las Vegas, Nevada, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Artificial Intelligence assisted sperm selection

Other

SiD software for sperm selection

Primary outcomes

Oocyte Fertilization

Time frame: 1 day

Does SiD assist in ICSI Fertilization

Secondary outcomes

Blastocyst Formation

Time frame: 7 days

Do embryos develop better from SiD oocytes

Sponsors and collaborators

Lead sponsor

Ovation Fertility

Other

Collaborators

IVF 2.0 Limited

Registry information

Official study title

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

Acronym: SprmPik

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2026
First posted: Jul 25, 2024
Registry last updated: Jul 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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