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.

Ovation Fertility

Status: Enrolling

Conditions: Infertility

Treatments: Other: Artificial Intelligence assisted sperm selection

Study type: Observational

Funder types: Other

Identifiers

NCT06518928

OVA-9-2022-TX

Details and patient eligibility

About

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.

Full 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.

Enrollment: 155 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

155 participants in 2 patient groups

AI Asssited Sperm Selection

Description:

SiD software to select sperm for ICSI

Treatment:

Other: Artificial Intelligence assisted sperm selection

Manual Sperm Selection

Description:

Human visualization of sperm for ICSI selection