AI-Assisted Sperm Selection for Infertility Treatment

This study is looking at how a new software called SiD can help with sperm selection during Intracytoplasmic Sperm Injection (ICSI), a type of medically assisted reproduction for infertility. SiD uses artificial intelligence to identify and select sperm based on their movement and shape. Researchers want to see if using SiD improves outcomes like fertilization rates, blastocyst (early embryo) development, and reduces early pregnancy loss. This is an observational study, meaning participants will receive standard care, and researchers will observe the effects of using SiD. The study plans to enroll 155 participants. To join, male partners must be undergoing IVF with ICSI, have motile sperm, and provide informed consent.

Study design
This is an observational study planning to enroll 155 participants. It will evaluate the impact of SiD software during ICSI.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, oocyte fertilization, is measured at 1 day. Other follow-up durations are not specified.

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NCT06518928

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
Not specifiedAll AgesObservational
Ovation Fertility
~155 participants
Updated 2024-07-25 on ClinicalTrials.gov
What's tested:Artificial Intelligence assisted sperm selection

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Oocyte Fertilization
Measured over 1 day
Infertility
2 sites across 2 states
Nevada1
Texas1

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Eligibility criteria

Inclusion

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

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.
  • Oocyte Fertilization1 day

    Does SiD assist in ICSI Fertilization