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
SprmPik AI Assisted Sperm Selection Study, an Assistant for Sperm Selection During ICSI
1 other identifier
observational
155
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2024
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2024
CompletedFirst Submitted
Initial submission to the registry
July 19, 2024
CompletedFirst Posted
Study publicly available on registry
July 25, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2026
ExpectedJuly 25, 2024
July 1, 2024
2 years
July 19, 2024
July 19, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Oocyte Fertilization
Does SiD assist in ICSI Fertilization
1 day
Secondary Outcomes (1)
Blastocyst Formation
7 days
Study Arms (2)
AI Asssited Sperm Selection
SiD software to select sperm for ICSI
Manual Sperm Selection
Human visualization of sperm for ICSI selection
Interventions
SiD software for sperm selection
Eligibility Criteria
Patients seeking fertility treatment by ICSI.
You may qualify if:
- 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
You may not qualify if:
- 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
- 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.
- Inability to reliably trace sperm-oocyte-embryo throughout the process.
- Oocytes that are not in Metaphase II.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ovation Fertilitylead
- IVF 2.0 Limitedcollaborator
Study Sites (2)
Ovation Fertility Las Vegas
Las Vegas, Nevada, 89113, United States
Ovation Fertility - Austin
Austin, Texas, 78731, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 19, 2024
First Posted
July 25, 2024
Study Start
January 1, 2024
Primary Completion
January 1, 2026
Study Completion (Estimated)
October 1, 2026
Last Updated
July 25, 2024
Record last verified: 2024-07