Status:
RECRUITING
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.
Lead Sponsor:
Ovation Fertility
Collaborating Sponsors:
IVF 2.0 Limited
Conditions:
Infertility
Eligibility:
All Genders
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 formatio...
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 develop...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
January 1 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2026
Estimated Enrollment :
155 Patients enrolled
Trial Details
Trial ID
NCT06518928
Start Date
January 1 2024
End Date
October 1 2026
Last Update
July 25 2024
Active Locations (2)
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1
Ovation Fertility Las Vegas
Las Vegas, Nevada, United States, 89113
2
Ovation Fertility - Austin
Austin, Texas, United States, 78731