Clinical trial 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.
Official title: SprmPik AI Assisted Sperm Selection Study, an Assistant for Sperm Selection During ICSI
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Infertility
Lead sponsor: Ovation Fertility
Sponsor class: OTHER
Collaborators: name: IVF 2.0 Limited
First posted: 2024-07-25
Enrollment: 155
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients seeking fertility treatment by ICSI.

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.

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 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.

Eligibility 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.

Primary outcomes:
measure: Oocyte Fertilization
timeFrame: 1 day
Secondary outcomes:
measure: Blastocyst Formation
timeFrame: 7 days
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: Ovation Fertility Las Vegas
state: Nevada
city: Austin
country: United States
facility: Ovation Fertility - Austin
state: Texas
Study officials:
References: