InfertilitySprmPikNCT06518928
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.
An observational study of Infertility, run by Ovation Fertility at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- Artificial Intelligence assisted sperm selection
- How many people
- 155 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jan 2024to 1 Oct 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients seeking fertility treatment by ICSI.
Who may be able to join
- 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
Show all 10Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Ovation Fertility - Austin
Austin, Texas, 78731
Matthew VerMilyea, PhD, 512-980-0310, tex@ovationfertility.com
- Recruiting
Ovation Fertility Las Vegas
Las Vegas, Nevada, 89113
Matthew VerMilyea, PhD, 512-980-0310, tex@ovationfertility.com
Matthew VerMilyea, PhD
About this study
Official title: SprmPik AI Assisted Sperm Selection Study, an Assistant for Sperm Selection During ICSI
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.
Read the 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.
- Conditions
- Infertility
- Being tested
- Artificial Intelligence assisted sperm selection
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Artificial Intelligence assisted sperm selectionOther
SiD software for sperm selection
| Study group | Role | What they receive |
|---|---|---|
| AI Asssited Sperm Selection | SiD software to select sperm for ICSI Receives: Other: Artificial Intelligence assisted sperm selection | |
| Manual Sperm Selection | Human visualization of sperm for ICSI selection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oocyte Fertilization
Does SiD assist in ICSI Fertilization
Measured: 1 day
Secondary outcomes (1)
Blastocyst Formation
Do embryos develop better from SiD oocytes
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2024
- Study start1 Jan 2024
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 155 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ovation Fertility
- Sponsor type
- University, hospital or other
- Collaborators
- IVF 2.0 Limited
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06518928
- Sponsor's protocol ID
- OVA-9-2022-TX
- Acronym
- SprmPik
- Status last verified
- Jul 2024
- First submitted
- 19 Jul 2024
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SprmPik AI Assisted Sperm Selection Study, an Assistant for Sperm Selection During ICSI
- ClinicalTrials.gov ID
- NCT06518928
- Acronym / sponsor ID
- SprmPik / OVA-9-2022-TX
- Conditions
- Infertility
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 155 participants (estimated)
- Lead sponsor
- Ovation FertilityUniversity, hospital or other
- Collaborators
- IVF 2.0 Limited
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 25 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AI Asssited Sperm Selection | – | Other: Artificial Intelligence assisted sperm selectionSiD software to select sperm for ICSI |
| Manual Sperm Selection | – | –Human visualization of sperm for ICSI selection |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients seeking fertility treatment by ICSI.
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Artificial Intelligence assisted sperm selectionSiD software for sperm selection | Other | AI Asssited Sperm Selection |
Primary outcome
Oocyte Fertilization
Time frame: 1 day
Does SiD assist in ICSI Fertilization
1 secondary outcome
Blastocyst Formation
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, run by Ovation Fertility at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oocyte Fertilization (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2024.