Sperm ClassificationNCT06150846
Sperm Video Recording Protocol
An observational study of Sperm Classification, run by BAIBYS Fertility at 1 site in United States.
Trial summary
The purpose of this study is to obtain anonymous video clips of male semen at high magnification, to manually select out of the video spermatozoon images, and to manually classify their morphology by qualified embryologists based on the WHO Manual criteria in order to train the BAIBYS™ Fertility System. Read more about this study
- Who is it for?
- Ages 22 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- Sperm Classification
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2023to 1 Aug 2024
- 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 22 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study will enroll 30-40 male subjects attending the clinic and willing to contribute their unused excess sample materials from semen analysis or IVF/ICSI. Enrollment will include three sub-populations of at least 15 patients to ensure diversity [characteristics of ethnic and racial diversity, BMI diversity, and normal (> WHO 5%ile cutoffs) versus abnormal morphology].
Who may be able to join
- Assigned male at birth and possessing typical male anatomy (i.e., one or two testicles and penis)
- Scheduled to produce a semen sample for fertility evaluation
- Able to produce a semen sample, including, in the judgement of the PI, ability to follow instructions provided in English by the physician or physician's team members
- At least a 10th grade education level, to be able to read and understand the ICF; evaluated by either completion of 10th grade, or by any higher level of education or GED
- Age 22 or older at the time of consent
Who cannot join
- Known azoospermia prior to semen analysis.
- Subjects with azoospermia or otherwise inadequate sample discovered during the trial will be compensated for their participation in recognition of their efforts to contribute to science, but will be replaced with an additional subject for the data collection and labeling to reach a total sample of up to 40 videos
- History of chemotherapy or radiation within prior 12 months, due to increased chance of azoospermia
- Developmental delays or other neurological impairment that could impair ability to freely consent, as evaluated by the PI
- Any reason why in the sole judgement of the PI, consent to participate cannot be freely given
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to obtain anonymous video clips of male semen at high magnification, to manually select out of the video spermatozoon images, and to manually classify their morphology by qualified embryologists based on the WHO Manual criteria in order to train the BAIBYS™ Fertility System. The study will enroll males attending the clinic who may elect to contribute their unused excess sample materials from semen analysis or IVF/ICSI (Intracytoplasmic sperm injection) which is a technique used during in vitro fertilization (IVF).
Read the detailed description
The study will obtain video clips of 40 male subjects semen sample at high magnification. Each subject contributes 1 sample from which 10 minutes of video is recorded.
A total of 720,000 frames are expected to be collected at 30 frames per second. At least 6,000 frames will be selected at random from these 10,800-14,500 frames to be labeled by at least two embryologists. The sperm morphology will be rated according to the Kruger criteria per the WHO 6th edition. The data collected will be utilized to train the Artificial Intelligence (AI) used within the BAIBYS System.
- Conditions
- Sperm Classification
- Keywords
- Sperm, Artificial Inteligence
What is being measured
The primary outcome is the main question the study is designed to answer.
Obtaining 6,000 classified sperm images
Obtaining 6,000 sperm images classified each by at least 2 embryologist based on the WHO 6th edition criteria to add to the AI training of the Baibys system.
Measured: Each semen sample will be recorded for 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2023
- Study start1 Dec 2023
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sperm ClassificationStudies 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 only
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BAIBYS Fertility
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Carter Owen, M.D., Principal investigator, CCRM Fertility Clinic and IVF Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06150846
- Sponsor's protocol ID
- BCP-002 Sperm VR Trial
- Status last verified
- Jul 2024
- First submitted
- 21 Nov 2023
- Last updated
- 23 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymized patient's data including selection of sperm images/videos will be used together with the clinical study report and protocol will be shared to the medical writer and the supervisor author for the purpose of the the final publication.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sperm Video Recording Protocol
- ClinicalTrials.gov ID
- NCT06150846
- Acronym / sponsor ID
- BCP-002 Sperm VR Trial
- Conditions
- Sperm Classification
- Keywords
- Sperm, Artificial Inteligence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- BAIBYS FertilityIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 29 Nov 2023 (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.
The purpose of this study is to obtain anonymous video clips of male semen at high magnification, to manually select out of the video spermatozoon images, and to manually classify their morphology by qualified embryologists based on the WHO Manual criteria in order to train the BAIBYS™ Fertility System. The study will enroll males attending the clinic who may elect to contribute their unused excess sample materials from semen analysis or IVF/ICSI (Intracytoplasmic sperm injection) which is a technique used during in vitro fertilization (IVF).
Detailed description
The study will obtain video clips of 40 male subjects semen sample at high magnification. Each subject contributes 1 sample from which 10 minutes of video is recorded.
A total of 720,000 frames are expected to be collected at 30 frames per second. At least 6,000 frames will be selected at random from these 10,800-14,500 frames to be labeled by at least two embryologists. The sperm morphology will be rated according to the Kruger criteria per the WHO 6th edition. The data collected will be utilized to train the Artificial Intelligence (AI) used within the BAIBYS System.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 22 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study will enroll 30-40 male subjects attending the clinic and willing to contribute their unused excess sample materials from semen analysis or IVF/ICSI. Enrollment will include three sub-populations of at least 15 patients to ensure diversity [characteristics of ethnic and racial diversity, BMI diversity, and normal (> WHO 5%ile cutoffs) versus abnormal morphology].
Key inclusion criteria (5 listed)
- Assigned male at birth and possessing typical male anatomy (i.e., one or two testicles and penis)
- Scheduled to produce a semen sample for fertility evaluation
- Able to produce a semen sample, including, in the judgement of the PI, ability to follow instructions provided in English by the physician or physician's team members
- At least a 10th grade education level, to be able to read and understand the ICF; evaluated by either completion of 10th grade, or by any higher level of education or GED
- Age 22 or older at the time of consent
Key exclusion criteria (5 listed)
- Known azoospermia prior to semen analysis.
- Subjects with azoospermia or otherwise inadequate sample discovered during the trial will be compensated for their participation in recognition of their efforts to contribute to science, but will be replaced with an additional subject for the data collection and labeling to reach a total sample of up to 40 videos
- History of chemotherapy or radiation within prior 12 months, due to increased chance of azoospermia
- Developmental delays or other neurological impairment that could impair ability to freely consent, as evaluated by the PI
- Any reason why in the sole judgement of the PI, consent to participate cannot be freely given
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Obtaining 6,000 classified sperm images
Time frame: Each semen sample will be recorded for 10 minutes
Obtaining 6,000 sperm images classified each by at least 2 embryologist based on the WHO 6th edition criteria to add to the AI training of the Baibys system.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2024.
- Individual participant dataSharing planned: Yes. Anonymized patient's data including selection of sperm images/videos will be used together with the clinical study report and protocol will be shared to the medical writer and the supervisor author for the purpose of the the final publication.
Related trials for Sperm Classification
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.
Carter Owen, M.D. principal investigator
CCRM Fertility Clinic and IVF Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sperm Classification, run by BAIBYS Fertility at 1 site 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 5 inclusion and 5 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 23 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 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Obtaining 6,000 classified sperm images (time frame: Each semen sample will be recorded for 10 minutes). 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 23 Jul 2024.