Status:
ACTIVE_NOT_RECRUITING
Sperm Video Recording Protocol
Lead Sponsor:
BAIBYS Fertility
Conditions:
Sperm Classification
Eligibility:
MALE
22+ years
Brief 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 ...
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 e...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
December 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06150846
Start Date
December 1 2023
End Date
August 1 2024
Last Update
July 23 2024
Active Locations (1)
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1
CCRM Northern Virginia
Vienna, Virginia, United States, 22182