Sperm Video Recording Protocol
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Obtaining 6,000 classified sperm images
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Obtaining 6,000 classified sperm images
时间窗: 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.
次要结局
未报告次要终点