Assessing a Mask Region-based Convolutional Neural Network in Follicle Identification and Measurement During Ovarian Stimulation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Median size (mm) of ovarian follicles in CCAI compared to SonoAVC
研究概览
简要总结
A prospective cohort trial studying patients with infertility undergoing an ovarian stimulation with exogenous gonadotropins. Ovarian monitoring will be performed with a combination of transvaginal ultrasound and 2 dimensional human measurements of the follicle development on the right and left ovaries along with SonoAVC. Human and SonoAVC measurements will then be compared to mask region-based convolutional neural network in follicle identification and measurement during during the ovarian stimulation.
详细描述
This is a prospective cohort trial in which a total of 80 female subjects with infertility between the ages of 21 and 42 years of age undergoing ovarian stimulation will be recruited. After giving informed written consent the subject to undergo standard ovarian ultrasound monitoring with transvaginal ultrasounds during the ovarian stimulation. Monitoring will be performed with two-dimensional measurements of each follicle greater than 10 mm in size by the ultrasonographer. SonoAVC will then be applied to both ovaries for automated counting and measurement of the follicles within the ovaries. The patient will then undergo two 6-second ultrasounds of the right and left ovaries which will then be transmitted in a DICOM format to mask regional based recurrent neural network which is been trained and validated for follicle detection and quantification using curated transvaginal ultrasound images.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 42 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Infertile women ages 21-42 years old undergoing ovarian hyperstimulation as part of the treatment care.
- •Women with at least one ovary visible with transvaginal ultrasound. Women with at least one follicle 10 mm or greater in average diameter.
排除标准
- •Women less than 21 years of age or greater than 42 years of age. Women without a visible ovary by transvaginal ultrasound. Women without a follicle at least 10 mm in average diameter
结局指标
主要结局
Median size (mm) of ovarian follicles in CCAI compared to SonoAVC
时间窗: 1 month
Comparison of the mean size in mm of Cycle Clarity's Artificial Intelligence software (CCAI) compared with GE SonoAVC
次要结局
- Number of ovarian follicles in CCAI compared to Sono(1 month)