NCT04545918

Convolutional Neural Network in Ovarian Follicle Identification

Assessing a Mask Region-based Convolutional Neural Network in Follicle Identification and Measurement During Ovarian Stimulation

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: Cycle Clarity · Industry
• Sex: Female
• Age: 21 Years – 42 Years
• Healthy volunteers: —

Summary

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.

Detailed description

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.

Conditions

• Infertility, Female
• Ovarian Follicular Cyst

Interventions

Type	Name	Description
DEVICE	Follicle Clarity	Mask Region-based Convolutional Neural Network in Ultrasound Follicle Identification

Timeline

• Start date: 2021-02-01
• Primary completion: 2021-05-10
• Completion: 2021-05-20
• First posted: 2020-09-11
• Last updated: 2021-05-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study