Convolutional Neural Network in Ovarian Follicle Identification

• Conditions: Infertility, Female; Ovarian Follicular Cyst
• Interventions: Device: Follicle Clarity

• Registration Number: NCT04545918
• Lead Sponsor: Cycle Clarity

Brief 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.

Study Timeline

• Study First Submitted: 2020-09-04
• Study First Submitted QC: 2020-09-04
• Study First Posted: 2020-09-11
• Study Start: 2021-02-01
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-05
• Last Update Posted: 2021-05-07
• Primary Completion: 2021-05-10
• Study Completion: 2021-05-20

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Infertile Female	Follicle Clarity	90 female patients with infertility undergoing an ovarian stimulation with use of exogenous gonadotropins.

Primary Outcome Measures

Name	Time	Method
Median size (mm) of ovarian follicles in CCAI compared to SonoAVC	1 month	Comparison of the mean size in mm of Cycle Clarity's Artificial Intelligence software (CCAI) compared with GE SonoAVC

Secondary Outcome Measures

Name	Time	Method
Number of ovarian follicles in CCAI compared to Sono	1 month	Comparison of the number of ovarian follicles with Cycle Clarity's Artificial Intelligence software (CCAI) compared with GE SonoAVC

Trial Locations

Locations (1)

Coastal Fertility Specialists; 🇺🇸 Mount Pleasant, South Carolina, United States