Convolutional Neural Network in Ovarian Follicle Identification

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

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.

Study Overview

• Status: Recruiting
• Conditions: Infertility, Female; Ovarian Follicular Cyst
• Intervention / Treatment: Device: Follicle Clarity

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 Type: Observational
• Enrollment (Anticipated): 80

Contacts and Locations

• Study Contact: Name: John A Schnorr, MD; Phone Number: 843-883-6200; Email: john.schnorr@cycleclarity.com
• Study Contact Backup: Name: Susan R. Schnorr; Phone Number: 843-883-6200; Email: susan.schnorr@cycleclarity.com

Study Locations

• United States
  • South Carolina
    • Mount Pleasant, South Carolina, United States, 29464
      • Recruiting
      • Coastal Fertility Specialists
      • Contact: Michael J Slowey; Phone Number: 843-883-5800; Email: michael.slowey@coastalfertility.us
      • Contact: Heather Cook, MD; Phone Number: 8438835800; Email: heather.cook@coastalfertility.us
      • Principal Investigator: Michael J Slowey, MD
      • Sub-Investigator: Heather M Cook, MD
      • Sub-Investigator: Jessica McLaughlin, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 42 years (ADULT)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Eighty (80) consecutive female subjects of any race, 21 - 42 years of age meeting the inclusion criteria will be enrolled in the study conducted at one of 4 Coastal Fertility Specialists fertility clinics located in South Carolina and Georgia, USA.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Infertile Female; 90 female patients with infertility undergoing an ovarian stimulation with use of exogenous gonadotropins.	Device: Follicle Clarity; Mask Region-based Convolutional Neural Network in Ultrasound Follicle Identification

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cycle Clarity
• Investigators: Study Chair: John A. Schnorr, MD, Cycle Clarity, Founder

Publications and helpful links

General Publications

• Al-Inany HG, Youssef MA, Ayeleke RO, Brown J, Lam WS, Broekmans FJ. Gonadotrophin-releasing hormone antagonists for assisted reproductive technology. Cochrane Database Syst Rev. 2016 Apr 29;4(4):CD001750. doi: 10.1002/14651858.CD001750.pub4.
• Gordon K, Hodgen GD. GnRH analogues in ovarian stimulation. Ann N Y Acad Sci. 1991;626:238-49. doi: 10.1111/j.1749-6632.1991.tb37919.x. No abstract available.

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 1, 2021
• Primary Completion (ANTICIPATED): May 10, 2021
• Study Completion (ANTICIPATED): May 20, 2021

Study Registration Dates

• First Submitted: September 4, 2020
• First Submitted That Met QC Criteria: September 4, 2020
• First Posted (ACTUAL): September 11, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 7, 2021
• Last Update Submitted That Met QC Criteria: May 5, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Infertility; Ovarian Follicle
• Additional Relevant MeSH Terms: Neoplasms; Cysts; Infertility; Infertility, Female; Follicular Cyst
• Other Study ID Numbers: CC2020-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No