Recruiting

Observational Study

Sponsor:

Cycle Clarity

Code:

NCT04545918

Conditions

Infertility, Female

Ovarian Follicular Cyst

Eligibility Criteria

Sex: Female

Age: 21 - 42

Healthy Volunteers: Not accepted

Interventions

Follicle Clarity

Study Details

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.

Conditions

Infertility, Female

Ovarian Follicular Cyst

Study ID

NCT04545918

Start date

Feb 1, 2021

Status verified date

May, 2021

Completion date

May 20, 2021

Anticipated

Primary completion date

May 10, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 21 - 42

Healthy Volunteers: Not accepted

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

Enrollment

80 participants

Anticipated

Interventions and Outcome Measures

Arms

Infertile Female

90 female patients with infertility undergoing an ovarian stimulation with use of exogenous gonadotropins.

Interventions

Follicle Clarity

Mask Region-based Convolutional Neural Network in Ultrasound Follicle Identification

Primary outcome measure

  • Median size (mm) of ovarian follicles in CCAI compared to SonoAVC [ Time Frame: 1 month ]

Central Contacts and Locations

Central contacts

John A Schnorr, MD

843-883-6200john.schnorr@cycleclarity.com

Susan R. Schnorr

843-883-6200susan.schnorr@cycleclarity.com

Locations

Coastal Fertility Specialists

Recruiting

Mount Pleasant, South Carolina, United States, 29464

Contacts

Michael J Slowey

843-883-5800michael.slowey@coastalfertility.us

Heather Cook, MD

8438835800heather.cook@coastalfertility.us

Principal Investigator:

Michael J Slowey, MD

More Information

Sponsor

Cycle Clarity

Last update posted

May 7, 2021

Last verified

May, 2021

Keywords

  • Infertility
  • Ovarian Follicle

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Cycle Clarity on 2021-05-07.