Infertility, FemaleNCT04545918
Convolutional Neural Network in Ovarian Follicle Identification
An observational study of Infertility, Female and Ovarian Follicular Cyst, run by Cycle Clarity at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 21 to 42 years, women only
- Conditions the study is for
- Infertility, Female, Ovarian Follicular Cyst
- What is being tested?
- Follicle Clarity
- Type of treatment
- Medical device
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2021to 20 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 42 years
- Women only
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Coastal Fertility Specialists
Mt. Pleasant, South Carolina, 29464
Michael J Slowey, 843-883-5800, michael.slowey@coastalfertility.us
Heather Cook, MD, 8438835800, heather.cook@coastalfertility.us
About this study
Official title: 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.
Read the 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
- Being tested
- Follicle Clarity
- Keywords
- Infertility, Ovarian Follicle
- Medical subject headings
- Infertility, Female, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Follicle ClarityDevice
Mask Region-based Convolutional Neural Network in Ultrasound Follicle Identification
| Study group | Role | What they receive |
|---|---|---|
| Infertile Female | 90 female patients with infertility undergoing an ovarian stimulation with use of exogenous gonadotropins. Receives: Device: Follicle Clarity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 month
Secondary outcomes (1)
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
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2020
- Study start1 Feb 2021
- Primary completion10 May 2021 (estimated)
- Study completion20 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Infertility, FemaleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cycle Clarity
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- John A. Schnorr, MD, Study chair, Cycle Clarity, Founder
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04545918
- Sponsor's protocol ID
- CC2020-001
- Status last verified
- May 2021
- First submitted
- 4 Sep 2020
- Last updated
- 7 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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.
PubMed 27126581Gordon 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.
PubMed 2058957
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing a Mask Region-based Convolutional Neural Network in Follicle Identification and Measurement During Ovarian Stimulation
- ClinicalTrials.gov ID
- NCT04545918
- Acronym / sponsor ID
- CC2020-001
- Conditions
- Infertility, Female, Ovarian Follicular Cyst
- Keywords
- Infertility, Ovarian Follicle
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Cycle ClarityIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 10 May 2021 (estimated)
- Study completion
- 20 May 2021 (estimated)
- First posted
- 11 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infertile Female | – | Device: Follicle Clarity90 female patients with infertility undergoing an ovarian stimulation with use of exogenous gonadotropins. |
Who may qualify
- Ages
- 21 to 42 years
- Sex
- Female only
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Follicle ClarityMask Region-based Convolutional Neural Network in Ultrasound Follicle Identification | Device | Infertile Female |
Primary outcome
Median size (mm) of ovarian follicles in CCAI compared to SonoAVC
Time frame: 1 month
Comparison of the mean size in mm of Cycle Clarity's Artificial Intelligence software (CCAI) compared with GE SonoAVC
1 secondary outcome
Number of ovarian follicles in CCAI compared to Sono
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2021.
- Background: PubMed 27126581Al-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.
- Background: PubMed 2058957Gordon 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John A. Schnorr, MD study chair
Cycle Clarity, Founder
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility, Female and Ovarian Follicular Cyst, run by Cycle Clarity at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact John A Schnorr, MD (843-883-6200, john.schnorr@cycleclarity.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median size (mm) of ovarian follicles in CCAI compared to SonoAVC (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04545918, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2021.