FAQ

CyEDo you have questions about MyCycleClarity? 

We tackle Frequently Asked Questions below but reach out if you have a different question!

Q: How can I get my clinic started using the Cycle Clarity platform?

A: You can be up and running after completing the 6 steps below.

  1. Schedule a demo with us.
  2. Evaluation of your current ultrasound machines.
  3. Complete business agreements and HIPAA Business Associate agreements.
  4. Set up a virtual machine to run our DICOM server. 
  5. Initiate a virtual training overview session of the platform at least two days prior to onsite training. 
  6. Conduct onsite training. Once onsite, we will have an introductory meeting, set up all the ultrasound machines, and test the system to ensure everything is working properly. Our Integration Specialist will then train ultrasonographers how to perform the ultrasound with MyCycleClarity over the next few full volume patient monitoring days. We will monitor image acquisition quality to ensure images have the proper zoom, brightness and contrast so that AI results are accurate. 

Q: Is MyCycleClarity cost effective? 

A: Use of MyCycleClarity will not only add patient convenience by shortening the time for ultrasounds it will also add significant fertility center savings and increase insurance reimbursement. With the use of MyCycleClarity, ultrasounds can be performed in a fraction of the normal time freeing up time for your physicians and staff. The embryology scheduling function helps the physicians prospectively see embryology workload when making trigger decisions helping to smooth out the volatility of the embryology workload. MyCycleClarity is charged in an all you can scan subscription model. The cost of MyCycleClarity is easily offset by the additional insurance collections with the CPT codes that are available. For more information about pricing feel free to call us at 843-883-6200.

Q: How much does MyCycleClarity cost? 

A: MyCycleClarity has licensing available that is $10 per ultrasound or $535 per physician per month for unlimited ultrasound examinations. The above pricing includes the processing of uterine ultrasound images, the use of LabVue and Cycle Clarity Connections. 

Q: What is Cycle Clarity Connections? 

A: Cycle Clarity Connections is a monitoring network enabled by MyCycleClarity that allows any OB/GYN practice to monitor patients for you at a distance with results of the ovarian and uterine ultrasounds immediately available to you within the MyCycleClarity platform. All images can be reviewed for accuracy and edited if necessary. Results will then be transmitted directly to your EMR. You now have the ability to view the entire ovaries from top to bottom and have full confidence in the ultrasound results for decision making. No chasing down ultrasound results and waiting for faxes. 

Q: Can I charge insurance extra by using MyCycleClarity? 

A: There actually are CPT codes designed for ultrasounds that involve 3D image acquisition with 3D rendering on independent workstations such as MyCycleClarity. Since MyCycleClarity is FDA cleared for use in IVF follicular monitoring we are finding that the CPT codes are frequently reimbursed increasing your center’s insurance reimbursements. These CPT codes generally increase collections by $200 per cycle easily offsetting the cost of MyCycleClarity. 

Q: What ultrasound machines are compatible with MyCycleClarity?

A: MyCycleClarity has been designed to work with most late model, 3D ultrasound machines. More specifically, it can work with any 3D ultrasound machine that can perform a Plane A Cine Sweep. We have validated MyCycleClarity on GE Voluson P, Swift, S and E Series, Philips Epic 5 and Affiniti Series, Samsung V Series and HS Series, Siemens S2000, and Mindray DC-70, and are continuously expanding to more systems.

Q: How long does a 3D ultrasound of the ovary take with MyCycleClarity? 

A: Approximately 10 seconds per ovary. A traditional scan without MyCycleClarity where the ultrasonographer looks for follicles and measures each follicle by hand can take up to 15 minutes depending on the number of follicles that are present. Full results are available in the MyCycleClarity platform in less than a minute enabling decision making in front of the patient.

Q: Can I do uterine ultrasounds with MyCycleClarity? 

A: Yes. MyCycleClarity as the ability to receive 3D uterine ultrasound images to help the clinical team visualize the entire uterine architecture to measure the maximal endometrial thickness and assess for the presence or absence of uterine fibroids, polyps or isthmoceles. SonoHSG ultrasounds can also be sent to MyCycleClarity for examination, measurement and/or sharing with a colleague.

Q: What is the recommended clinical workflow? 

A: Every practice approaches follicular monitoring differently. If your practice prefers to make stimulation decisions at the time of ultrasound, MyCycleClarity results are available in less than a minute after ending the ultrasound exam. With a laptop or tablet in the room the patient can be shown the follicular graphs enabling immediate decision making. With a click of a button those same graphs can be automatically emailed to the patient for future reference. For those practices that wait for decision making until later in the day the results will be transmitted by MyCycleClarity to the EMR for correlation with the hormonal results and callbacks.

Q: What is the accuracy of the system? 

A: The accuracy of the AI analysis is directly related to the quality of the ultrasound images. Clinics with experience using our system report that 1 out of 43 follicles (2.3%) greater than 10 mm in size needed to be added or deleted and that the system is able to adequately assess 93.3% of all patient ultrasounds. The platform experiences difficulties in the case of patients with habitus or anatomic visual obstruction. 

Q: Is MyCycleClarity more accurate than human measurements?

A: MyCycleClarity measurement accuracy is equal to human measurements. MyCycleClarity underwent 5 clinical trials with the “gold standard” being the human measurements. The trials demonstrated equivalence to the human in measurement accuracy. MyCycleClarity, however, performed all of the ultrasounds in 10 seconds per ovary, and measurement accuracy between ultrasonographers using MyCycleClarity was 0.21 mm compared with 2.3 mm with human measurements between ultrasonographers.

Q: How does the embryology scheduling work? 

A: Cycle Clarity uses an AI algorithm that knows each follicle measured on each patient and can calculate the optimal time for oocyte retrieval along with how many eggs will be retrieved, how many are mature, how many will need ICSI, how many develop into blasts, and how many will need to be biopsied on day 5 and 6 of embryo growth. Through this analysis, prospective workload estimates are performed for the embryology lab allowing the physicians to see the lab workload in real time when making “trigger” decisions. This additional information can help the clinical team smooth out the volatility in the embryology lab workload allowing more time for patient care and staff happiness.

Q: How do we get our ultrasound machines to communicate with MyCycleClarity? 

A: Cycle Clarity has developed a proprietary DICOM Server that encrypts the ultrasound images between your ultrasound machine and our cloud-based servers. This DICOM server runs on a virtual machine that your IT team has complete control over. Our engineering team will assist your IT department to set up the virtual machine. This process is fairly routine for IT professionals and takes approximately 30 minutes to complete. 

Q: How long does it take to process the ultrasound video and receive results? 

A: It takes less than 1 minute to return results to the MyCycleClarity portal and your electronic medical record (EMR) allowing you to see the full ultrasound results and counsel patients during the ultrasound examination. 

Q: How long will it take to train our staff to create 3D ultrasounds and send them properly through the system?

A: We recommend onsite training by our Integration Specialists. Ultrasonographers typically have the process mastered within 10 to 20 patient ultrasounds.

Q: Will Cycle Clarity require post processing once the ultrasound scan is complete?

A: In the early stages of adopting Cycle Clarity into your practice, we strongly recommend post processing. Reviewing images in the early stages allows your practice to get comfortable with creating an image optimal for Cycle Clarity to read and measure. Post processing should only take 1-2 minutes per patient.

Q: What is the “uptime” of MyCycleClarity?

A: MyCycleClarity runs within the Microsoft Azure Cloud Network. Uptime for the servers is over 99.9%. We chose the Azure network due to its robust security and redundancy. In our experience, downtime in most cases is related to internet connectivity issues. We recommend you confirm the MyCycleClarity results before the patient leaves your office. Full results are typically available within 5 minutes of completing the ultrasound. All images are stored on your local ultrasound machines.

Q: How long will the data be stored and accessible on MyCycleClarity? 

A: Medical Imaging Record Retention policy varies from state to state. Medicare and most states require retaining images for 5 years. Cycle Clarity will retain all images we process for 5 years. After that you may pay for additional storage or at no charge we will provide your clinic with a link to your images if you choose to download them and store them in a different location. 

Q: If I want the MyCycleClarity results sent directly to my electronic medical record (EMR) does my EMR company need to add programming? What data will the EMR receive?

A: As long as your EMR currently accepts follicle measurement results from your ultrasound machines, then MyCycleClarity can transmit the results to your EMR without any additional EMR programming. Only the follicle measurement data will be transmitted to the EMR, not the videos. The ultrasound videos can be viewed on the MyCycleClarity platform.

Q: How does MyCycleClarity compare to other automated follicular measurement tools embedded within ultrasound machines? 

A: MyCycleClarity’s clinical trial that was submitted to the FDA showed that we are statistically superior to SonoAVC in terms of measurement accuracy and number of follicles within the ovary and equivalent to the industry gold standard, the human. 

Q: Can MyCycleClarity tell the difference between a follicle and an endometrioma or corpus luteum? 

A: Yes, MyCycleClarity is trained to detect hypoechoic structures within the ovary. Cysts with complex or hyperechoic structures are typically not included in the follicular measurements. 

Q: Can Cycle Clarity hold images other than videos of the ovary?

A: Yes, Cycle Clarity can establish communication between your HSG machine and our platform allowing for the transmission of all of your HSG images. With this approach you can search for and view, download and print all of your HSG images on the Cycle Clarity platform. There will be a tab in your center’s MyCycleClarity portal that will hold each patient’s images for 7 years. 

Q: What patients can’t have Follicle Clarity imaging?

A: Patients with difficult to visualize ovaries due to habitus and other anatomic visualization challenges are best assessed through human measurements. In clinical practice MyCycleClarity can be used in 90 to 95% of all patients. 

Q: Is Follicle Clarity FDA cleared?

A: Yes, Follicle Clarity has been cleared by US FDA per K212012, 510(k).

Q: Do patients have access to Cycle Clarity results?

A: Patients can have their Cycle Clarity results emailed to them if the center chooses. We feel this is a big benefit to Cycle Clarity as the patients love to know their follicular measurements and will receive their follicle counts in graphic and tabular form via a mobile friendly email. This approach helps to save the nursing time typically spent explaining the follicular ultrasound results. In addition, there is a two minute video explaining to the patient what Cycle Clarity is and why you chose the platform to enhance patient care.

 

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We are a team of physicians, embryologists, computer engineers, data scientists, ultrasonographers, image annotators and biostatisticians dedicated to improving the world of fertility treatment through the application of cognitive computing in healthcare.

Cycle Clarity - P.O. Box 2204 -Mount Pleasant, SC, 29465, US
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