The Use of PulseNmore FC Device in Patients Undergoing IVF Treatment A Study to Evaluate the Safety and the Efficacy

NCT05485623 | Unknown

• 1 other identifier: 0271-21
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

This is a single center, interventional, longitudinal prospective, of 100 women undergoing fertility treatment in the IVF unit of Belinson Hospital. The study will examine the performance of the FC Clinician-Guided (CG) transvaginal scan done with Pulsenmore FC device, performed by patients with remote guidance of a professional sonographer. Experienced patients who already used the FC device for one cycle in a CG mode, can be re-enrolled for testing also the App-Guided mode of the device. All FC scans will be compared to the conventional ultrasound system in-clinic scan (ground truth - GT). Subjects will participate in the study for one IVF cycle (or 2 cycles if patient is re-enrolled also for the APP mode), an estimated study period of 2 weeks, and scan schedule protocol will follow the standard of care scan schedule for IVF treatment. The last visit will be defined when the attending physician concludes that the follicle requitement potential of the cycle has been achieved and the patient is ready for oocyte aspiration.

Conditions

Women Undergoing Fertility Treatments

Outcome Measures

Primary Outcomes (2)

• The incident of device related, or procedure related severe adverse events

  The incidence of procedure related severe adverse events will be established, using reporting system for each individual subject enrolled in the study. The primary safety endpoint for each study subject is whether there is severe device- or procedure- related adverse events observed during the study. The resulting event rates will be established separately for the video guided and clinician guided modes of the device.

  24 months

• Comparison of device visualization of ovaries and uterus in a sagittal view to ground truth in each visit

  The visualization of the ovaries and uterus in a sagittal view would be matched with the visualization of the ovaries and uterus derived by the ground truth (in-clinic ultrasound scan)

  24 months

Secondary Outcomes (2)

• Comparison of number of follicles >17 mm during the last IVF visit to ground truth

  24 months

• Comparison of endometrium thickness during the last IVF visit to ground truth

  24 months

Study Arms (2)

clinician guided scan comparing the device output to the in clinic scan (ground truth)

EXPERIMENTAL

Naïve subjects who haven't use the FC device will be allocated to use the CG-mode The patient will perform a CG scan, guided by a professional sonographer on a Pulsenmore telehealth platform, who will instruct the patient during the exam. At visit 1: the procedure will be performed in a private room in the clinic, while the clinician will be in a different room than the patient. At visit 2 and all other visits, until the last visit, FC scans will be done from home. The clinician will guide the patient using a standardized language which was practiced and used during the clinician training. By the end of the scan, the patient will transmit the videos to the cloud. Then the clinician will review the video scans for visualization of ovaries and uterus, identifying the number and size of ovarian follicles, endometrial thickness and additional parameters

Device: PulseNmore FC

App guided scan comparing the device output to the in clinic scan (ground truth)

EXPERIMENTAL

Experienced patients who already used the FC device will be offered to use the AG node for a second cycle. The patient will perform self - administered vaginal sonography using the study device and assisted by videos on Pulsenmore app. The procedure will be performed at home, in the morning before the patient come to the clinic for the conventional US and tests. All scans are automatically uploaded to the Pulsenmore web-viewer. A qualified reviewer will review the videos for visualization of ovaries and uterus, identify the number and size of ovarian follicles, and measure endometrial thickness. Other parameters might be evaluated as well. The App guided scan is limited to 4 minutes and the session will be deactivated by the end of the scanning time.

Device: PulseNmore FC

Interventions

PulseNmore FC DEVICE

Pulsenmore Ltd. has developed a small portable vaginal ultrasound device for personal use at home. The ultrasound device allows to scan and assess both the uterus and the ovaries. This ultrasound device connects to a smartphone and a user-friendly application simplifies its use. This ultrasound device is based on the company's 'Pulsenmore ES ultrasound system' which is a small abdominal ultrasound device for home and self-use by pregnant women. This (abdominal) ultrasound device allows scanning and detection of fetal pulse, count fetal movements, assess the amount of amniotic fluid and more. The device is an abdominal ultrasound probe that connects to a smartphone using a specially designed socket. The main difference between the devices is the different design of the ultrasound vaginal probe. The device consists of 2 components: a cradle and an application (software). The cradle contains the electronic components and the ultrasound probe.

App guided scan comparing the device output to the in clinic scan (ground truth); clinician guided scan comparing the device output to the in clinic scan (ground truth)

Eligibility Criteria

• Age: 18 Years - 43 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women undergoing fertility treatments in the IVF unit of Belinson Hospital that require serial transvaginal ultrasound scans.
• Female age 18-43
• Normal pelvic anatomy
• Capable and willing to perform self vaginal ultrasound measurements.
• Ability to understand and sign the informed consent.
• Ability to read and understand instructions that are required for equipment use
• Ability to identify the uterus and ovaries on the device screen by the end of the training session.
• Patient can read and understand Hebrew or English

You may not qualify if:

• Known uterine malformations.
• Known ovarian pathologies.
• Known or suspected diminished ovarian reserve parameters (basal FSH\> 10 IU/L, AFC \<7 or serum AMH \< 1ng/ml), unless 9 or more oocytes were aspirated in a previous ART cycle within the last 3 months.
• Presence of hydrosalpinx.
• Intraabdominal adhesions.
• Previous lower abdominal surgery.
• BMI \>40
• Unable to use the trans-vaginal device.
• Subjects allergic to the ultrasound probe materials.
• Significant malposition of the ovaries.

Sponsors & Collaborators

• Rabin Medical Center: lead
• PulseNmore: collaborator

Study Sites (1)

Rabin Medical Center

Petah Tikva, Israel

RECRUITING

Related Publications (8)

• van den Heuvel JF, Groenhof TK, Veerbeek JH, van Solinge WW, Lely AT, Franx A, Bekker MN. eHealth as the Next-Generation Perinatal Care: An Overview of the Literature. J Med Internet Res. 2018 Jun 5;20(6):e202. doi: 10.2196/jmir.9262.

  PMID: 29871855 RESULT

• Gerris J. Telemonitoring in IVF/ICSI. Curr Opin Obstet Gynecol. 2017 Jun;29(3):160-167. doi: 10.1097/GCO.0000000000000363.

  PMID: 28362680 RESULT

• Kalafat E, Mir I, Perry H, Thilaganathan B, Khalil A. Is home blood-pressure monitoring in hypertensive disorders of pregnancy consistent with clinic recordings? Ultrasound Obstet Gynecol. 2018 Oct;52(4):515-521. doi: 10.1002/uog.19094. Epub 2018 Sep 10.

  PMID: 29786155 RESULT

• Tucker KL, Bankhead C, Hodgkinson J, Roberts N, Stevens R, Heneghan C, Rey E, Lo C, Chandiramani M, Taylor RS, North RA, Khalil A, Marko K, Waugh J, Brown M, Crawford C, Taylor KS, Mackillop L, McManus RJ. How Do Home and Clinic Blood Pressure Readings Compare in Pregnancy? Hypertension. 2018 Sep;72(3):686-694. doi: 10.1161/HYPERTENSIONAHA.118.10917.

  PMID: 30354754 RESULT

• Moy FM, Ray A, Buckley BS, West HM. Techniques of monitoring blood glucose during pregnancy for women with pre-existing diabetes. Cochrane Database Syst Rev. 2017 Jun 11;6(6):CD009613. doi: 10.1002/14651858.CD009613.pub3.

  PMID: 28602020 RESULT

• Raman P, Shepherd E, Dowswell T, Middleton P, Crowther CA. Different methods and settings for glucose monitoring for gestational diabetes during pregnancy. Cochrane Database Syst Rev. 2017 Oct 29;10(10):CD011069. doi: 10.1002/14651858.CD011069.pub2.

  PMID: 29081069 RESULT

• Romano M, Cesarelli M, D'Addio G, Mazzoleni MC, Bifulco P, Ferrara N, Rengo F. Telemedicine fetal phonocardiography surveillance: an italian satisfactory experience. Stud Health Technol Inform. 2010;155:176-81.

  PMID: 20543326 RESULT

• Kovacs F, Torok M, Horvath C, Balogh AT, Zsedrovits T, Nagy A, Hosszu G. A new, phonocardiography-based telemetric fetal home monitoring system. Telemed J E Health. 2010 Oct;16(8):878-82. doi: 10.1089/tmj.2010.0039. Epub 2010 Oct 6.

  PMID: 20925563 RESULT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of IVF Unit

Model Details: Approximately 120 women will be recruited to accommodate 20% drop out. A comparison between FC scan and in-clinic scan (ground truth - GT) will be performed in order to assess the safety, feasibility and efficacy of the Pulsenmore FC device in the two operation modes. Naïve subjects who haven't use the FC device will be allocated to use the CG-mode. While experienced patients who already used the FC device will be offered to use the AG mode for a second cycle.

Study Record Dates

• First Submitted: July 14, 2022
• First Posted: August 3, 2022
• Study Start: December 1, 2022
• Primary Completion: July 30, 2024
• Study Completion: December 30, 2025
• Last Updated: January 9, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)