Clinical trial NCT05485623: The Use of PulseNmore FC Device in Patients Undergoing IVF Treatment A Study to Evaluate the Safety and the Efficacy
Official title: The Use of PulseNmore FC Device in Patients Undergoing IVF Treatment A Study to Evaluate the Safety and the Efficacy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Women Undergoing Fertility Treatments
Lead sponsor: Rabin Medical Center
Sponsor class: OTHER
Collaborators: name: PulseNmore
First posted: 2022-08-03
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: 1. 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.
2. Primary Effectiveness Endpoints. The study will examine the performance of the clinician guided modes of the device. This shall be utilizing various parameters in acquired images/clips utilizing the Pulsenmore FC system, "the candidate device", in the:

Clinician guided mode- the self-transvaginal scan is performed by the patient with the remote guidance of a professional sonographer.

Comparing them to the conventional ultrasound system in clinical settings (ground truth - GT) in terms of visualization of the ovaries and uterus. The study will be considered successful for video guided and clinician guided separately, based on the concordance level of visualization of the ovaries and uterus when compared to GT in each visit and at the last visit.

Study target population: 100 women ages 18-43 undergoing ovarian stimulation in the IVF unit of Belinson Hospital.

For CG mode evaluation - naive subjects, who have never used the FC device. For AG mode evaluation - Subjects who participate in the study and have already used the FC device in a CG mode for one cycle.

Study Design Summary: This is a single centre, longitudinal investigational prospective study, of 100 women undergoing fertility treatment in the IVF unit of Belinson Hospital. 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.

Study subjects will each perform a total of 5-6 ultrasound visits. The number of visits will be determined by the treating physician according to the IVF cycle progression.

Subject will undergo screening and Inform consent process. Then, patient will receive FC device and phone to be used during the study. The training and qualification will be done via the CG mode, with the goal to confirm the patient's physical suitability, capability and willing to participate the study.

Following training, patient will undergo her first US sessions: first the CG scan and then the in-clinic scan. Only at visit 1 both scanning sessions will be performed at the clinic by the clinic' sonographer. Then, the patient will take the FC device \& phone to be used at home at the next visits.

Each visit constituting of 2 different scans (CG or AG and in-clinic scan). During the ART cycle, the scan schedule protocol will follow the standard of care scan schedule for ovary stimulation treatment.

FC scans will be done remotely, at the patient's home in the morning. The FC sessions will be done at the same day and before the in-clinic visit. CG scan will be guided by an external sonographer. AG scan will be done by the patient with no guidance. The in-clinic US session will be performed in the clinic at the same morning, by the clinic's sonographer, no later than 3 hours after the CG session.

The last study visit is the visit before trigger and before Ovary Pick-UP (OPU). The patient will return the device and phone when she comes to the clinic for the OPU procedure.

Following completion of the last visit, patient and sonographer will receive an online questionnaire for evaluation their satisfaction and user experience as well as the subject capability to use AG mode in the next cycle, if relevant.

Before the enrolment of the 100 patients begins, a pilot study of 4 patients, 2 in each application mode which will follow the same protocol will be enrolled. The purpose of the pilot is to streamline the procedure. They will be included in the safety outcome of the study but will not be part of the effectiveness determination of the product. The enrolment of the 100 patients will begin after the 4 initial patients were completed.

Scans reading and interpretation:

All results from the App guided scan/ clinician guided scan and in-clinic scans will be stored and compared. If any discordant data is found, additional independent reviewer, acquired by the company will read the scans in question. The in-clinic scan will be used as the gold standard. The independent reviewers should be blinded to the in-clinic scan and to the previous device output scans. Majority rule (two of three) will be used to establish the correct reading of any of the discordant parameters in the video guided and clinician guided modes.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: The incident of device related, or procedure related severe adverse events
timeFrame: 24 months
measure: Comparison of device visualization of ovaries and uterus in a sagittal view to ground truth in each visit
timeFrame: 24 months
Secondary outcomes:
measure: Comparison of number of follicles >17 mm during the last IVF visit to ground truth
timeFrame: 24 months
measure: Comparison of endometrium thickness during the last IVF visit to ground truth
timeFrame: 24 months
Other outcomes:
Locations:
city: Petach Tikva
country: Israel
facility: Rabin Medical Center
Study officials:
References:
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