The Use of PulseNmore FC Device in Patients Undergoing IVF Treatment A Study to Evaluate the Safety and the Efficacy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Comparison of device visualization of ovaries and uterus in a sagittal view to ground truth in each visit
研究概览
简要总结
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.
详细描述
- 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.
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 43 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
- •Unable to use the trans-vaginal device.
- •Subjects allergic to the ultrasound probe materials.
- •Significant malposition of the ovaries.
结局指标
主要结局
Comparison of device visualization of ovaries and uterus in a sagittal view to ground truth in each visit
时间窗: 24 months
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)
The incident of device related, or procedure related severe adverse events
时间窗: 24 months
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.
次要结局
- 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)
研究者
YoelShufaro
Head of IVF Unit
Rabin Medical Center