Using a new device to assist women undergoing IVF treatment
The Use of PulseNmore FC Device in Patients Undergoing IVF Treatment A Study to Evaluate the Safety and the Efficacy
NA · Rabin Medical Center · NCT05485623
This study tests a new device that helps women undergoing IVF by allowing them to do self-scans with guidance from a sonographer to see if it's as good as regular ultrasound machines.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 43 Years |
| Sex | Female |
| Sponsor | Rabin Medical Center (other) |
| Locations | 1 site (Petach Tikva) |
| Trial ID | NCT05485623 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of the PulseNmore FC device in women undergoing fertility treatments at Belinson Hospital. It involves 100 participants who will perform self-transvaginal scans with remote guidance from a professional sonographer. The study compares the results of these scans to conventional ultrasound systems to assess the device's performance. Participants may be involved for one or two IVF cycles, depending on their previous experience with the device.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-43 undergoing fertility treatments who can perform self-scans and have normal pelvic anatomy.
Not a fit: Patients with known uterine malformations, ovarian pathologies, or those unable to use the trans-vaginal device may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accessibility and effectiveness of fertility monitoring for women undergoing IVF.
How similar studies have performed: While the approach of using remote guidance for self-scanning is innovative, similar studies have shown promise in enhancing patient autonomy in fertility treatments.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Petach Tikva
- Rabin Medical Center — Petach Tikva, Israel (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Women Undergoing Fertility Treatments