NCT03062098

Brief Summary

This trial seeks to improve ultrasound imaging during embryo transfer in IVF by using a small, high resolution ultrasound probe used routinely for cardiac imaging in children.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 23, 2017

Completed
3 months until next milestone

Study Start

First participant enrolled

May 15, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

October 5, 2017

Status Verified

October 1, 2017

Enrollment Period

2 months

First QC Date

February 13, 2017

Last Update Submit

October 3, 2017

Conditions

Fertilization in Vitro

Outcome Measures

Primary Outcomes (1)

  • Imaging quality

    Characterization of exact ultrasound image planes while placing an ultrasound probe within the posterior fornix, for anatomical optimization

    About 1 minute

Study Arms (1)

IVF patients

EXPERIMENTAL

IVF patients before embryo transfer. Before performing embryo transfer in the routine manner, ten patients will be asked to participate in the study. After signing informed consent, participants will undergo the experimental procedure: Speculum will be placed to visualize the cervix. The thin ultrasound probe will be places posterior to the cervix. While viewing the image on the ultrasound screen, the probe will be moved manually to obtain the best imaging of the cervical canal. An empty embryo transfer catheter will be introduced to the cervical canal and will be advanced under ultrasound imaging up to the internal os. The catheter will be withdrawn, and routine embryo transfer will follow.

Device: ultrasound imaging

Interventions

ultrasound imagingDEVICE

Ultrasound imaging during embryo transfer using a small vaginal probe.

IVF patients

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsIVF patients - all females
Healthy VolunteersNo
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IVF Unit, Rambam medical Center

Haifa, 31096, Israel

Location

MeSH Terms

Interventions

Ultrasonography

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 13, 2017

First Posted

February 23, 2017

Study Start

May 15, 2017

Primary Completion

July 1, 2017

Study Completion

September 1, 2017

Last Updated

October 5, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)