Optimizing the Technique of Embryo Transfer in IVF Using Better Imaging Guidance

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.

Study Overview

• Status: Withdrawn
• Conditions: Fertilization in Vitro
• Intervention / Treatment: Device: ultrasound imaging

Detailed Description

Since the first pregnancy using IVF was achieved nearly 40 years ago, many aspects of this procedure have undergone significant progress. In contrast, the technique of embryo transfer (ET) has remained relatively unchanged. A simple yet critical element in the final step of IVF, ET has received little attention. In general, the procedure starts by placing a speculum in the vagina to visualize the cervix, which is cleansed with saline solution or culture media. A transfer catheter is loaded with the embryos is inserted through the cervical canal and advanced into the uterine cavity where the embryos are deposited.

The catheter is then withdrawn and handed to the embryologist, who inspects it for retained embryos. Ultrasound (US) guidance is used to facilitate atraumatic insertion of the catheter, as well as ensure correct location in the uterine cavity.

The available evidence suggests that there is a benefit of using US guidance during ET (Teixeira et al, Ultrasound Obstet Gynecol. 201;45:139-48, Abou-Setta et al, Fertil Steril. 2007;88:333-41).

High quality US imaging is difficult to achieve if the distance from the abdominal wall to the uterus is big (thick abdominal wall, retro-verted uterus), or if the bladder is not full enough.

High resolution US imaging dictates short distance between the US transducer and the organ of interest (in our case cervical canal and endometrium). Previous effort in that direction was done using a vaginal US probe. However, this instrumentation makes the ET technique cumbersome and difficult to perform. We hypothesize that a significant advantage in imaging quality can be achieved by placing a flat or concave high frequency US transducer in the posterior fornix as an extension of the posterior speculum blade.

Our overarching goal is to develop new ET procedure; this procedure will be dependent on precise and high resolution imaging. For that goal we consulted with ultrasound experts that recommended the use of dedicated probe. After a thorough review we found a probe (Philips 21381A / T6207) that is used for pediatric transesophageal applications with operating frequency of 4-7 Megahetz.

As part of the embryo transfer, the investigators plan to insert the above probe into the posterior fornix. The investigators will then evaluate the visualization abilities of placing a probe closer to the uterus. The aim is to define the ultrasound image parameters for ET. The information will be used to define the technical specification for a "tailor made" ET probe.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Haifa, Israel, 31096
    • IVF Unit, Rambam medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria: IVF patients before embryo transfer. -

Exclusion Criteria: IVF patients not willing to participate

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DEVICE_FEASIBILITY
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: IVF patients; 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; Ultrasound imaging during embryo transfer using a small vaginal probe.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Imaging quality	Characterization of exact ultrasound image planes while placing an ultrasound probe within the posterior fornix, for anatomical optimization	About 1 minute

Collaborators and Investigators

• Sponsor: Rambam Health Care Campus

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): May 15, 2017
• Primary Completion (ANTICIPATED): July 1, 2017
• Study Completion (ANTICIPATED): September 1, 2017

Study Registration Dates

• First Submitted: February 13, 2017
• First Submitted That Met QC Criteria: February 20, 2017
• First Posted (ACTUAL): February 23, 2017

Study Record Updates

• Last Update Posted (ACTUAL): October 5, 2017
• Last Update Submitted That Met QC Criteria: October 3, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 0229-16-RMB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No