Ultrasound Guidance for Embryo Transfer

March 11, 2019 updated by: Haitham Aboali Hamza, Menoufia University

Transvaginal Versus Transabdominal Ultrasound Guided Embryo Transfer. Randomized Controlled Trial.

Randomized controlled study comparing the TVUS versus TAUS guidance during the procedure of embryo transfer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of this study was to Compare between transvaginal and transabdominal ultrasound guided embryo transfer as regarding clinical pregnancy rate, patient comfort, time required for embryo transfer and endometrial visualization at time of embryo transfer.

Study Type

Interventional

Enrollment (Actual)

178

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt, 94109
        • Alexandria University
    • Monofiya
      • Shibīn Al Kawm, Monofiya, Egypt, 32511
        • Menoufia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 42 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

All patients undergoing autologous ICSI and frozen embryo transfer (FET) cycles.

Exclusion Criteria:

  1. Cases of sever ovarian hyperstimulation requiring embryo cryopreservation
  2. Gestational surrogate cycles
  3. Oocyte donation cycles
  4. Very poor responders
  5. Patients with inadequate visualization of the uterus by ultrasound.
  6. Very difficult mock embryo transfer.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transvaginal Ultrasound Guided ET
Transvaginal ultrasound is used to guide ET
Procedure: Transvaginal Ultrasound Guided ET
Use of TVUS to guide ET
Other Names:
  • Transvaginal US guided ET
Experimental: Transabdominal Ultrasound Guided ET
Transabdominal ultrasound is used to guide ET
Procedure: Transabdominal Ultrasound Guided ET
Use of TAUS to guide ET
Other Names:
  • Transabdominal US guided ET

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical pregnancy
Time Frame: 3 weeks after Embryo transfer
A clinical pregnancy is a pregnancy that is confirmed by ultrasonic visualization of gestational sac or heartbeat.
3 weeks after Embryo transfer

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time required for ET
Time Frame: Time from when the catheter is handed to the transferring physician to the time it is returned to the transferring embryologist.
Time in seconds required for ET
Time from when the catheter is handed to the transferring physician to the time it is returned to the transferring embryologist.
Degree of cramping and pain
Time Frame: During and immediately after ET
Degree of cramping and pain from 0 to 10 by visual analogue scale (VAS) where 0 is no pain and 10 unbearable pain.
During and immediately after ET
Endometrial visualization at time of embryo transfer
Time Frame: During ET
Endometrial visualization at time of embryo transfer by ultrasound
During ET

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Menoufia University

Collaborators

Alexandria University

Investigators

  • Study Chair: Mohamad S kandil, MD, Menoufia University
  • Study Director: Sherif S Gaafar, MD, Alexandria University
  • Principal Investigator: Haitham A Hamza, MD, Menoufia University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 2, 2016

Primary Completion (Actual)

February 15, 2019

Study Completion (Actual)

March 9, 2019

Study Registration Dates

First Submitted

February 5, 2019

First Submitted That Met QC Criteria

February 21, 2019

First Posted (Actual)

February 22, 2019

Study Record Updates

Last Update Posted (Actual)

March 12, 2019

Last Update Submitted That Met QC Criteria

March 11, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MU179

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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