Comparison of Embryo Transfer in Egg Donation Recipients With Transvaginal and Transabdominal Ultrasound

March 5, 2017 updated by: IVI Madrid
Transabdominal ultrasound guidance is the golden standard for embryo transfers. Transvaginal ultrasound guidance was proposed recently to provide better visualization and reduce patient discomfort as embryo transfer can be performed with an empty bladder in this case. The purpose of this study is to determine whether there are any differences between transvaginal and transabdominal ultrasound-guided embryo transfer in terms of ease of use, patient satisfaction, and treatment outcome.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

346

Phase

  • Early Phase 1

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

  • Spain
      • Madrid, Spain, 28023
        • IVI Madrid

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

18 years to 49 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients undergoing oocyte donation treatment with transfer of 2 embryos on day 3

Exclusion Criteria:

  • Submucous or >3 cm intramural fibroids
  • Turner syndrome
  • Black recipients

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: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Transvaginal ultrasound-guided embryo transfer
Transvaginal ultrasound-guided transfer of two day-3 embryos
Procedure: Transvaginal ultrasound-guided embryo transfer
Embryo transfer of two day-3 embryos performed with the Kitazato Long ET catheter (Kitazato Medical Co. Ltd., Tokyo, Japan), guided by transvaginal ultrasound
Other Names:
  • Kitazato Long ET catheter (Kitazato Medical Co. Ltd., Tokyo, Japan)
Active Comparator: Transabdominal ultrasound-guided embryo transfer
Transabdominal ultrasound-guided transfer of two day-3 embryos
Procedure: Transabdominal ultrasound-guided embryo transfer
Embryo transfer of two day-3 embryos performed with the Cook Soft-Trans ET catheter (Cook Medical Inc., Bloomington, IN, USA), guided by transabdominal ultrasound
Other Names:
  • Cook Soft-Trans ET catheter (Cook Medical Inc., Bloomington, IN, USA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pregnancy rate
Time Frame: At performing the pregnancy test 11 days post-embryo transfer
Proportion of patients with a positive pregnancy test
At performing the pregnancy test 11 days post-embryo transfer

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical pregnancy rate
Time Frame: At first pregnancy ultrasound (3 weeks post-embryo transfer)
Proportion of patients with at least one gestational sac at first pregnancy ultrasound
At first pregnancy ultrasound (3 weeks post-embryo transfer)
Ongoing pregnancy rate
Time Frame: At 10 weeks post-embryo transfer
Proportion of patients with at least one live intrauterine fetus at 10 weeks post-embryo transfer
At 10 weeks post-embryo transfer
Menstruation-like pain
Time Frame: At embryo transfer
Measured on a three-level scale (none/mild/strong)
At embryo transfer
Discomfort related to vesical distension
Time Frame: At embryo transfer
Measured on a three-level scale (none/mild/strong)
At embryo transfer
Overall discomfort
Time Frame: At embryo transfer
Measured on a three-level scale (none/mild/strong)
At embryo transfer
Difficulty using the assigned technique faced by operators
Time Frame: At embryo transfer
Measured on a three-level scale (easy/moderately difficult/very difficult)
At embryo transfer
Catheterization time
Time Frame: At embryo transfer
At embryo transfer
Conversion to the opposite technique
Time Frame: At embryo transfer
Proportion of cases in which embryo transfer was performed using the technique of the opposite randomization arm (i.e., proportion of patients randomized to have transabdominal ultrasound-guided transfer in whom transvaginal ultrasound-guided was performed, and the other way around)
At embryo transfer

Collaborators and Investigators

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

Sponsor

IVI Madrid

Investigators

  • Study Director: Juan A Garcia-Velasco, MD, PhD, IVI Madrid
  • Principal Investigator: Erik E Hauzman, MD, PhD, IVI Madrid

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

February 1, 2012

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

March 1, 2013

First Submitted That Met QC Criteria

March 4, 2013

First Posted (Estimate)

March 6, 2013

Study Record Updates

Last Update Posted (Actual)

March 7, 2017

Last Update Submitted That Met QC Criteria

March 5, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MAD-EH-01-2012-01

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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