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

Primary Purpose

Infertility

Status
Terminated
Phase
Early Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Transvaginal ultrasound-guided embryo transfer
Transabdominal ultrasound-guided embryo transfer
Sponsored by
IVI Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility focused on measuring Female infertility, Oocyte donation, Embryo transfer, Transvaginal ultrasonography, Transabdominal ultrasonography

Eligibility Criteria

18 Years - 49 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • IVI Madrid

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Transvaginal ultrasound-guided embryo transfer

Transabdominal ultrasound-guided embryo transfer

Arm Description

Transvaginal ultrasound-guided transfer of two day-3 embryos

Transabdominal ultrasound-guided transfer of two day-3 embryos

Outcomes

Primary Outcome Measures

Pregnancy rate
Proportion of patients with a positive pregnancy test

Secondary Outcome Measures

Clinical pregnancy rate
Proportion of patients with at least one gestational sac at first pregnancy ultrasound
Ongoing pregnancy rate
Proportion of patients with at least one live intrauterine fetus at 10 weeks post-embryo transfer
Menstruation-like pain
Measured on a three-level scale (none/mild/strong)
Discomfort related to vesical distension
Measured on a three-level scale (none/mild/strong)
Overall discomfort
Measured on a three-level scale (none/mild/strong)
Difficulty using the assigned technique faced by operators
Measured on a three-level scale (easy/moderately difficult/very difficult)
Catheterization time
Conversion to the opposite technique
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)

Full Information

First Posted
March 1, 2013
Last Updated
March 5, 2017
Sponsor
IVI Madrid
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1. Study Identification

Unique Protocol Identification Number
NCT01805505
Brief Title
Comparison of Embryo Transfer in Egg Donation Recipients With Transvaginal and Transabdominal Ultrasound
Official Title
Comparison of Embryo Transfer in Egg Donation Recipients With Transvaginal and Transabdominal Ultrasound
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Why Stopped
slow recruitment rate
Study Start Date
February 2012 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IVI Madrid

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Female infertility, Oocyte donation, Embryo transfer, Transvaginal ultrasonography, Transabdominal ultrasonography

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
346 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Transvaginal ultrasound-guided embryo transfer
Arm Type
Experimental
Arm Description
Transvaginal ultrasound-guided transfer of two day-3 embryos
Arm Title
Transabdominal ultrasound-guided embryo transfer
Arm Type
Active Comparator
Arm Description
Transabdominal ultrasound-guided transfer of two day-3 embryos
Intervention Type
Procedure
Intervention Name(s)
Transvaginal ultrasound-guided embryo transfer
Other Intervention Name(s)
Kitazato Long ET catheter (Kitazato Medical Co. Ltd., Tokyo, Japan)
Intervention Description
Embryo transfer of two day-3 embryos performed with the Kitazato Long ET catheter (Kitazato Medical Co. Ltd., Tokyo, Japan), guided by transvaginal ultrasound
Intervention Type
Procedure
Intervention Name(s)
Transabdominal ultrasound-guided embryo transfer
Other Intervention Name(s)
Cook Soft-Trans ET catheter (Cook Medical Inc., Bloomington, IN, USA)
Intervention Description
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
Primary Outcome Measure Information:
Title
Pregnancy rate
Description
Proportion of patients with a positive pregnancy test
Time Frame
At performing the pregnancy test 11 days post-embryo transfer
Secondary Outcome Measure Information:
Title
Clinical pregnancy rate
Description
Proportion of patients with at least one gestational sac at first pregnancy ultrasound
Time Frame
At first pregnancy ultrasound (3 weeks post-embryo transfer)
Title
Ongoing pregnancy rate
Description
Proportion of patients with at least one live intrauterine fetus at 10 weeks post-embryo transfer
Time Frame
At 10 weeks post-embryo transfer
Title
Menstruation-like pain
Description
Measured on a three-level scale (none/mild/strong)
Time Frame
At embryo transfer
Title
Discomfort related to vesical distension
Description
Measured on a three-level scale (none/mild/strong)
Time Frame
At embryo transfer
Title
Overall discomfort
Description
Measured on a three-level scale (none/mild/strong)
Time Frame
At embryo transfer
Title
Difficulty using the assigned technique faced by operators
Description
Measured on a three-level scale (easy/moderately difficult/very difficult)
Time Frame
At embryo transfer
Title
Catheterization time
Time Frame
At embryo transfer
Title
Conversion to the opposite technique
Description
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)
Time Frame
At embryo transfer

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erik E Hauzman, MD, PhD
Organizational Affiliation
IVI Madrid
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Juan A Garcia-Velasco, MD, PhD
Organizational Affiliation
IVI Madrid
Official's Role
Study Director
Facility Information:
Facility Name
IVI Madrid
City
Madrid
ZIP/Postal Code
28023
Country
Spain

12. IPD Sharing Statement

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

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