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

This study is currently recruiting participants.
Verified March 2013 by IVI Madrid
Sponsor:
Information provided by (Responsible Party):
IVI Madrid
ClinicalTrials.gov Identifier:
NCT01805505
First received: March 1, 2013
Last updated: March 4, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention
Infertility
 Procedure: Transvaginal ultrasound-guided embryo transfer
Procedure: Transabdominal ultrasound-guided embryo transfer

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Embryo Transfer in Egg Donation Recipients With Transvaginal and Transabdominal Ultrasound

Resource links provided by NLM:

MedlinePlus related topics: Infertility
U.S. FDA Resources

Further study details as provided by IVI Madrid:

Primary Outcome Measures:
  • Pregnancy rate [ Time Frame: At performing the pregnancy test 11 days post-embryo transfer ] [ Designated as safety issue: No ]
    Proportion of patients with a positive pregnancy test


Secondary Outcome Measures:
  • Clinical pregnancy rate [ Time Frame: At first pregnancy ultrasound (3 weeks post-embryo transfer) ] [ Designated as safety issue: No ]
    Proportion of patients with at least one gestational sac at first pregnancy ultrasound

  • Ongoing pregnancy rate [ Time Frame: At 10 weeks post-embryo transfer ] [ Designated as safety issue: No ]
    Proportion of patients with at least one live intrauterine fetus at 10 weeks post-embryo transfer

  • Menstruation-like pain [ Time Frame: At embryo transfer ] [ Designated as safety issue: No ]
    Measured on a three-level scale (none/mild/strong)

  • Discomfort related to vesical distension [ Time Frame: At embryo transfer ] [ Designated as safety issue: No ]
    Measured on a three-level scale (none/mild/strong)

  • Overall discomfort [ Time Frame: At embryo transfer ] [ Designated as safety issue: No ]
    Measured on a three-level scale (none/mild/strong)

  • Difficulty using the assigned technique faced by operators [ Time Frame: At embryo transfer ] [ Designated as safety issue: No ]
    Measured on a three-level scale (easy/moderately difficult/very difficult)

  • Catheterization time [ Time Frame: At embryo transfer ] [ Designated as safety issue: No ]
  • Conversion to the opposite technique [ Time Frame: At embryo transfer ] [ Designated as safety issue: No ]
    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)


Estimated Enrollment: 346
Study Start Date: February 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Cook Soft-Trans ET catheter (Cook Medical Inc., Bloomington, IN, USA)

  Eligibility

Ages Eligible for Study:   18 Years to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01805505

Contacts
Contact: Erik E Hauzman, MD, PhD +34 911 802 900 erik.hauzman@ivi.es

Locations
Spain
IVI Madrid Recruiting
Madrid, Spain, 28023
Sponsors and Collaborators
IVI Madrid
Investigators
Principal Investigator: Erik E Hauzman, MD, PhD IVI Madrid
Study Director: Juan A Garcia-Velasco, MD, PhD IVI Madrid
  More Information

No publications provided

Responsible Party: IVI Madrid
ClinicalTrials.gov Identifier: NCT01805505     History of Changes
Other Study ID Numbers: MAD-EH-01-2012-01
Study First Received: March 1, 2013
Last Updated: March 4, 2013
Health Authority: Spain: Ethics Committee

Keywords provided by IVI Madrid:
Female infertility
Oocyte donation
Embryo transfer
Transvaginal ultrasonography
Transabdominal ultrasonography

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on May 21, 2013