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

Sponsor
IVI Madrid (Other)
Overall Status
Terminated
CT.gov ID
NCT01805505
Collaborator
(none)
346
Enrollment
1
Location
2
Arms
58
Duration (Months)
6
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Transvaginal ultrasound-guided embryo transfer
  • Procedure: Transabdominal ultrasound-guided embryo transfer
 Early Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
346 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Comparison of Embryo Transfer in Egg Donation Recipients With Transvaginal and Transabdominal Ultrasound
Study Start Date :
Feb 1, 2012
Actual Primary Completion Date :
Dec 1, 2016
Actual Study Completion Date :
Dec 1, 2016

Arms and Interventions

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)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Pregnancy rate [At performing the pregnancy test 11 days post-embryo transfer]

      Proportion of patients with a positive pregnancy test

    Secondary Outcome Measures

    1. Clinical pregnancy rate [At first pregnancy ultrasound (3 weeks post-embryo transfer)]

      Proportion of patients with at least one gestational sac at first pregnancy ultrasound

    2. Ongoing pregnancy rate [At 10 weeks post-embryo transfer]

      Proportion of patients with at least one live intrauterine fetus at 10 weeks post-embryo transfer

    3. Menstruation-like pain [At embryo transfer]

      Measured on a three-level scale (none/mild/strong)

    4. Discomfort related to vesical distension [At embryo transfer]

      Measured on a three-level scale (none/mild/strong)

    5. Overall discomfort [At embryo transfer]

      Measured on a three-level scale (none/mild/strong)

    6. Difficulty using the assigned technique faced by operators [At embryo transfer]

      Measured on a three-level scale (easy/moderately difficult/very difficult)

    7. Catheterization time [At embryo transfer]

    8. Conversion to the opposite technique [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)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 49 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 IVI Madrid 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    IVI Madrid
    ClinicalTrials.gov Identifier:
    NCT01805505
    Other Study ID Numbers:
    • MAD-EH-01-2012-01
    First Posted:
    Mar 6, 2013
    Last Update Posted:
    Mar 7, 2017
    Last Verified:
    Mar 1, 2017
    Keywords provided by IVI Madrid
    Female infertility
    Oocyte donation
    Embryo transfer
    Transvaginal ultrasonography
    Transabdominal ultrasonography
    Additional relevant MeSH terms:
    Infertility

    Study Results

    No Results Posted as of Mar 7, 2017