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

This study has been terminated.
(slow recruitment rate)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01805505
First Posted: March 6, 2013
Last Update Posted: March 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
IVI Madrid
  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 Phase
Infertility Procedure: Transvaginal ultrasound-guided embryo transfer Procedure: Transabdominal ultrasound-guided embryo transfer Early Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


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

  • 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

  • Menstruation-like pain [ Time Frame: At embryo transfer ]
    Measured on a three-level scale (none/mild/strong)

  • Discomfort related to vesical distension [ Time Frame: At embryo transfer ]
    Measured on a three-level scale (none/mild/strong)

  • Overall discomfort [ Time Frame: At embryo transfer ]
    Measured on a three-level scale (none/mild/strong)

  • Difficulty using the assigned technique faced by operators [ Time Frame: At embryo transfer ]
    Measured on a three-level scale (easy/moderately difficult/very difficult)

  • Catheterization time [ Time Frame: 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)


Enrollment: 346
Study Start Date: February 2012
Study Completion Date: December 2016
Primary Completion Date: December 2016 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 49 Years   (Adult)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01805505


Locations
Spain
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
  More Information

Responsible Party: IVI Madrid
ClinicalTrials.gov Identifier: NCT01805505     History of Changes
Other Study ID Numbers: MAD-EH-01-2012-01
First Submitted: March 1, 2013
First Posted: March 6, 2013
Last Update Posted: March 7, 2017
Last Verified: March 2017

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