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

NCT ID: NCT01805505

Last Updated: 2017-03-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 346 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-02-29
• Study Completion Date: 2016-12-31

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.

Conditions

Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Transvaginal ultrasound-guided embryo transfer

Transvaginal ultrasound-guided transfer of two day-3 embryos

Group Type: EXPERIMENTAL

Transvaginal ultrasound-guided embryo transfer

Intervention Type: PROCEDURE

Embryo transfer of two day-3 embryos performed with the Kitazato Long ET catheter (Kitazato Medical Co. Ltd., Tokyo, Japan), guided by transvaginal ultrasound

Transabdominal ultrasound-guided embryo transfer

Transabdominal ultrasound-guided transfer of two day-3 embryos

Group Type: ACTIVE_COMPARATOR

Transabdominal ultrasound-guided embryo transfer

Intervention Type: PROCEDURE

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

Interventions

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

Intervention Type: 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

Intervention Type: PROCEDURE

Other Intervention Names

Kitazato Long ET catheter (Kitazato Medical Co. Ltd., Tokyo, Japan); Cook Soft-Trans ET catheter (Cook Medical Inc., Bloomington, IN, USA)

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 49 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

IVI Madrid

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erik E Hauzman, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

IVI Madrid

Juan A Garcia-Velasco, MD, PhD

Role: STUDY_DIRECTOR

IVI Madrid

Locations

IVI Madrid

Madrid, , Spain

Countries

Spain

Other Identifiers

MAD-EH-01-2012-01

Identifier Type: -

Identifier Source: org_study_id