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

Early Phase 1

Terminated

• Conditions: Infertility
• Interventions: Procedure: Transvaginal ultrasound-guided embryo transfer; Procedure: Transabdominal ultrasound-guided embryo transfer

• Registration Number: NCT01805505
• Lead Sponsor: IVI Madrid

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2013-03-01
• Study First Submitted QC: 2013-03-04
• Study First Posted: 2013-03-06
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-05
• Last Update Posted: 2017-03-07

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 346

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transvaginal ultrasound-guided embryo transfer	Transvaginal ultrasound-guided embryo transfer	Transvaginal ultrasound-guided transfer of two day-3 embryos
Transabdominal ultrasound-guided embryo transfer	Transabdominal ultrasound-guided embryo transfer	Transabdominal ultrasound-guided transfer of two day-3 embryos

Primary Outcome Measures

Name	Time	Method
Pregnancy rate	At performing the pregnancy test 11 days post-embryo transfer	Proportion of patients with a positive pregnancy test

Secondary Outcome Measures

Name	Time	Method
Menstruation-like pain	At embryo transfer	Measured on a three-level scale (none/mild/strong)
Discomfort related to vesical distension	At embryo transfer	Measured on a three-level scale (none/mild/strong)
Difficulty using the assigned technique faced by operators	At embryo transfer	Measured on a three-level scale (easy/moderately difficult/very difficult)
Catheterization time	At embryo transfer
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)
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
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
Overall discomfort	At embryo transfer	Measured on a three-level scale (none/mild/strong)

Trial Locations

Locations (1)

IVI Madrid; 🇪🇸 Madrid, Spain