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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01805505
• Other study ID #: MAD-EH-01-2012-01
• Status: Terminated
• Phase: Early Phase 1
• First received: March 1, 2013
• Last updated: March 5, 2017
• Start date: February 2012
• Est. completion date: December 2016

Study information

• Verified date: March 2017
• Source: IVI Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 346
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 49 Years

Eligibility

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

Related Conditions & MeSH terms

• Infertility

Intervention

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
• 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

Locations

Country	Name	City	State
Spain	IVI Madrid	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
IVI Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy rate	Proportion of patients with a positive pregnancy test	At performing the pregnancy test 11 days post-embryo transfer
Secondary	Clinical pregnancy rate	Proportion of patients with at least one gestational sac at first pregnancy ultrasound	At first pregnancy ultrasound (3 weeks post-embryo transfer)
Secondary	Ongoing pregnancy rate	Proportion of patients with at least one live intrauterine fetus at 10 weeks post-embryo transfer	At 10 weeks post-embryo transfer
Secondary	Menstruation-like pain	Measured on a three-level scale (none/mild/strong)	At embryo transfer
Secondary	Discomfort related to vesical distension	Measured on a three-level scale (none/mild/strong)	At embryo transfer
Secondary	Overall discomfort	Measured on a three-level scale (none/mild/strong)	At embryo transfer
Secondary	Difficulty using the assigned technique faced by operators	Measured on a three-level scale (easy/moderately difficult/very difficult)	At embryo transfer
Secondary	Catheterization time		At embryo transfer
Secondary	Conversion to the opposite technique	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)	At embryo transfer