NCT01805505

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
346

participants targeted

Target at P75+ for early_phase_1

Timeline
Completed

Started Feb 2012

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 1, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 6, 2013

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

March 7, 2017

Status Verified

March 1, 2017

Enrollment Period

4.8 years

First QC Date

March 1, 2013

Last Update Submit

March 5, 2017

Conditions

Infertility

Keywords

Female infertilityOocyte donationEmbryo transferTransvaginal ultrasonographyTransabdominal ultrasonography

Outcome Measures

Primary Outcomes (1)

  • Pregnancy rate

    Proportion of patients with a positive pregnancy test

    At performing the pregnancy test 11 days post-embryo transfer

Secondary Outcomes (8)

  • Clinical pregnancy rate

    At first pregnancy ultrasound (3 weeks post-embryo transfer)

  • Ongoing pregnancy rate

    At 10 weeks post-embryo transfer

  • Menstruation-like pain

    At embryo transfer

  • Discomfort related to vesical distension

    At embryo transfer

  • Overall discomfort

    At embryo transfer

  • +3 more secondary outcomes

Study Arms (2)

Transvaginal ultrasound-guided embryo transfer

EXPERIMENTAL

Transvaginal ultrasound-guided transfer of two day-3 embryos

Procedure: Transvaginal ultrasound-guided embryo transfer

Transabdominal ultrasound-guided embryo transfer

ACTIVE COMPARATOR

Transabdominal ultrasound-guided transfer of two day-3 embryos

Procedure: Transabdominal ultrasound-guided embryo transfer

Interventions

Transvaginal ultrasound-guided embryo transferPROCEDURE

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

Also known as: Kitazato Long ET catheter (Kitazato Medical Co. Ltd., Tokyo, Japan)
Transvaginal ultrasound-guided embryo transfer
Transabdominal ultrasound-guided embryo transferPROCEDURE

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

Also known as: Cook Soft-Trans ET catheter (Cook Medical Inc., Bloomington, IN, USA)
Transabdominal ultrasound-guided embryo transfer

Eligibility Criteria

Age18 Years - 49 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients undergoing oocyte donation treatment with transfer of 2 embryos on day 3

You may not qualify if:

  • Submucous or \>3 cm intramural fibroids
  • Turner syndrome
  • Black recipients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IVI Madrid

Madrid, 28023, Spain

Location

MeSH Terms

Conditions

InfertilityInfertility, Female

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy Complications

Study Officials

  • Erik E Hauzman, MD, PhD

    IVI Madrid

    PRINCIPAL INVESTIGATOR

  • Juan A Garcia-Velasco, MD, PhD

    IVI Madrid

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 1, 2013

First Posted

March 6, 2013

Study Start

February 1, 2012

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

March 7, 2017

Record last verified: 2017-03

Locations

ES(1)