Embryo Transfer: Direct Versus Afterloading Trial

October 25, 2010 updated by: Institut Universitari Dexeus

Direct Transfer vs Previous Cervical Canalization Transfer ("Afterloading"): Randomized Clinical Trial.

The purpose of this study is to evaluate two types of embryo transfer procedure.

The investigators will compare direct embryo transfer against afterloading embryo transfer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

400

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08037
        • Departamento de Obstetricia Ginecologia y Reproducción. Institut Universitari Dexeus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 42 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients in IVF/CICSI program
  • Transfer day:2 or 3 after ovum pick-up

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Afterloading embryo transfer procedure
Procedure: Afterloading embryo transfer procedure
Afterloading embryo transfer procedure
Active Comparator: 2
Direct embryo transfer procedure
Procedure: Direct embryo transfer procedure
Direct embryo transfer procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Clinical pregnancy
Time Frame: 8 weeks after embryo transfer
8 weeks after embryo transfer

Secondary Outcome Measures

Outcome Measure
Time Frame
Difficulty of embryo transfer
Time Frame: During embryo transfer procedure
During embryo transfer procedure
Duration of embryo transfer
Time Frame: During embryo transfer procedure
During embryo transfer procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Universitari Dexeus

Investigators

  • Study Director: Buenaventura Coroleu, PhD., MD., Departamento de Obstetricia, Ginecologia y Reproduccion , Institut Universitari Dexeus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

January 16, 2009

First Submitted That Met QC Criteria

January 16, 2009

First Posted (Estimate)

January 19, 2009

Study Record Updates

Last Update Posted (Estimate)

October 26, 2010

Last Update Submitted That Met QC Criteria

October 25, 2010

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DEX001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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