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Embryo Transfer: Direct Versus Afterloading Trial

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00824629
First Posted: January 19, 2009
Last Update Posted: October 26, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Institut Universitari Dexeus
  Purpose

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.


Condition Intervention
Infertility Procedure: Afterloading embryo transfer procedure Procedure: Direct embryo transfer procedure

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Direct Transfer vs Previous Cervical Canalization Transfer ("Afterloading"): Randomized Clinical Trial.

Further study details as provided by Institut Universitari Dexeus:

Primary Outcome Measures:
  • Clinical pregnancy [ Time Frame: 8 weeks after embryo transfer ]

Secondary Outcome Measures:
  • Difficulty of embryo transfer [ Time Frame: During embryo transfer procedure ]
  • Duration of embryo transfer [ Time Frame: During embryo transfer procedure ]

Estimated Enrollment: 400
Study Start Date: October 2008
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 42 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00824629


Locations
Spain
Departamento de Obstetricia Ginecologia y Reproducción. Institut Universitari Dexeus
Barcelona, Spain, 08037
Sponsors and Collaborators
Institut Universitari Dexeus
Investigators
Study Director: Buenaventura Coroleu, PhD., MD. Departamento de Obstetricia, Ginecologia y Reproduccion , Institut Universitari Dexeus
  More Information

Additional Information:
Publications:
Responsible Party: Buenaventura Coroleu, Departamento de Obstetricia, Ginecologia y Reproducción
ClinicalTrials.gov Identifier: NCT00824629     History of Changes
Other Study ID Numbers: DEX001
First Submitted: January 16, 2009
First Posted: January 19, 2009
Last Update Posted: October 26, 2010
Last Verified: August 2009

Keywords provided by Institut Universitari Dexeus:
Embryo transfer
IVF
Ultrasound embryo transfer

Additional relevant MeSH terms:
Infertility
Genital Diseases, Male
Genital Diseases, Female