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Single Embryo Transfer vs. Double Embryo Transfer in an Oocyte Donation Programme

This study has been terminated.
(Due to the high number of multiples pregnancies in the double embryo transfer group, we have decided to stop the enrollment of patients at 07/31/2012)
Sponsor:
Information provided by:
Institut Universitari Dexeus
ClinicalTrials.gov Identifier:
NCT01228474
First received: October 25, 2010
Last updated: October 2, 2012
Last verified: October 2010
History of Changes
  Purpose

Experimental study to assess the efficacy of single embryo transfer (SET) with respect to double embryo transfer (DET) in an oocyte donation programme, 160 recipients will be randomized in two groups


Condition Intervention
Infertility
Oocyte Recipient
Single Embryo Transfer/Double Embryo Transfer
Cumulative Pregnancy Rate
Multiple Pregnancy
 Other: Select the Number of embryos to transfer

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective, Randomized, Controlled Trial Comparing SET vs DET in an Oocyte Donation Programme

Resource links provided by NLM:

MedlinePlus related topics: Infertility
U.S. FDA Resources

Further study details as provided by Institut Universitari Dexeus:

Primary Outcome Measures:
  • Cumulative pregnancy rate [ Time Frame: at 12 months of fresh embryo transfer (time considered enough in order to do a minimum of one frozen-thawed cycle if pregnancy is not achieved with the fresh cycle ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cumulative live birth rate [ Designated as safety issue: No ]
  • Multiple pregnancy rate [ Designated as safety issue: No ]
  • Time needed to achieve the pregnancy [ Designated as safety issue: No ]

Enrollment: 65
Study Start Date: October 2010
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SET
Single embryo transfer
 Other: Select the Number of embryos to transfer
Select the Number of embryos to transfer
Active Comparator: DET
Double embryo transfer
 Other: Select the Number of embryos to transfer
Select the Number of embryos to transfer

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients under their first or second cycle of a synchronous donation
  • to have a minimum of 5 available embryos to transfer
  • patients who accept transfers of frozen-thawed embryos

Exclusion Criteria:

  • medical indications to transfer only one embryo (Turner Syndrome, uterine surgical history, uterine myomas,…)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01228474

Locations
Spain
Departamento de Obstetricia, Ginecología y Reproducción. Institut Universitari Dexeus
Barcelona, Spain, 08028
Sponsors and Collaborators
Institut Universitari Dexeus
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Elisabet Clua Obradó, Departamento de Obstetricia, Ginecología y Reproducción Institut Universitari Dexeus
ClinicalTrials.gov Identifier: NCT01228474     History of Changes
Other Study ID Numbers: DEX003
Study First Received: October 25, 2010
Last Updated: October 2, 2012
Health Authority: Spain: Comité Ético de Investigación Clínica

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

ClinicalTrials.gov processed this record on May 19, 2013