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)
Information provided by (Responsible Party):
Ignacio Rodriguez, Institut Universitari Dexeus Identifier:
First received: October 25, 2010
Last updated: June 30, 2015
Last verified: June 2015
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
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

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
Study Completion Date: December 2012
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


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

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,…)
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Please refer to this study by its identifier: NCT01228474

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

Additional Information:
Responsible Party: Ignacio Rodriguez, Bsc, Institut Universitari Dexeus Identifier: NCT01228474     History of Changes
Other Study ID Numbers: DEX003 
Study First Received: October 25, 2010
Last Updated: June 30, 2015
Health Authority: Spain: Comité Ético de Investigación Clínica processed this record on May 24, 2016