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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:
ClinicalTrials.gov Identifier:
NCT01228474
First Posted: October 26, 2010
Last Update Posted: July 1, 2015
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 (Responsible Party):
Ignacio Rodriguez, Institut Universitari Dexeus
October 25, 2010
October 26, 2010
July 1, 2015
October 2010
December 2012   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01228474 on ClinicalTrials.gov Archive Site
  • Cumulative live birth rate
  • Multiple pregnancy rate
  • Time needed to achieve the pregnancy
Same as current
Not Provided
Not Provided
 
Single Embryo Transfer vs. Double Embryo Transfer in an Oocyte Donation Programme
A Prospective, Randomized, Controlled Trial Comparing SET vs DET in an Oocyte Donation Programme
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
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Infertility
  • Oocyte Recipient
  • Single Embryo Transfer/Double Embryo Transfer
  • Cumulative Pregnancy Rate
  • Multiple Pregnancy
Other: Select the Number of embryos to transfer
Select the Number of embryos to transfer
  • Experimental: SET
    Single embryo transfer
    Intervention: Other: Select the Number of embryos to transfer
  • Active Comparator: DET
    Double embryo transfer
    Intervention: Other: Select the Number of embryos to transfer

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
65
December 2012
December 2012   (Final data collection date for primary outcome measure)

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,…)
Sexes Eligible for Study: Female
18 Years to 50 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
 
NCT01228474
DEX003
Not Provided
Not Provided
Not Provided
Ignacio Rodriguez, Institut Universitari Dexeus
Institut Universitari Dexeus
Not Provided
Not Provided
Institut Universitari Dexeus
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP