We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
  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
Intervention Model: Parallel Assignment
Masking: None (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 Ignacio Rodriguez, 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 ]

Secondary Outcome Measures:
  • Cumulative live birth rate
  • Multiple pregnancy rate
  • Time needed to achieve the pregnancy

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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes 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
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): 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:
Publications:
Responsible Party: Ignacio Rodriguez, Bsc, Institut Universitari Dexeus
ClinicalTrials.gov Identifier: NCT01228474     History of Changes
Other Study ID Numbers: DEX003
First Submitted: October 25, 2010
First Posted: October 26, 2010
Last Update Posted: July 1, 2015
Last Verified: June 2015

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