Back to resultsSingle Embryo Transfer vs. Double Embryo Transfer in an Oocyte Donation Programme
Primary Purpose
Infertility, Oocyte Recipient, Single Embryo Transfer/Double Embryo Transfer
Status
Terminated
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Select the Number of embryos to transfer
Sponsored by
About this trial
This is an interventional treatment trial for Infertility
Eligibility 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,…)
Sites / Locations
- Departamento de Obstetricia, Ginecología y Reproducción. Institut Universitari Dexeus
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
SET
DET
Arm Description
Single embryo transfer
Double embryo transfer
Outcomes
Primary Outcome Measures
Cumulative pregnancy rate
Secondary Outcome Measures
Cumulative live birth rate
Multiple pregnancy rate
Time needed to achieve the pregnancy
Full Information
NCT ID
NCT01228474
First Posted
October 25, 2010
Last Updated
June 30, 2015
Sponsor
Institut Universitari Dexeus
1. Study Identification
Unique Protocol Identification Number
NCT01228474
Brief Title
Single Embryo Transfer vs. Double Embryo Transfer in an Oocyte Donation Programme
Official Title
A Prospective, Randomized, Controlled Trial Comparing SET vs DET in an Oocyte Donation Programme
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Terminated
Why Stopped
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
Study Start Date
October 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut Universitari Dexeus
4. Oversight
5. Study Description
Brief Summary
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility, Oocyte Recipient, Single Embryo Transfer/Double Embryo Transfer, Cumulative Pregnancy Rate, Multiple Pregnancy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SET
Arm Type
Experimental
Arm Description
Single embryo transfer
Arm Title
DET
Arm Type
Active Comparator
Arm Description
Double embryo transfer
Intervention Type
Other
Intervention Name(s)
Select the Number of embryos to transfer
Intervention Description
Select the Number of embryos to transfer
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Cumulative live birth rate
Title
Multiple pregnancy rate
Title
Time needed to achieve the pregnancy
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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,…)
Facility Information:
Facility Name
Departamento de Obstetricia, Ginecología y Reproducción. Institut Universitari Dexeus
City
Barcelona
ZIP/Postal Code
08028
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
17908406
Citation
Soderstrom-Anttila V, Vilska S. Five years of single embryo transfer with anonymous and non-anonymous oocyte donation. Reprod Biomed Online. 2007 Oct;15(4):428-33. doi: 10.1016/s1472-6483(10)60369-0.
Results Reference
background
PubMed Identifier
12923139
Citation
Soderstrom-Anttila V, Vilska S, Makinen S, Foudila T, Suikkari AM. Elective single embryo transfer yields good delivery rates in oocyte donation. Hum Reprod. 2003 Sep;18(9):1858-63. doi: 10.1093/humrep/deg384.
Results Reference
background
Links:
URL
http://www.dexeus.com
Description
Related Info
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Single Embryo Transfer vs. Double Embryo Transfer in an Oocyte Donation Programme
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