Single Embryo Transfer Versus Double Embryo Transfer
Primary Purpose
Infertility
Status
Terminated
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Double Embryo Transfer (DET)
Single Embryo Transfer (SET)
Sponsored by
About this trial
This is an interventional prevention trial for Infertility focused on measuring Infertility, IVF, SET, DET, Blastocyst
Eligibility Criteria
Inclusion Criteria:G
- Good prognosis IVF patients
Exclusion Criteria:
- Bad prognosis IVF patients
Sites / Locations
- IVI-Sevilla
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
SET on day 3
DET on day 3
SET on day 5
DET on day 5
Arm Description
Single embryo transfer on day 3 of embryo development
Double embryo transfer on day 3 of embryo development
Single embryo transfer on day 5 of embryo development
Double embryo transfer on day 5 of embryo development
Outcomes
Primary Outcome Measures
Live-birth delivery rate
Secondary Outcome Measures
Multiple live-birth rate
Acceptance of assigned randomised group
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00814398
Brief Title
Single Embryo Transfer Versus Double Embryo Transfer
Official Title
Single Embryo Transfer Versus Double Embryo Transfer in Day 3 or Blastocyst Stage
Study Type
Interventional
2. Study Status
Record Verification Date
March 2011
Overall Recruitment Status
Terminated
Why Stopped
Change in cryopreservation protocol
Study Start Date
December 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IVI Sevilla
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this project is to study the best number (1 or 2)and day (3 vs 5)of embryo transfer in good prognosis patient.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Infertility, IVF, SET, DET, Blastocyst
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
199 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SET on day 3
Arm Type
Experimental
Arm Description
Single embryo transfer on day 3 of embryo development
Arm Title
DET on day 3
Arm Type
Experimental
Arm Description
Double embryo transfer on day 3 of embryo development
Arm Title
SET on day 5
Arm Type
Experimental
Arm Description
Single embryo transfer on day 5 of embryo development
Arm Title
DET on day 5
Arm Type
Experimental
Arm Description
Double embryo transfer on day 5 of embryo development
Intervention Type
Procedure
Intervention Name(s)
Double Embryo Transfer (DET)
Intervention Description
Two embryos are transferred during an IVF treatment
Intervention Type
Procedure
Intervention Name(s)
Single Embryo Transfer (SET)
Intervention Description
A single embryo is transferred during an IVF treatment
Primary Outcome Measure Information:
Title
Live-birth delivery rate
Time Frame
End of pregnancy (nine months after last transfer)
Secondary Outcome Measure Information:
Title
Multiple live-birth rate
Time Frame
End of pregnancy (nine months after last transfer)
Title
Acceptance of assigned randomised group
Time Frame
Day of randomisation
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
37 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:G
Good prognosis IVF patients
Exclusion Criteria:
Bad prognosis IVF patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manuel Fernandez, MD
Organizational Affiliation
IVI Sevilla
Official's Role
Principal Investigator
Facility Information:
Facility Name
IVI-Sevilla
City
Seville
ZIP/Postal Code
41011
Country
Spain
12. IPD Sharing Statement
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Single Embryo Transfer Versus Double Embryo Transfer
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