Efficacy of Embryo Transfer Procedure Guided by Transvaginal Ultrasound Versus Abdominal Ultrasound in Oocytes Recipients
Primary Purpose
Infertility
Status
Completed
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
ultrasound-guided embryo transfer
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring Female infertility with indication of oocyte reception
Eligibility Criteria
Inclusion Criteria:
- Oocyte recipients.
- Uterus without previously detected anomalies.
- Patients able to understand the study requirements who want to participate during all its duration and that have signed the informed consent.
Exclusion Criteria:
- Turner syndrome, Black race (significantly lower implantational rates)
Sites / Locations
- Clinica EUGIN
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
abdominal ultrasound
transvaginal ultrasound
Arm Description
traditional technique
new technique
Outcomes
Primary Outcome Measures
Clinical pregnancy rate
Evidence of gestational sac by transvaginal ultrasound
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01137461
Brief Title
Efficacy of Embryo Transfer Procedure Guided by Transvaginal Ultrasound Versus Abdominal Ultrasound in Oocytes Recipients
Official Title
Evaluation of Efficacy of Embryo Transfer Procedure Guided by Transvaginal Ultrasound Versus Abdominal Ultrasound in Recipients of Oocytes. A Single-centre, Randomized Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Fundació Privada Eugin
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The objective of this study is to evaluate the efficacy of embryo transfer procedure guided by transvaginal ultrasound versus abdominal ultrasound in recipients of oocytes as well as the advantages and disadvantages of the new technique.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Female infertility with indication of oocyte reception
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
330 (Actual)
8. Arms, Groups, and Interventions
Arm Title
abdominal ultrasound
Arm Type
Other
Arm Description
traditional technique
Arm Title
transvaginal ultrasound
Arm Type
Other
Arm Description
new technique
Intervention Type
Procedure
Intervention Name(s)
ultrasound-guided embryo transfer
Intervention Description
Embryo transfer in oocyte recipients
Primary Outcome Measure Information:
Title
Clinical pregnancy rate
Description
Evidence of gestational sac by transvaginal ultrasound
Time Frame
40 days after embryo transfer
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Oocyte recipients.
Uterus without previously detected anomalies.
Patients able to understand the study requirements who want to participate during all its duration and that have signed the informed consent.
Exclusion Criteria:
Turner syndrome, Black race (significantly lower implantational rates)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Bodri
Organizational Affiliation
Clinica EUGIN
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinica EUGIN
City
Barcelona
ZIP/Postal Code
08029
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
21459374
Citation
Bodri D, Colodron M, Garcia D, Obradors A, Vernaeve V, Coll O. Transvaginal versus transabdominal ultrasound guidance for embryo transfer in donor oocyte recipients: a randomized clinical trial. Fertil Steril. 2011 Jun;95(7):2263-8, 2268.e1. doi: 10.1016/j.fertnstert.2011.03.028. Epub 2011 Apr 2.
Results Reference
result
Links:
URL
http://www.eugin.es/
Description
Clínica EUGIN
Learn more about this trial
Efficacy of Embryo Transfer Procedure Guided by Transvaginal Ultrasound Versus Abdominal Ultrasound in Oocytes Recipients
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