Back to resultsEmbryo Transfer: Direct Versus Afterloading Trial
Primary Purpose
Infertility
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Afterloading embryo transfer procedure
Direct embryo transfer procedure
Sponsored by
About this trial
This is an interventional treatment trial for Infertility focused on measuring Embryo transfer, IVF, Ultrasound embryo transfer
Eligibility Criteria
Inclusion Criteria:
- Patients in IVF/CICSI program
- Transfer day:2 or 3 after ovum pick-up
Exclusion Criteria:
- None
Sites / Locations
- Departamento de Obstetricia Ginecologia y Reproducción. Institut Universitari Dexeus
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
1
2
Arm Description
Afterloading embryo transfer procedure
Direct embryo transfer procedure
Outcomes
Primary Outcome Measures
Clinical pregnancy
Secondary Outcome Measures
Difficulty of embryo transfer
Duration of embryo transfer
Full Information
NCT ID
NCT00824629
First Posted
January 16, 2009
Last Updated
October 25, 2010
Sponsor
Institut Universitari Dexeus
1. Study Identification
Unique Protocol Identification Number
NCT00824629
Brief Title
Embryo Transfer: Direct Versus Afterloading Trial
Official Title
Direct Transfer vs Previous Cervical Canalization Transfer ("Afterloading"): Randomized Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Institut Universitari Dexeus
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to evaluate two types of embryo transfer procedure.
The investigators will compare direct embryo transfer against afterloading embryo transfer.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility
Keywords
Embryo transfer, IVF, Ultrasound embryo transfer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
Afterloading embryo transfer procedure
Arm Title
2
Arm Type
Active Comparator
Arm Description
Direct embryo transfer procedure
Intervention Type
Procedure
Intervention Name(s)
Afterloading embryo transfer procedure
Intervention Description
Afterloading embryo transfer procedure
Intervention Type
Procedure
Intervention Name(s)
Direct embryo transfer procedure
Intervention Description
Direct embryo transfer procedure
Primary Outcome Measure Information:
Title
Clinical pregnancy
Time Frame
8 weeks after embryo transfer
Secondary Outcome Measure Information:
Title
Difficulty of embryo transfer
Time Frame
During embryo transfer procedure
Title
Duration of embryo transfer
Time Frame
During embryo transfer procedure
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
42 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients in IVF/CICSI program
Transfer day:2 or 3 after ovum pick-up
Exclusion Criteria:
None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Buenaventura Coroleu, PhD., MD.
Organizational Affiliation
Departamento de Obstetricia, Ginecologia y Reproduccion , Institut Universitari Dexeus
Official's Role
Study Director
Facility Information:
Facility Name
Departamento de Obstetricia Ginecologia y Reproducción. Institut Universitari Dexeus
City
Barcelona
ZIP/Postal Code
08037
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
10686207
Citation
Coroleu B, Carreras O, Veiga A, Martell A, Martinez F, Belil I, Hereter L, Barri PN. Embryo transfer under ultrasound guidance improves pregnancy rates after in-vitro fertilization. Hum Reprod. 2000 Mar;15(3):616-20. doi: 10.1093/humrep/15.3.616.
Results Reference
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PubMed Identifier
11821275
Citation
Coroleu B, Barri PN, Carreras O, Martinez F, Parriego M, Hereter L, Parera N, Veiga A, Balasch J. The influence of the depth of embryo replacement into the uterine cavity on implantation rates after IVF: a controlled, ultrasound-guided study. Hum Reprod. 2002 Feb;17(2):341-6. doi: 10.1093/humrep/17.2.341.
Results Reference
background
PubMed Identifier
12407044
Citation
Coroleu B, Barri PN, Carreras O, Martinez F, Veiga A, Balasch J. The usefulness of ultrasound guidance in frozen-thawed embryo transfer: a prospective randomized clinical trial. Hum Reprod. 2002 Nov;17(11):2885-90. doi: 10.1093/humrep/17.11.2885.
Results Reference
background
PubMed Identifier
16556674
Citation
Coroleu B, Barri PN, Carreras O, Belil I, Buxaderas R, Veiga A, Balasch J. Effect of using an echogenic catheter for ultrasound-guided embryo transfer in an IVF programme: a prospective, randomized, controlled study. Hum Reprod. 2006 Jul;21(7):1809-15. doi: 10.1093/humrep/del045. Epub 2006 Mar 23.
Results Reference
background
PubMed Identifier
15192071
Citation
Matorras R, Mendoza R, Exposito A, Rodriguez-Escudero FJ. Influence of the time interval between embryo catheter loading and discharging on the success of IVF. Hum Reprod. 2004 Sep;19(9):2027-30. doi: 10.1093/humrep/deh366. Epub 2004 Jun 10.
Results Reference
background
PubMed Identifier
15749502
Citation
Neithardt AB, Segars JH, Hennessy S, James AN, McKeeby JL. Embryo afterloading: a refinement in embryo transfer technique that may increase clinical pregnancy. Fertil Steril. 2005 Mar;83(3):710-4. doi: 10.1016/j.fertnstert.2004.08.022.
Results Reference
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Links:
URL
http://www.dexeus.com
Description
Related Info
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Embryo Transfer: Direct Versus Afterloading Trial
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