Transfer Strategy in an Oocyte Donation Programme
Primary Purpose
Oocyte Donation, Infertility, Female, Embryo Transfer
Status
Terminated
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Blastocyst-stage embryo transfer strategy
Cleavage-stage embryo transfer strategy
Sponsored by
About this trial
This is an interventional other trial for Oocyte Donation
Eligibility Criteria
Inclusion Criteria:
- Patients under their first or second cycle of a synchronous (fresh) oocyte donation cycle.
Exclusion Criteria:
- Preimplantation genetic screening or diagnosis cycles.
- Patients with strict blastocyst-stage embryo transfer indication by the couple's treating physician.
Sites / Locations
- Department Obstetric, Gynecologic and Reproductive Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Blastocyst-stage embryo transfer strategy
Cleavage-stage embryo transfer strategy
Arm Description
Outcomes
Primary Outcome Measures
Cumulative live birth rate
Total number of births considering fresh and frozen thawed embryos transferred
Secondary Outcome Measures
Cumulative pregnancy rate
Total number of pregnancies confirmed by ultrasound 6 weeks after embryo transfer including fresh and thawed embryos.
Full Information
NCT ID
NCT03088735
First Posted
March 18, 2017
Last Updated
June 28, 2021
Sponsor
Institut Universitari Dexeus
1. Study Identification
Unique Protocol Identification Number
NCT03088735
Brief Title
Transfer Strategy in an Oocyte Donation Programme
Official Title
Pilot Study of the Best Transfer Strategy in an Oocyte Donation Programme: an Intention to Treat Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Terminated
Why Stopped
Due to the clinically and statistically significant inferior results for the D3 group following evaluation by the institutional review board.
Study Start Date
April 5, 2017 (Actual)
Primary Completion Date
August 31, 2019 (Actual)
Study Completion Date
August 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institut Universitari Dexeus
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
It has been previously shown that although the activation of the embryonic genome can begin as early as two days of initiation of the embryonic development (D2), it is expressed on day 3 (D3). Without this activation, the embryo can not continue its development. Therefore, it has been suggested that extended culture to blastocyst stage could be an option to identify and better select embryos that have been able to carry out this activation. The purpose of this study is to compare cumulative pregnancy and live birth rates following transfer of cleavage embryos or blastocysts.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oocyte Donation, Infertility, Female, Embryo Transfer
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
134 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Blastocyst-stage embryo transfer strategy
Arm Type
Experimental
Arm Title
Cleavage-stage embryo transfer strategy
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Blastocyst-stage embryo transfer strategy
Intervention Description
Intra-uterine transfer of blastocist if in cleavage embryo stage the oocyte recipient has a mínimum of 3 availables embryos with at least one of good quality to transfer and also the inta-uterine transfer of cleavage embryo (day 3) when the recipient doesn't have the previous criteria.
Intervention Type
Procedure
Intervention Name(s)
Cleavage-stage embryo transfer strategy
Intervention Description
Inta-uterine transferring of cleavage embryo transfer (day 3 of develpment) in oocyte recipients
Primary Outcome Measure Information:
Title
Cumulative live birth rate
Description
Total number of births considering fresh and frozen thawed embryos transferred
Time Frame
at 12 months after a 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 pregnancy rate
Description
Total number of pregnancies confirmed by ultrasound 6 weeks after embryo transfer including fresh and thawed embryos.
Time Frame
at 12 months after a 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
10. Eligibility
Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients under their first or second cycle of a synchronous (fresh) oocyte donation cycle.
Exclusion Criteria:
Preimplantation genetic screening or diagnosis cycles.
Patients with strict blastocyst-stage embryo transfer indication by the couple's treating physician.
Facility Information:
Facility Name
Department Obstetric, Gynecologic and Reproductive Medicine
City
Barcelona
State/Province
Barcelons
ZIP/Postal Code
08028
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.dexeus.com
Description
Related Info
Learn more about this trial
Transfer Strategy in an Oocyte Donation Programme
We'll reach out to this number within 24 hrs