Study Stopped
Due to the clinically and statistically significant inferior results for the D3 group following evaluation by the institutional review board.
Transfer Strategy in an Oocyte Donation Programme
Pilot Study of the Best Transfer Strategy in an Oocyte Donation Programme: an Intention to Treat Randomized Controlled Trial
1 other identifier
interventional
134
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 18, 2017
CompletedFirst Posted
Study publicly available on registry
March 23, 2017
CompletedStudy Start
First participant enrolled
April 5, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
August 31, 2019
CompletedJune 29, 2021
June 1, 2021
2.4 years
March 18, 2017
June 28, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Cumulative live birth rate
Total number of births considering fresh and frozen thawed embryos transferred
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 Outcomes (1)
Cumulative pregnancy rate
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
Study Arms (2)
Blastocyst-stage embryo transfer strategy
EXPERIMENTALCleavage-stage embryo transfer strategy
ACTIVE COMPARATORInterventions
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.
Inta-uterine transferring of cleavage embryo transfer (day 3 of develpment) in oocyte recipients
Eligibility Criteria
You may qualify if:
- Patients under their first or second cycle of a synchronous (fresh) oocyte donation cycle.
You may not qualify if:
- Preimplantation genetic screening or diagnosis cycles.
- Patients with strict blastocyst-stage embryo transfer indication by the couple's treating physician.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fundacion Dexeuslead
Study Sites (1)
Department Obstetric, Gynecologic and Reproductive Medicine
Barcelona, Barcelons, 08028, Spain
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Gamete and Embryo Donation
Study Record Dates
First Submitted
March 18, 2017
First Posted
March 23, 2017
Study Start
April 5, 2017
Primary Completion
August 31, 2019
Study Completion
August 31, 2019
Last Updated
June 29, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will not share