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Clinical Trials/NCT01228474
NCT01228474TerminatedNot Applicable

A Prospective, Randomized, Controlled Trial Comparing SET vs DET in an Oocyte Donation Programme

Institut Universitari Dexeus2 sites in 1 country65 target enrollmentStarted: October 1, 2010Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Sponsor
Enrollment
65
Locations
2
Primary Endpoint
Cumulative pregnancy rate
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

Experimental study to assess the efficacy of single embryo transfer (SET) with respect to double embryo transfer (DET) in an oocyte donation programme, 160 recipients will be randomized in two groups

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •patients under their first or second cycle of a synchronous donation
  • •to have a minimum of 5 available embryos to transfer
  • •patients who accept transfers of frozen-thawed embryos

Exclusion Criteria

  • •medical indications to transfer only one embryo (Turner Syndrome, uterine surgical history, uterine myomas,...)

Outcomes

Primary Outcomes

Cumulative pregnancy rate

Time Frame: at 12 months of fresh 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

  • Cumulative live birth rate
  • Time needed to achieve the pregnancy
  • Multiple pregnancy rate

Investigators

Sponsor
Institut Universitari Dexeus
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ignacio Rodriguez

Bsc

Institut Universitari Dexeus

Study Sites (2)

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