NCT01228474

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Study Start

First participant enrolled

October 1, 2010

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

October 25, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 26, 2010

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

July 1, 2015

Status Verified

June 1, 2015

Enrollment Period

2.2 years

First QC Date

October 25, 2010

Last Update Submit

June 30, 2015

Conditions

InfertilityOocyte RecipientSingle Embryo Transfer/Double Embryo TransferCumulative Pregnancy RateMultiple Pregnancy

Outcome Measures

Primary Outcomes (1)

  • Cumulative pregnancy rate

    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 (3)

  • Cumulative live birth rate

  • Multiple pregnancy rate

  • Time needed to achieve the pregnancy

Study Arms (2)

SET

EXPERIMENTAL

Single embryo transfer

Other: Select the Number of embryos to transfer

DET

ACTIVE COMPARATOR

Double embryo transfer

Other: Select the Number of embryos to transfer

Interventions

Select the Number of embryos to transferOTHER

Select the Number of embryos to transfer

DETSET

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departamento de Obstetricia, Ginecología y Reproducción. Institut Universitari Dexeus

Barcelona, Barcelona, 08028, Spain

Location

Related Publications (2)

  • Soderstrom-Anttila V, Vilska S. Five years of single embryo transfer with anonymous and non-anonymous oocyte donation. Reprod Biomed Online. 2007 Oct;15(4):428-33. doi: 10.1016/s1472-6483(10)60369-0.

    PMID: 17908406BACKGROUND

  • Soderstrom-Anttila V, Vilska S, Makinen S, Foudila T, Suikkari AM. Elective single embryo transfer yields good delivery rates in oocyte donation. Hum Reprod. 2003 Sep;18(9):1858-63. doi: 10.1093/humrep/deg384.

    PMID: 12923139BACKGROUND

Related Links

MeSH Terms

Conditions

Infertility

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Bsc

Study Record Dates

First Submitted

October 25, 2010

First Posted

October 26, 2010

Study Start

October 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

July 1, 2015

Record last verified: 2015-06

Locations

ES(1)