Single Embryo Transfer vs. Double Embryo Transfer in an Oocyte Donation Programme

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01228474
• Other study ID #: DEX003
• Status: Terminated
• Phase: N/A
• First received: October 25, 2010
• Last updated: June 30, 2015
• Start date: October 2010
• Est. completion date: December 2012

Study information

• Verified date: June 2015
• Source: Institut Universitari Dexeus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 65
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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,…)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cumulative Pregnancy Rate
• Infertility
• Multiple Pregnancy
• Oocyte Recipient
• Single Embryo Transfer/Double Embryo Transfer

Intervention

Other:
• Select the Number of embryos to transfer
Select the Number of embryos to transfer

Locations

Country	Name	City	State
Spain	Departamento de Obstetricia, Ginecología y Reproducción. Institut Universitari Dexeus	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Institut Universitari Dexeus

Country where clinical trial is conducted

Spain, 

References & Publications (2)

Söderström-Anttila V, Vilska S, Mäkinen S, Foudila T, Suikkari AM. Elective single embryo transfer yields good delivery rates in oocyte donation. Hum Reprod. 2003 Sep;18(9):1858-63. — View Citation

Söderström-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Cumulative live birth rate			No
Secondary	Multiple pregnancy rate			No
Secondary	Time needed to achieve the pregnancy			No

External Links

•   Link