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TerminatedNCT01228474Updated Jul 1, 2015

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

An interventional study of Select the Number of embryos to transfer in Infertility, Oocyte Recipient and Single Embryo Transfer/Double Embryo Transfer, sponsored by Fundacion Dexeus. Terminated at 1 site in Spain. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2015-07-01.

Sponsored by Fundacion Dexeus · Not applicable, Interventional, and Treatment

Why this study was terminated
Due to the high number of multiples pregnancies in the double embryo transfer group, we have decided to stop the enrollment of patients at 07/31/2012
Phase
Not applicable
Study type
Interventional
Enrollment
65
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
Female
01

Study 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

02

Conditions studied

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

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03

In context

Infertility

2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.

This study's enrollment of 65 is below the median of 120 across 1,698 interventional studies indexed under Infertility.

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Lead sponsor

Fundacion Dexeus is the lead sponsor of 36 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
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

Exclusion Criteria:

  • medical indications to transfer only one embryo (Turner Syndrome, uterine surgical history, uterine myomas,...)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
65 participants (actual)

Study arms

  • Experimental
    SET

    Single embryo transfer

    Other: Select the Number of embryos to transfer

  • Active comparator
    DET

    Double embryo transfer

    Other: Select the Number of embryos to transfer

Interventions

  • OtherSelect the Number of embryos to transfer

    Select the Number of embryos to transfer

06

What researchers measure

Primary outcomes

  1. 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

  1. Cumulative live birth rate

  2. Multiple pregnancy rate

  3. Time needed to achieve the pregnancy

07

Study locations

1 site
  • Departamento de Obstetricia, Ginecología y Reproducción. Institut Universitari Dexeus
    Barcelona, 08028, Spain
08

References and documents

Publications

  • 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. PubMed 17908406 ↗
  • 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. PubMed 12923139 ↗

Related links

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 1, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01228474
Lead sponsor
Fundacion Dexeus
Responsible party
Ignacio Rodriguez (Bsc, Fundacion Dexeus) — Principal investigator
First posted
Oct 26, 2010
Start date
Oct 2010
Primary completion
Dec 2012
Completion
Dec 2012
Last update
Jul 1, 2015
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.

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