InfertilityNCT01228474
Single Embryo Transfer vs. Double Embryo Transfer in an Oocyte Donation Programme
A study testing Select the Number of embryos to transfer in people with Infertility and Oocyte Recipient, run by Fundacion Dexeus at 1 site in Spain.
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 Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Infertility, Oocyte Recipient, Single Embryo Transfer/Double Embryo Transfer
- What is being tested?
- Select the Number of embryos to transfer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteSpain
- Study dates
- Oct 2010to Dec 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- medical indications to transfer only one embryo (Turner Syndrome, uterine surgical history, uterine myomas,…)
Trial locations and contacts
1 site in 1 country.
Spain1 site
Departamento de Obstetricia, Ginecología y Reproducción. Institut Universitari Dexeus
Barcelona, Barcelona, 08028
About this study
Official title: A Prospective, Randomized, Controlled Trial Comparing SET vs DET in an Oocyte Donation Programme
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
- Conditions
- Infertility, Oocyte Recipient, Single Embryo Transfer/Double Embryo Transfer, Cumulative Pregnancy Rate, Multiple Pregnancy
- Being tested
- Select the Number of embryos to transfer
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Select the Number of embryos to transferOther
Select the Number of embryos to transfer
| Study group | Role | What they receive |
|---|---|---|
| SET | Experimental | Single embryo transfer Receives: Other: Select the Number of embryos to transfer |
| DET | Active comparator | Double embryo transfer Receives: Other: Select the Number of embryos to transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative pregnancy rate
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionDec 2012
- Study completionDec 2012
Why it stopped: 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
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for InfertilityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion Dexeus
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ignacio Rodriguez, Fundacion Dexeus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01228474
- Sponsor's protocol ID
- DEX003
- Status last verified
- Jun 2015
- First submitted
- 25 Oct 2010
- Last updated
- 1 Jul 2015
- Results posted
- No
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 17908406Soderstrom-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
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled Trial Comparing SET vs DET in an Oocyte Donation Programme
- ClinicalTrials.gov ID
- NCT01228474
- Acronym / sponsor ID
- DEX003
- Conditions
- Infertility, Oocyte Recipient, Single Embryo Transfer/Double Embryo Transfer, Cumulative Pregnancy Rate, Multiple Pregnancy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: 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
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Fundacion DexeusUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 26 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SET | Experimental | Other: Select the Number of embryos to transferSingle embryo transfer |
| DET | Active comparator | Other: Select the Number of embryos to transferDouble embryo transfer |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- medical indications to transfer only one embryo (Turner Syndrome, uterine surgical history, uterine myomas,…)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Select the Number of embryos to transferSelect the Number of embryos to transfer | Other | DET, SET |
Primary outcome
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
3 secondary outcomes
Cumulative live birth rate
Multiple pregnancy rate
Time needed to achieve the pregnancy
Results and safety
The study was stopped early (reason given: 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). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2015.
- Background: PubMed 17908406Soderstrom-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.
- Background: PubMed 12923139Soderstrom-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.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Select the Number of embryos to transfer in people with Infertility and Oocyte Recipient, run by Fundacion Dexeus at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 1 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: 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). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01228474, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2015; AzTrials last refreshed its copy on 31 Oct 2026.