InfertilityNCT00814398
Single Embryo Transfer Versus Double Embryo Transfer
A study testing Double Embryo Transfer (DET) and Single Embryo Transfer (SET) in people with Infertility, run by Vida Recoletas Sevilla at 1 site in Spain.
Trial summary
The aim of this project is to study the best number (1 or 2)and day (3 vs 5)of embryo transfer in good prognosis patient. Read more about this study
- Who is it for?
- Ages 18 to 37 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Double Embryo Transfer (DET) and Single Embryo Transfer (SET)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 199 participants
- Where
- 1 siteSpain
- Study dates
- Dec 2008to Sep 2009
- 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 37 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Good prognosis IVF patients
Who cannot join
- Bad prognosis IVF patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Single Embryo Transfer Versus Double Embryo Transfer in Day 3 or Blastocyst Stage
The aim of this project is to study the best number (1 or 2)and day (3 vs 5)of embryo transfer in good prognosis patient.
- Conditions
- Infertility
- Being tested
- Double Embryo Transfer (DET), Single Embryo Transfer (SET)
- Keywords
- Infertility, IVF, SET, DET, Blastocyst
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double Embryo Transfer (DET)Procedure or surgery
Two embryos are transferred during an IVF treatment
Single Embryo Transfer (SET)Procedure or surgery
A single embryo is transferred during an IVF treatment
| Study group | Role | What they receive |
|---|---|---|
| SET on day 3 | Experimental | Single embryo transfer on day 3 of embryo development Receives: Procedure: Single Embryo Transfer (SET) |
| DET on day 3 | Experimental | Double embryo transfer on day 3 of embryo development Receives: Procedure: Double Embryo Transfer (DET) |
| SET on day 5 | Experimental | Single embryo transfer on day 5 of embryo development Receives: Procedure: Single Embryo Transfer (SET) |
| DET on day 5 | Experimental | Double embryo transfer on day 5 of embryo development Receives: Procedure: Double Embryo Transfer (DET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Live-birth delivery rate
Measured: End of pregnancy (nine months after last transfer)
Secondary outcomes (2)
Multiple live-birth rate
Measured: End of pregnancy (nine months after last transfer)
Acceptance of assigned randomised group
Measured: Day of randomisation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionSep 2009
- Study completionSep 2009
Why it stopped: Change in cryopreservation protocol
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 199 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vida Recoletas Sevilla
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuel Fernandez-Sanchez, Vida Recoletas Sevilla
- Investigators
- Manuel Fernandez, MD, Principal investigator, Vida Recoletas Sevilla
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00814398
- Sponsor's protocol ID
- IVISEV-002SET
- Status last verified
- Mar 2011
- First submitted
- 23 Dec 2008
- Last updated
- 18 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Embryo Transfer Versus Double Embryo Transfer in Day 3 or Blastocyst Stage
- ClinicalTrials.gov ID
- NCT00814398
- Acronym / sponsor ID
- IVISEV-002SET
- Conditions
- Infertility
- Keywords
- Infertility, IVF, SET, DET, Blastocyst
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Change in cryopreservation protocol
- Enrolment
- 199 participants (actual)
- Lead sponsor
- Vida Recoletas SevillaUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 24 Dec 2008 (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.
The aim of this project is to study the best number (1 or 2)and day (3 vs 5)of embryo transfer in good prognosis patient.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| SET on day 3 | Experimental | Procedure: Single Embryo Transfer (SET)Single embryo transfer on day 3 of embryo development |
| DET on day 3 | Experimental | Procedure: Double Embryo Transfer (DET)Double embryo transfer on day 3 of embryo development |
| SET on day 5 | Experimental | Procedure: Single Embryo Transfer (SET)Single embryo transfer on day 5 of embryo development |
| DET on day 5 | Experimental | Procedure: Double Embryo Transfer (DET)Double embryo transfer on day 5 of embryo development |
Who may qualify
- Ages
- 18 to 37 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Good prognosis IVF patients
Key exclusion criteria (1 listed)
- Bad prognosis IVF patients
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 |
|---|---|---|
| Double Embryo Transfer (DET)Two embryos are transferred during an IVF treatment | Procedure or surgery | DET on day 3, DET on day 5 |
| Single Embryo Transfer (SET)A single embryo is transferred during an IVF treatment | Procedure or surgery | SET on day 3, SET on day 5 |
Primary outcome
Live-birth delivery rate
Time frame: End of pregnancy (nine months after last transfer)
2 secondary outcomes
Multiple live-birth rate
Time frame: End of pregnancy (nine months after last transfer)
Acceptance of assigned randomised group
Time frame: Day of randomisation
Results and safety
The study was stopped early (reason given: Change in cryopreservation protocol). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2016.
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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.
Manuel Fernandez, MD principal investigator
Vida Recoletas Sevilla
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Double Embryo Transfer (DET) and Single Embryo Transfer (SET) in people with Infertility, run by Vida Recoletas Sevilla 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 1 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 18 Jan 2016. 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: Change in cryopreservation protocol). 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?
Live-birth delivery rate (time frame: End of pregnancy (nine months after last transfer)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jan 2016.