InfertilityeSETNCT01909570
eSET Plus Single Embryo Cryotransfer vs Double Embryo Transfer
A study testing Elective single embryo transfer and Double embryo transfer in people with Infertility and Pregnancy, Multiple, run by University Hospital Virgen de las Nieves at 1 site in Spain.
Trial summary
The purpose of this study is to determine whether a policy of elective single embryo transfer (eSET) plus single embryo cryotransfer is as effective as a double embryo transfer in terms of clinical pregnancy rate Read more about this study
- Who is it for?
- Ages 18 to 37 years, women only
- Conditions the study is for
- Infertility, Pregnancy, Multiple
- What is being tested?
- Elective single embryo transfer and Double embryo transfer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2010to Dec 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- women less tan 38 years
- women Body Mass Index (BMI) between 19-39 kg/m2
- Follicle-Stimulating Hormone (FSH) <15 mUI/mL on cycle third day
- First IVF/ICSI cycle or second after a positive pregnancy test in the first one
Who cannot join
- More tan five years of infertility
- Previous uterus surgery
- Uterus malformations
- More tan one miscarriage
Trial locations and contacts
1 site in 1 country.
Spain1 site
Unidad de gestión clínica de ginecología y obstetricia. Instituto Biosanitario de Granada.Hospital Universitario Virgen de las Nieves
Granada, 18014
About this study
Official title: Randomized Clinical Trial Comparing Elective Single Embryo Transfer Plus Single Embryo Cryotransfer vs Double Embryo Transfer
The purpose of this study is to determine whether a policy of elective single embryo transfer (eSET) plus single embryo cryotransfer is as effective as a double embryo transfer in terms of clinical pregnancy rate
Read the detailed description
The objective is to evaluate the In Vitro Fertilization/Intracytoplasmic Sperm Inyection (IVF/ICSI) results in terms of clinical pregnancy and multiple pregnancy rates, comparing elective single embryo transfer plus cryotransfer of one embryo if pregnancy is not achieved, with double embryo transfer.
This is a prospective randomized study, including couples arriving to the Reproductive Unit of the Hospital Universitario Virgen de las Nieves. All these patients had good reproductive prognosis and had been asigned randomly to one of the following groups: Group 1: elective single embryo transfer. In the case pregnancy is not achieved a cryotransfer of one embryo will be carried out. Group 2: elective double embryo transfer.
- Conditions
- Infertility, Pregnancy, Multiple
- Being tested
- Elective single embryo transfer, Double embryo transfer
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Elective single embryo transferProcedure or surgery
After the FIV/ICSI procedure, the embryo transfer in this arm would be of one embryo followed by the cryotransfer of one embryo in case of no conception in the fresh cycle.
Double embryo transferProcedure or surgery
After the FIV/ICSI procedure, the embryo transfer in this arm would be of two fresh embryos
| Study group | Role | What they receive |
|---|---|---|
| Elective single embryo transfer | Experimental | After the FIV/ICSI procedure, in this arm the embryo transfer would be of a single embryo followed by the cryotransfer or a single embryo in case of no fresh conception Receives: Procedure: Elective single embryo transfer |
| Double embryo transfer | Active comparator | After the FIV/ICSI procedure, in this arm the embryo transfer woub be of two fresh embryos Receives: Procedure: Double embryo transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Pregnancy Rate
A clinical pregnancy was defined by the presence of a gestational sac with heartbeat on transvaginal ultrasonography at the 7th weeks of pregnancy
Measured: Seven weeks after embryo transfer
Secondary outcomes (1)
Multiple Pregnancy Rate
A multiple clinical pregnancy was defined by the presence of more than one gestational sac with heartbeat on transvaginal ultrasonography at the 7th weeks of pregnancy
Measured: Seven weeks after embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2013 (estimated)
- Study startJan 2010
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 194 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Virgen de las Nieves
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Responsible party
- Principal investigator, Ana Clavero Gilabert, University Hospital Virgen de las Nieves
- Investigators
- Ana Clavero, PhD, Principal investigator, Investigator and laboratory specialist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01909570
- Sponsor's protocol ID
- FIS09/1968
- Acronym
- eSET
- Status last verified
- May 2024
- First submitted
- 24 Jul 2013
- Last updated
- 16 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Lopez-Regalado ML, Clavero A, Gonzalvo MC, Serrano M, Martinez L, Mozas J, Rodriguez-Serrano F, Fontes J, Castilla JA. Randomised clinical trial comparing elective single-embryo transfer followed by single-embryo cryotransfer versus double embryo transfer. Eur J Obstet Gynecol Reprod Biol. 2014 Jul;178:192-8. doi: 10.1016/j.ejogrb.2014.04.009. Epub 2014 Apr 19.
PubMed 24798072
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial Comparing Elective Single Embryo Transfer Plus Single Embryo Cryotransfer vs Double Embryo Transfer
- ClinicalTrials.gov ID
- NCT01909570
- Acronym / sponsor ID
- eSET / FIS09/1968
- Conditions
- Infertility, Pregnancy, Multiple
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 194 participants (actual)
- Lead sponsor
- University Hospital Virgen de las NievesUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III
- Study start
- Jan 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 26 Jul 2013 (estimated)
- Results
- Posted 20 Feb 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether a policy of elective single embryo transfer (eSET) plus single embryo cryotransfer is as effective as a double embryo transfer in terms of clinical pregnancy rate
Detailed description
The objective is to evaluate the In Vitro Fertilization/Intracytoplasmic Sperm Inyection (IVF/ICSI) results in terms of clinical pregnancy and multiple pregnancy rates, comparing elective single embryo transfer plus cryotransfer of one embryo if pregnancy is not achieved, with double embryo transfer.
This is a prospective randomized study, including couples arriving to the Reproductive Unit of the Hospital Universitario Virgen de las Nieves. All these patients had good reproductive prognosis and had been asigned randomly to one of the following groups: Group 1: elective single embryo transfer. In the case pregnancy is not achieved a cryotransfer of one embryo will be carried out. Group 2: elective double embryo transfer.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elective single embryo transfer | Experimental | Procedure: Elective single embryo transferAfter the FIV/ICSI procedure, in this arm the embryo transfer would be of a single embryo followed by the cryotransfer or a single embryo in case of no fresh conception |
| Double embryo transfer | Active comparator | Procedure: Double embryo transferAfter the FIV/ICSI procedure, in this arm the embryo transfer woub be of two fresh embryos |
Who may qualify
- Ages
- 18 to 37 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- women less tan 38 years
- women Body Mass Index (BMI) between 19-39 kg/m2
- Follicle-Stimulating Hormone (FSH) <15 mUI/mL on cycle third day
- First IVF/ICSI cycle or second after a positive pregnancy test in the first one
Key exclusion criteria (4 listed)
- More tan five years of infertility
- Previous uterus surgery
- Uterus malformations
- More tan one miscarriage
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 |
|---|---|---|
| Elective single embryo transferAfter the FIV/ICSI procedure, the embryo transfer in this arm would be of one embryo followed by the cryotransfer of one embryo in case of no conception in the fresh cycle. | Procedure or surgery | Elective single embryo transfer |
| Double embryo transferAfter the FIV/ICSI procedure, the embryo transfer in this arm would be of two fresh embryos | Procedure or surgery | Double embryo transfer |
Primary outcome
Clinical Pregnancy Rate
Time frame: Seven weeks after embryo transfer
A clinical pregnancy was defined by the presence of a gestational sac with heartbeat on transvaginal ultrasonography at the 7th weeks of pregnancy
1 secondary outcome
Multiple Pregnancy Rate
Time frame: Seven weeks after embryo transfer
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24798072Lopez-Regalado ML, Clavero A, Gonzalvo MC, Serrano M, Martinez L, Mozas J, Rodriguez-Serrano F, Fontes J, Castilla JA. Randomised clinical trial comparing elective single-embryo transfer followed by single-embryo cryotransfer versus double embryo transfer. Eur J Obstet Gynecol Reprod Biol. 2014 Jul;178:192-8. doi: 10.1016/j.ejogrb.2014.04.009. Epub 2014 Apr 19.
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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.
Ana Clavero, PhD principal investigator
Investigator and laboratory specialist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Elective single embryo transfer and Double embryo transfer in people with Infertility and Pregnancy, Multiple, run by University Hospital Virgen de las Nieves 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 4 inclusion and 4 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: finished, as of the sponsor's last update on 16 May 2024. 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?
Yes. Results are posted in the registry (first posted 20 Feb 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Clinical Pregnancy Rate (time frame: Seven weeks after embryo transfer). 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 NCT01909570, which also lists 1 linked publication.
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 16 May 2024.