InfertilityPhase 4NCT01137461
Efficacy of Embryo Transfer Procedure Guided by Transvaginal Ultrasound Versus Abdominal Ultrasound in Oocytes Recipients
A Phase 4 study testing ultrasound-guided embryo transfer in people with Infertility, run by Fundació Privada Eugin at 1 site in Spain.
Trial summary
The objective of this study is to evaluate the efficacy of embryo transfer procedure guided by transvaginal ultrasound versus abdominal ultrasound in recipients of oocytes as well as the advantages and disadvantages of the new technique. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility
- What is being tested?
- ultrasound-guided embryo transfer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteSpain
- Study dates
- Jun 2010to Oct 2010
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Oocyte recipients.
- Uterus without previously detected anomalies.
- Patients able to understand the study requirements who want to participate during all its duration and that have signed the informed consent.
Who cannot join
- Turner syndrome, Black race (significantly lower implantational rates)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Efficacy of Embryo Transfer Procedure Guided by Transvaginal Ultrasound Versus Abdominal Ultrasound in Recipients of Oocytes. A Single-centre, Randomized Clinical Trial.
The objective of this study is to evaluate the efficacy of embryo transfer procedure guided by transvaginal ultrasound versus abdominal ultrasound in recipients of oocytes as well as the advantages and disadvantages of the new technique.
- Conditions
- Infertility
- Being tested
- ultrasound-guided embryo transfer
- Keywords
- Female infertility with indication of oocyte reception
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound-guided embryo transferProcedure or surgery
Embryo transfer in oocyte recipients
| Study group | Role | What they receive |
|---|---|---|
| abdominal ultrasound | Other | traditional technique Receives: Procedure: ultrasound-guided embryo transfer |
| transvaginal ultrasound | Other | new technique Receives: Procedure: ultrasound-guided embryo transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy rate
Evidence of gestational sac by transvaginal ultrasound
Measured: 40 days 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 posted4 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionOct 2010
- Study completionOct 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundació Privada Eugin
- Sponsor type
- University, hospital or other
- Investigators
- Daniel Bodri, Principal investigator, Clinica EUGIN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01137461
- Sponsor's protocol ID
- TATV
- Status last verified
- Apr 2011
- First submitted
- 3 Jun 2010
- Last updated
- 14 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Bodri D, Colodron M, Garcia D, Obradors A, Vernaeve V, Coll O. Transvaginal versus transabdominal ultrasound guidance for embryo transfer in donor oocyte recipients: a randomized clinical trial. Fertil Steril. 2011 Jun;95(7):2263-8, 2268.e1. doi: 10.1016/j.fertnstert.2011.03.028. Epub 2011 Apr 2.
PubMed 21459374
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy of Embryo Transfer Procedure Guided by Transvaginal Ultrasound Versus Abdominal Ultrasound in Recipients of Oocytes. A Single-centre, Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT01137461
- Acronym / sponsor ID
- TATV
- Conditions
- Infertility
- Keywords
- Female infertility with indication of oocyte reception
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Fundació Privada EuginUniversity, hospital or other
- Study start
- Jun 2010
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 4 Jun 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.
The objective of this study is to evaluate the efficacy of embryo transfer procedure guided by transvaginal ultrasound versus abdominal ultrasound in recipients of oocytes as well as the advantages and disadvantages of the new technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| abdominal ultrasound | Other | Procedure: ultrasound-guided embryo transfertraditional technique |
| transvaginal ultrasound | Other | Procedure: ultrasound-guided embryo transfernew technique |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Oocyte recipients.
- Uterus without previously detected anomalies.
- Patients able to understand the study requirements who want to participate during all its duration and that have signed the informed consent.
Key exclusion criteria (1 listed)
- Turner syndrome, Black race (significantly lower implantational rates)
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 |
|---|---|---|
| ultrasound-guided embryo transferEmbryo transfer in oocyte recipients | Procedure or surgery | abdominal ultrasound, transvaginal ultrasound |
Primary outcome
Clinical pregnancy rate
Time frame: 40 days after embryo transfer
Evidence of gestational sac by transvaginal ultrasound
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2011.
- Results publication: PubMed 21459374Bodri D, Colodron M, Garcia D, Obradors A, Vernaeve V, Coll O. Transvaginal versus transabdominal ultrasound guidance for embryo transfer in donor oocyte recipients: a randomized clinical trial. Fertil Steril. 2011 Jun;95(7):2263-8, 2268.e1. doi: 10.1016/j.fertnstert.2011.03.028. Epub 2011 Apr 2.
- Clínica EUGINLink 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.
Daniel Bodri principal investigator
Clinica EUGIN
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ultrasound-guided embryo transfer in people with Infertility, run by Fundació Privada Eugin 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: finished, as of the sponsor's last update on 14 Apr 2011. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: 40 days 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 NCT01137461, 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 14 Apr 2011.