InfertilityNCT00682071
Ultrasound Guided Embryo Transfer: Abdominal Versus Transvaginal, a RCT
An observational study of Infertility and in Vitro Fertilization, run by University of Wisconsin, Madison.
Trial summary
Ultrasound (US) guided embryo transfer (ET) appears to improve pregnancy outcomes in IVF-ET. Most reports are done using a transabdominal (TAS) approach, in contrast to a transvaginal ultrasound (TVS) which does not require a full bladder. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infertility, in Vitro Fertilization
- How many people
- 224 participants
- Where
- No sites listed yet
- Study dates
- Aug 2003to Jun 2007
- Phase
- Observational
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients undergoing assisted reproductive cycles at the University of Wisconsin REI Program
Who may be able to join
- All patients undergoing assisted reproductive cycles including autologous IVF, oocyte donation, and frozen embryo transfer (FET) cycles
Who cannot join
- Cases of severe ovarian hyper-stimulation requiring embryo cryopreservation and gestational surrogate cycles
About this study
Official title: Abdominal Versus Transvaginal Ultrasound Guided Embryo Transfer: Results of a Randomized Clinical Trial
Ultrasound (US) guided embryo transfer (ET) appears to improve pregnancy outcomes in IVF-ET. Most reports are done using a transabdominal (TAS) approach, in contrast to a transvaginal ultrasound (TVS) which does not require a full bladder. We sought to determine if either approach was better with respect to clinical outcomes.
- Conditions
- Infertility, in Vitro Fertilization
- Keywords
- Ultrasound-guided, embryo transfer, in-vitro fertilization
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 1 | transabdominal ultrasound (TAS) guided embryo transfer | |
| 2 | transvaginal ultrasound (TVS) guided embryo transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
pregnancy rates for TAS and TVS ultrasound-guided ET groups
Measured: August 2003 to June 2007
Secondary outcomes (4)
Length of time required for embryo transfer
Measured: August 2003 to June 2007
differences between transferring physicians
Measured: August 2003 to June 2007
multiple pregnancies
Measured: August 2003 to June 2007
ectopic pregnancy rates
Measured: August 2003 to June 2007
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2008 (estimated)
- Study startAug 2003
- Primary completionJun 2007
- Study completionJun 2007
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.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Steven R Lindheim, MD, MMM, Principal investigator, Fertility Specialists Medical Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00682071
- Sponsor's protocol ID
- 2003-311
- Other IDs
- IRB# 2003-311 (UW), HSC# 2003-311 (UW), Grant: OB/GYN R&D, Funding # 133-FZ71
- Status last verified
- May 2008
- First submitted
- 16 May 2008
- Last updated
- 5 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abdominal Versus Transvaginal Ultrasound Guided Embryo Transfer: Results of a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT00682071
- Acronym / sponsor ID
- 2003-311
- Conditions
- Infertility, in Vitro Fertilization
- Keywords
- Ultrasound-guided, embryo transfer, in-vitro fertilization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Aug 2003
- Primary completion
- Jun 2007 (actual)
- Study completion
- Jun 2007 (actual)
- First posted
- 22 May 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.
Ultrasound (US) guided embryo transfer (ET) appears to improve pregnancy outcomes in IVF-ET. Most reports are done using a transabdominal (TAS) approach, in contrast to a transvaginal ultrasound (TVS) which does not require a full bladder. We sought to determine if either approach was better with respect to clinical outcomes.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –transabdominal ultrasound (TAS) guided embryo transfer |
| 2 | – | –transvaginal ultrasound (TVS) guided embryo transfer |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients undergoing assisted reproductive cycles at the University of Wisconsin REI Program
Key inclusion criteria (1 listed)
- All patients undergoing assisted reproductive cycles including autologous IVF, oocyte donation, and frozen embryo transfer (FET) cycles
Key exclusion criteria (1 listed)
- Cases of severe ovarian hyper-stimulation requiring embryo cryopreservation and gestational surrogate cycles
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
pregnancy rates for TAS and TVS ultrasound-guided ET groups
Time frame: August 2003 to June 2007
4 secondary outcomes
Length of time required for embryo transfer
Time frame: August 2003 to June 2007
differences between transferring physicians
Time frame: August 2003 to June 2007
multiple pregnancies
Time frame: August 2003 to June 2007
ectopic pregnancy rates
Time frame: August 2003 to June 2007
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 5 Oct 2015.
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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.
Steven R Lindheim, MD, MMM principal investigator
Fertility Specialists Medical Group
Questions about this trial
What is this clinical trial studying?
An observational study of Infertility and in Vitro Fertilization, run by University of Wisconsin, Madison.
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: finished, as of the sponsor's last update on 5 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
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 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?
pregnancy rates for TAS and TVS ultrasound-guided ET groups (time frame: August 2003 to June 2007). 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 5 Oct 2015.