In Vitro FertilizationPhase 1TVUSETNCT00826332
Transvaginal vs Transabdominal Ultrasound Guided Embryo Transfer
A Phase 1 study testing transabdominal ultrasound and transvaginal ultrasound in people with In Vitro Fertilization, run by Hadassah Medical Organization at 1 site in Israel.
Trial summary
Embryo transfer is the last step in the IVF process. it is now recognized that this step should be done carefully and that it affects success rates. in recent years, sonographic guidance appears to increase success rates. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- In Vitro Fertilization
- What is being tested?
- transabdominal ultrasound and transvaginal ultrasound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2009to Dec 2010
- Phase
- Phase 1
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- high quality embryos fro transfer
Who cannot join
- repeated IVF failure
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Hadassah University Hospital
Jerusalem, 91128
Ariel Revel, MD, 97226776424, arielr2@hadassah.org.il
About this study
Official title: Transvaginal or Transabdominal Ultrasound Guided Embryo Transfer- Which is Better?
Embryo transfer is the last step in the IVF process. it is now recognized that this step should be done carefully and that it affects success rates. in recent years, sonographic guidance appears to increase success rates.
Read the detailed description
Embryo transfer is the last step in the IVF process. it involves the insertion of a soft catheter through the uterine cervix. It is now recognized that this step should be done carefully and that it affects success rates. The embyos should be carefully deposited in the cavity. special care should be given to avoid touching the uterine fundus during the procedure. In recent years, sonographic guidance appears to increase success rates.
- Conditions
- In Vitro Fertilization
- Being tested
- transabdominal ultrasound, transvaginal ultrasound
- Keywords
- ultrasound, IVF, Embryo transfer, Pregnancy rate, female patient undergoing IVF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transabdominal ultrasoundProcedure or surgery
transabdominal ultrasound
transvaginal ultrasoundProcedure or surgery
transvaginal ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Abdominal | Active comparator | Transabdominal ultrasound guided embryo transfer Receives: Procedure: transabdominal ultrasound |
| Vaginal | Active comparator | Transvaginal ultrasound guided embryo transfer Receives: Procedure: transvaginal ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
pregnancy
Measured: 14 days
Secondary outcomes (1)
patient satisfaction
Measured: 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionDec 2009 (estimated)
- Study completionDec 2010 (estimated)
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 In Vitro FertilizationStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00826332
- Sponsor's protocol ID
- 0594-08-HMO-CTIL
- Acronym
- TVUSET
- Status last verified
- Jan 2009
- First submitted
- 21 Jan 2009
- Last updated
- 22 Jan 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sallam HN, Sadek SS. Ultrasound-guided embryo transfer: a meta-analysis of randomized controlled trials. Fertil Steril. 2003 Oct;80(4):1042-6. doi: 10.1016/s0015-0282(03)01009-4.
PubMed 14556831Karavani G, Ben-Meir A, Shufaro Y, Hyman JH, Revel A. Transvaginal ultrasound to guide embryo transfer: a randomized controlled trial. Fertil Steril. 2017 May;107(5):1159-1165. doi: 10.1016/j.fertnstert.2017.01.023. Epub 2017 Mar 24.
PubMed 28347493
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transvaginal or Transabdominal Ultrasound Guided Embryo Transfer- Which is Better?
- ClinicalTrials.gov ID
- NCT00826332
- Acronym / sponsor ID
- TVUSET / 0594-08-HMO-CTIL
- Conditions
- In Vitro Fertilization
- Keywords
- ultrasound, IVF, Embryo transfer, Pregnancy rate, female patient undergoing IVF
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2009 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 22 Jan 2009 (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.
Embryo transfer is the last step in the IVF process. it is now recognized that this step should be done carefully and that it affects success rates. in recent years, sonographic guidance appears to increase success rates.
Detailed description
Embryo transfer is the last step in the IVF process. it involves the insertion of a soft catheter through the uterine cervix. It is now recognized that this step should be done carefully and that it affects success rates. The embyos should be carefully deposited in the cavity. special care should be given to avoid touching the uterine fundus during the procedure. In recent years, sonographic guidance appears to increase success rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Abdominal | Active comparator | Procedure: transabdominal ultrasoundTransabdominal ultrasound guided embryo transfer |
| Vaginal | Active comparator | Procedure: transvaginal ultrasoundTransvaginal ultrasound guided embryo transfer |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- high quality embryos fro transfer
Key exclusion criteria (1 listed)
- repeated IVF failure
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 |
|---|---|---|
| transabdominal ultrasoundtransabdominal ultrasound | Procedure or surgery | Abdominal |
| transvaginal ultrasoundtransvaginal ultrasound | Procedure or surgery | Vaginal |
Primary outcome
pregnancy
Time frame: 14 days
1 secondary outcome
patient satisfaction
Time frame: 5 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2009.
- Background: PubMed 14556831Sallam HN, Sadek SS. Ultrasound-guided embryo transfer: a meta-analysis of randomized controlled trials. Fertil Steril. 2003 Oct;80(4):1042-6. doi: 10.1016/s0015-0282(03)01009-4.
- Derived from this study: PubMed 28347493Karavani G, Ben-Meir A, Shufaro Y, Hyman JH, Revel A. Transvaginal ultrasound to guide embryo transfer: a randomized controlled trial. Fertil Steril. 2017 May;107(5):1159-1165. doi: 10.1016/j.fertnstert.2017.01.023. Epub 2017 Mar 24.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing transabdominal ultrasound and transvaginal ultrasound in people with In Vitro Fertilization, run by Hadassah Medical Organization at 1 site in Israel.
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: status not confirmed, as of the sponsor's last update on 22 Jan 2009. 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 Israel. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ariel Revel, MD (97226776424, arielr2@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pregnancy (time frame: 14 days). 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 NCT00826332, 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 22 Jan 2009.