InfertilityEarly Phase 1NCT01805505
Comparison of Embryo Transfer in Egg Donation Recipients With Transvaginal and Transabdominal Ultrasound
A Early Phase 1 study testing Transvaginal ultrasound-guided embryo transfer and Transabdominal ultrasound-guided embryo transfer in people with Infertility, run by IVI Madrid at 1 site in Spain.
Trial summary
Transabdominal ultrasound guidance is the golden standard for embryo transfers. Transvaginal ultrasound guidance was proposed recently to provide better visualization and reduce patient discomfort as embryo transfer can be performed with an empty bladder in this case. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Transvaginal ultrasound-guided embryo transfer and Transabdominal ultrasound-guided embryo transfer
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 346 participants
- Where
- 1 siteSpain
- Study dates
- Feb 2012to Dec 2016
- Phase
- Early 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 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Patients undergoing oocyte donation treatment with transfer of 2 embryos on day 3
Who cannot join
- Submucous or >3 cm intramural fibroids
- Turner syndrome
- Black recipients
Trial locations and contacts
1 site in 1 country.
About this study
Transabdominal ultrasound guidance is the golden standard for embryo transfers. Transvaginal ultrasound guidance was proposed recently to provide better visualization and reduce patient discomfort as embryo transfer can be performed with an empty bladder in this case. The purpose of this study is to determine whether there are any differences between transvaginal and transabdominal ultrasound-guided embryo transfer in terms of ease of use, patient satisfaction, and treatment outcome.
- Conditions
- Infertility
- Being tested
- Transvaginal ultrasound-guided embryo transfer, Transabdominal ultrasound-guided embryo transfer
- Keywords
- Female infertility, Oocyte donation, Embryo transfer, Transvaginal ultrasonography, Transabdominal ultrasonography
- Medical subject headings
- Infertility, Infertility, Female
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transvaginal ultrasound-guided embryo transferProcedure or surgery
Also called Kitazato Long ET catheter (Kitazato Medical Co. Ltd., Tokyo, Japan)
Embryo transfer of two day-3 embryos performed with the Kitazato Long ET catheter (Kitazato Medical Co. Ltd., Tokyo, Japan), guided by transvaginal ultrasound
Transabdominal ultrasound-guided embryo transferProcedure or surgery
Also called Cook Soft-Trans ET catheter (Cook Medical Inc., Bloomington, IN, USA)
Embryo transfer of two day-3 embryos performed with the Cook Soft-Trans ET catheter (Cook Medical Inc., Bloomington, IN, USA), guided by transabdominal ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Transvaginal ultrasound-guided embryo transfer | Experimental | Transvaginal ultrasound-guided transfer of two day-3 embryos Receives: Procedure: Transvaginal ultrasound-guided embryo transfer |
| Transabdominal ultrasound-guided embryo transfer | Active comparator | Transabdominal ultrasound-guided transfer of two day-3 embryos Receives: Procedure: Transabdominal ultrasound-guided embryo transfer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy rate
Proportion of patients with a positive pregnancy test
Measured: At performing the pregnancy test 11 days post-embryo transfer
Secondary outcomes (8)
Clinical pregnancy rate
Proportion of patients with at least one gestational sac at first pregnancy ultrasound
Measured: At first pregnancy ultrasound (3 weeks post-embryo transfer)
Ongoing pregnancy rate
Proportion of patients with at least one live intrauterine fetus at 10 weeks post-embryo transfer
Measured: At 10 weeks post-embryo transfer
Menstruation-like pain
Measured on a three-level scale (none/mild/strong)
Measured: At embryo transfer
Discomfort related to vesical distension
Measured on a three-level scale (none/mild/strong)
Measured: At embryo transfer
Overall discomfort
Measured on a three-level scale (none/mild/strong)
Measured: At embryo transfer
Difficulty using the assigned technique faced by operators
Measured on a three-level scale (easy/moderately difficult/very difficult)
Measured: At embryo transfer
Catheterization time
Measured: At embryo transfer
Conversion to the opposite technique
Proportion of cases in which embryo transfer was performed using the technique of the opposite randomization arm (i.e., proportion of patients randomized to have transabdominal ultrasound-guided transfer in whom transvaginal ultrasound-guided was performed, and the other way around)
Measured: At embryo transfer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2013 (estimated)
- Study startFeb 2012
- Primary completionDec 2016
- Study completionDec 2016
Why it stopped: slow recruitment rate
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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 346 participants (actual)
Sponsor and investigators
- Lead sponsor
- IVI Madrid
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erik E Hauzman, MD, PhD, Principal investigator, IVI MadridJuan A Garcia-Velasco, MD, PhD, Study director, IVI Madrid
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01805505
- Sponsor's protocol ID
- MAD-EH-01-2012-01
- Status last verified
- Mar 2017
- First submitted
- 1 Mar 2013
- Last updated
- 7 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Embryo Transfer in Egg Donation Recipients With Transvaginal and Transabdominal Ultrasound
- ClinicalTrials.gov ID
- NCT01805505
- Acronym / sponsor ID
- MAD-EH-01-2012-01
- Conditions
- Infertility
- Keywords
- Female infertility, Oocyte donation, Embryo transfer, Transvaginal ultrasonography, Transabdominal ultrasonography
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow recruitment rate
- Enrolment
- 346 participants (actual)
- Lead sponsor
- IVI MadridUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 6 Mar 2013 (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.
Transabdominal ultrasound guidance is the golden standard for embryo transfers. Transvaginal ultrasound guidance was proposed recently to provide better visualization and reduce patient discomfort as embryo transfer can be performed with an empty bladder in this case. The purpose of this study is to determine whether there are any differences between transvaginal and transabdominal ultrasound-guided embryo transfer in terms of ease of use, patient satisfaction, and treatment outcome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transvaginal ultrasound-guided embryo transfer | Experimental | Procedure: Transvaginal ultrasound-guided embryo transferTransvaginal ultrasound-guided transfer of two day-3 embryos |
| Transabdominal ultrasound-guided embryo transfer | Active comparator | Procedure: Transabdominal ultrasound-guided embryo transferTransabdominal ultrasound-guided transfer of two day-3 embryos |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients undergoing oocyte donation treatment with transfer of 2 embryos on day 3
Key exclusion criteria (3 listed)
- Submucous or >3 cm intramural fibroids
- Turner syndrome
- Black recipients
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 |
|---|---|---|
| Transvaginal ultrasound-guided embryo transferAlso: Kitazato Long ET catheter (Kitazato Medical Co. Ltd., Tokyo, Japan)Embryo transfer of two day-3 embryos performed with the Kitazato Long ET catheter (Kitazato Medical Co. Ltd., Tokyo, Japan), guided by transvaginal ultrasound | Procedure or surgery | Transvaginal ultrasound-guided embryo transfer |
| Transabdominal ultrasound-guided embryo transferAlso: Cook Soft-Trans ET catheter (Cook Medical Inc., Bloomington, IN, USA)Embryo transfer of two day-3 embryos performed with the Cook Soft-Trans ET catheter (Cook Medical Inc., Bloomington, IN, USA), guided by transabdominal ultrasound | Procedure or surgery | Transabdominal ultrasound-guided embryo transfer |
Primary outcome
Pregnancy rate
Time frame: At performing the pregnancy test 11 days post-embryo transfer
Proportion of patients with a positive pregnancy test
8 secondary outcomes
Clinical pregnancy rate
Time frame: At first pregnancy ultrasound (3 weeks post-embryo transfer)
Ongoing pregnancy rate
Time frame: At 10 weeks post-embryo transfer
Menstruation-like pain
Time frame: At embryo transfer
Discomfort related to vesical distension
Time frame: At embryo transfer
Overall discomfort
Time frame: At embryo transfer
Difficulty using the assigned technique faced by operators
Time frame: At embryo transfer
Catheterization time
Time frame: At embryo transfer
Conversion to the opposite technique
Time frame: At embryo transfer
Results and safety
The study was stopped early (reason given: slow recruitment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2017.
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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.
Erik E Hauzman, MD, PhD principal investigator
IVI Madrid
Juan A Garcia-Velasco, MD, PhD study director
IVI Madrid
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Transvaginal ultrasound-guided embryo transfer and Transabdominal ultrasound-guided embryo transfer in people with Infertility, run by IVI Madrid 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 3 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 7 Mar 2017. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 was stopped early (reason given: slow recruitment rate). 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?
Pregnancy rate (time frame: At performing the pregnancy test 11 days post-embryo 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 7 Mar 2017; AzTrials last refreshed its copy on 7 Nov 2026.