InfertilityNCT03851536
Ultrasound Guidance for Embryo Transfer
A study testing Transvaginal Ultrasound Guided ET and Transabdominal Ultrasound Guided ET in people with Infertility, run by Menoufia University at 2 sites in Egypt.
Trial summary
Randomized controlled study comparing the TVUS versus TAUS guidance during the procedure of embryo transfer. Read more about this study
- Who is it for?
- Ages 20 to 42 years, women only
- Conditions the study is for
- Infertility
- What is being tested?
- Transvaginal Ultrasound Guided ET and Transabdominal Ultrasound Guided ET
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 2 sitesEgypt
- Study dates
- 2 Jun 2016to 9 Mar 2019
- Phase
- Interventional
- 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 20 to 42 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- All patients undergoing autologous ICSI and frozen embryo transfer (FET) cycles.
Who cannot join
- Cases of sever ovarian hyperstimulation requiring embryo cryopreservation
- Gestational surrogate cycles
- Oocyte donation cycles
- Very poor responders
- Patients with inadequate visualization of the uterus by ultrasound.
- Very difficult mock embryo transfer.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Alexandria University
Alexandria, 94109
Menoufia University
Shibīn al Kawm, Monofiya, 32511
About this study
Official title: Transvaginal Versus Transabdominal Ultrasound Guided Embryo Transfer. Randomized Controlled Trial.
Randomized controlled study comparing the TVUS versus TAUS guidance during the procedure of embryo transfer.
Read the detailed description
The aim of this study was to Compare between transvaginal and transabdominal ultrasound guided embryo transfer as regarding clinical pregnancy rate, patient comfort, time required for embryo transfer and endometrial visualization at time of embryo transfer.
- Conditions
- Infertility
- Being tested
- Transvaginal Ultrasound Guided ET, Transabdominal Ultrasound Guided ET
- Keywords
- Embryo Transfer, ICSI, Transvaginal Ultrasound
- Medical subject headings
- Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transvaginal Ultrasound Guided ETProcedure or surgery
Also called Transvaginal US guided ET
Use of TVUS to guide ET
Transabdominal Ultrasound Guided ETProcedure or surgery
Also called Transabdominal US guided ET
Use of TAUS to guide ET
| Study group | Role | What they receive |
|---|---|---|
| Transvaginal Ultrasound Guided ET | Experimental | Transvaginal ultrasound is used to guide ET Receives: Procedure: Transvaginal Ultrasound Guided ET |
| Transabdominal Ultrasound Guided ET | Experimental | Transabdominal ultrasound is used to guide ET Receives: Procedure: Transabdominal Ultrasound Guided ET |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical pregnancy
A clinical pregnancy is a pregnancy that is confirmed by ultrasonic visualization of gestational sac or heartbeat.
Measured: 3 weeks after Embryo transfer
Secondary outcomes (3)
Time required for ET
Time in seconds required for ET
Measured: Time from when the catheter is handed to the transferring physician to the time it is returned to the transferring embryologist.
Degree of cramping and pain
Degree of cramping and pain from 0 to 10 by visual analogue scale (VAS) where 0 is no pain and 10 unbearable pain.
Measured: During and immediately after ET
Endometrial visualization at time of embryo transfer
Endometrial visualization at time of embryo transfer by ultrasound
Measured: During ET
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2019
- Study start2 Jun 2016
- Primary completion15 Feb 2019
- Study completion9 Mar 2019
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 Menoufia UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Collaborators
- Alexandria University
- Responsible party
- Principal investigator, Haitham Aboali Hamza, Menoufia University
- Investigators
- Mohamad S kandil, MD, Study chair, Menoufia UniversitySherif S Gaafar, MD, Study director, Alexandria UniversityHaitham A Hamza, MD, Principal investigator, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03851536
- Sponsor's protocol ID
- MU179
- Status last verified
- Mar 2019
- First submitted
- 5 Feb 2019
- Last updated
- 12 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transvaginal Versus Transabdominal Ultrasound Guided Embryo Transfer. Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT03851536
- Acronym / sponsor ID
- MU179
- Conditions
- Infertility
- Keywords
- Embryo Transfer, ICSI, Transvaginal Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Collaborators
- Alexandria University
- Study start
- 2 Jun 2016 (actual)
- Primary completion
- 15 Feb 2019 (actual)
- Study completion
- 9 Mar 2019 (actual)
- First posted
- 22 Feb 2019 (actual)
- 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.
Randomized controlled study comparing the TVUS versus TAUS guidance during the procedure of embryo transfer.
Detailed description
The aim of this study was to Compare between transvaginal and transabdominal ultrasound guided embryo transfer as regarding clinical pregnancy rate, patient comfort, time required for embryo transfer and endometrial visualization at time of embryo transfer.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transvaginal Ultrasound Guided ET | Experimental | Procedure: Transvaginal Ultrasound Guided ETTransvaginal ultrasound is used to guide ET |
| Transabdominal Ultrasound Guided ET | Experimental | Procedure: Transabdominal Ultrasound Guided ETTransabdominal ultrasound is used to guide ET |
Who may qualify
- Ages
- 20 to 42 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- All patients undergoing autologous ICSI and frozen embryo transfer (FET) cycles.
Key exclusion criteria (6 listed)
- Cases of sever ovarian hyperstimulation requiring embryo cryopreservation
- Gestational surrogate cycles
- Oocyte donation cycles
- Very poor responders
- Patients with inadequate visualization of the uterus by ultrasound.
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 ETAlso: Transvaginal US guided ETUse of TVUS to guide ET | Procedure or surgery | Transvaginal Ultrasound Guided ET |
| Transabdominal Ultrasound Guided ETAlso: Transabdominal US guided ETUse of TAUS to guide ET | Procedure or surgery | Transabdominal Ultrasound Guided ET |
Primary outcome
Clinical pregnancy
Time frame: 3 weeks after Embryo transfer
A clinical pregnancy is a pregnancy that is confirmed by ultrasonic visualization of gestational sac or heartbeat.
3 secondary outcomes
Time required for ET
Time frame: Time from when the catheter is handed to the transferring physician to the time it is returned to the transferring embryologist.
Degree of cramping and pain
Time frame: During and immediately after ET
Endometrial visualization at time of embryo transfer
Time frame: During ET
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 12 Mar 2019.
- Individual participant dataSharing planned: No
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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.
Mohamad S kandil, MD study chair
Menoufia University
Sherif S Gaafar, MD study director
Alexandria University
Haitham A Hamza, MD principal investigator
Menoufia University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transvaginal Ultrasound Guided ET and Transabdominal Ultrasound Guided ET in people with Infertility, run by Menoufia University at 2 sites in Egypt.
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 6 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 12 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Egypt. 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?
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 (time frame: 3 weeks after 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 12 Mar 2019.