Other Abnormal Uterine and Vaginal BleedingPhase 1/2NCT05423067
Permanent Occlusion of Uteine Arteies in Management of Abnormal Uterine Bleeding
A Phase 1/2 study testing bilateral permanent occlusion of uterine arteries in people with Other Abnormal Uterine and Vaginal Bleeding, run by Mansoura Integrated Fertility Center at 1 site in Egypt.
Trial summary
Prospective observational interventional study , The study done in two phases: 1. Phase one from October 2011to May 2012 pilot study including twenty nine (29) premenopausal patients followed up for six months 2. Phase two from October 2012 till May 2014. Read more about this study
- Who is it for?
- Ages 34 to 45 years, women only
- Conditions the study is for
- Other Abnormal Uterine and Vaginal Bleeding
- What is being tested?
- bilateral permanent occlusion of uterine arteries
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2011to May 2015
- Phase
- Phase 1/2
- 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 34 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- premenopausal with abnormal uterine bleeding and completed their families having normal endometrium (biopsy in preceding 6 months ) and may have uterine intramural myomas not exceeding 150 ml in volume and away from uterine cavity by at least 1cm and /or adenomyosis
Who cannot join
- patients wishing future fertility
- endometrial sampling not done or more than 6 months or myoma encroaching or distorting cavity or larger than 150 ml in volume
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interventional Gynecologic Surgery
Prospective observational interventional study , The study done in two phases:
- Phase one from October 2011to May 2012 pilot study including twenty nine (29) premenopausal patients followed up for six months
- Phase two from October 2012 till May 2014. Including Eighty nine (89) premenopausal patients all of them needing to preserve their uteri.
Read the detailed description
Abstract Objectives: To assess the effectiveness of permanent bilateral occlusion of uterine arteries in treatment of abnormal uterine bleeding.
Design: prospective observational study Setting: Done in Mansoura university hospital, department of Obstetrics and gynecology.
Patients and Methods: The study done in two phases:
- Phase one from October 2011to May 2012 pilot study including twenty nine (29) premenopausal patients followed up for six months
- Phase two from October 2012 till May 2014. Including Eighty nine (89) premenopausal patients all of them needing to preserve their uteri.
Results: Results are hopeful and courageous in phase one as regards patients satisfaction, Quality of life and improvements of bleeding. Results of phase two will be implemented, analyzed and presented in tables. All data will be statistically analyzed and the results will be presented after completion of eighteen (18) months follow up to rule out any bias and/ or errors in the results.
Conclusion: permanent bilateral uterine arteries occlusion may be a good alternative to radical surgery in abnormal uterine bleeding.
- Being tested
- bilateral permanent occlusion of uterine arteries
- Keywords
- permenant occlusion, uterine bleeding, uterine arteries
- Medical subject headings
- Uterine Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bilateral permanent occlusion of uterine arteriesProcedure or surgery
bilateral permanent Occlusion of uterine arteries through abdominal route
| Study group | Role | What they receive |
|---|---|---|
| BUAO | Other | The study done in two phases:
1. Phase one from October 2011to May 2012 pilot study including twenty nine (29) premenopausal patients followed up for six months
2. Phase two from October 2012 till May 2014. Including Eighty nine (89) premenopausal patients Receives: Procedure: bilateral permanent occlusion of uterine arteries |
What is being measured
The primary outcome is the main question the study is designed to answer.
uterine bleeding
Measured: October 2011 till January 2016
Secondary outcomes (2)
patient satisfaction
Measured: october 2011 - may 2015
quality of life
Measured: october 2011 - may 2015
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study startOct 2011
- Primary completionOct 2012
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Other Abnormal Uterine and Vaginal BleedingStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura Integrated Fertility Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emad Mohamad Sedeek, Mansoura Integrated Fertility Center
- Investigators
- Adel S Helal, MD, Principal investigator, Mansoura Integrated Fertility Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05423067
- Sponsor's protocol ID
- Adelhelal
- Status last verified
- Jun 2022
- First submitted
- 9 Dec 2015
- Last updated
- 21 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional Gynecologic Surgery
- ClinicalTrials.gov ID
- NCT05423067
- Acronym / sponsor ID
- Adelhelal
- Keywords
- permenant occlusion, uterine bleeding, uterine arteries
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Mansoura Integrated Fertility CenterUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 21 Jun 2022 (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.
Prospective observational interventional study , The study done in two phases:
- Phase one from October 2011to May 2012 pilot study including twenty nine (29) premenopausal patients followed up for six months
- Phase two from October 2012 till May 2014. Including Eighty nine (89) premenopausal patients all of them needing to preserve their uteri.
Detailed description
Abstract Objectives: To assess the effectiveness of permanent bilateral occlusion of uterine arteries in treatment of abnormal uterine bleeding.
Design: prospective observational study Setting: Done in Mansoura university hospital, department of Obstetrics and gynecology.
Patients and Methods: The study done in two phases:
- Phase one from October 2011to May 2012 pilot study including twenty nine (29) premenopausal patients followed up for six months
- Phase two from October 2012 till May 2014. Including Eighty nine (89) premenopausal patients all of them needing to preserve their uteri.
Results: Results are hopeful and courageous in phase one as regards patients satisfaction, Quality of life and improvements of bleeding. Results of phase two will be implemented, analyzed and presented in tables. All data will be statistically analyzed and the results will be presented after completion of eighteen (18) months follow up to rule out any bias and/ or errors in the results.
Conclusion: permanent bilateral uterine arteries occlusion may be a good alternative to radical surgery in abnormal uterine bleeding.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BUAO | Other | Procedure: bilateral permanent occlusion of uterine arteriesThe study done in two phases: 1. Phase one from October 2011to May 2012 pilot study including twenty nine (29) premenopausal patients followed up for six months 2. Phase two from October 2012 till May 2014. Including Eighty nine (89) premenopausal patients |
Who may qualify
- Ages
- 34 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- premenopausal with abnormal uterine bleeding and completed their families having normal endometrium (biopsy in preceding 6 months ) and may have uterine intramural myomas not exceeding 150 ml in volume and away from uterine cavity by at least 1cm and /or adenomyosis
Key exclusion criteria (2 listed)
- patients wishing future fertility
- endometrial sampling not done or more than 6 months or myoma encroaching or distorting cavity or larger than 150 ml in volume
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 |
|---|---|---|
| bilateral permanent occlusion of uterine arteriesbilateral permanent Occlusion of uterine arteries through abdominal route | Procedure or surgery | BUAO |
Primary outcome
uterine bleeding
Time frame: October 2011 till January 2016
2 secondary outcomes
patient satisfaction
Time frame: october 2011 - may 2015
quality of life
Time frame: october 2011 - may 2015
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 21 Jun 2022.
- Individual participant dataSharing planned: Undecided
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.
Adel S Helal, MD principal investigator
Mansoura Integrated Fertility Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing bilateral permanent occlusion of uterine arteries in people with Other Abnormal Uterine and Vaginal Bleeding, run by Mansoura Integrated Fertility Center at 1 site 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 2 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 21 Jun 2022. 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 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.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
uterine bleeding (time frame: October 2011 till January 2016). 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 21 Jun 2022.