MyomaMyo-BleedNCT07182045
Impact of Uterine and Ovarian Vessel Occlusion on Blood Loss in High Burden Minimally Invasive Myomectomy.
A study testing Temporary clamping of uterine and ovarian vessels in people with Myoma and Surgery, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
This study hypothesizes that temporary bilateral uterine and utero-ovarian artery occlusion with laparoscopic clamps at time of minimally invasive myomectomy will lead to a decreased blood loss at time of myomectomy compared to minimally invasive myomectomy without temporary occlusion. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- What is being tested?
- Temporary clamping of uterine and ovarian vessels
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Sep 2025to 30 Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient undergoing minimally invasive myomectomy with either a single intramural or Submucosal fibroid =/>5cm or
- Patients undergoing minimally invasive Myomectomy with =/> 5 fibroids
Who cannot join
- Pregnancy,
- Age <18yo,
- Patients undergoing concomitant surgery such as endometriosis surgery,
- Suspected malignancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Memorial Hermann Hospital
Houston, Texas, 77030
Randa Jalloul, MD, 713-486-7700, randa.j.jalloul@uth.tmc.edu
About this study
This study hypothesizes that temporary bilateral uterine and utero-ovarian artery occlusion with laparoscopic clamps at time of minimally invasive myomectomy will lead to a decreased blood loss at time of myomectomy compared to minimally invasive myomectomy without temporary occlusion.
Read the detailed description
Background: Leiomyomas are the most common benign tumor of the uterus and affect approximately 70-80% of the population with a uterus . Patients who opt to undergo treatment for a fibroid uterus have a variety of options including medical management, embolization, or surgical management; Historically surgical management involved hysterectomy; however, myomectomy has become more popular as a uterine sparing option. Current data supports that minimally invasive myomectomy is associated with lower morbidity and blood loss than traditional abdominal surgery. With advances in Minimally invasive myomectomy (MIS). There continues to be interest in methods to better improve intraoperative and postoperative outcomes. There is currently support for universal use of intramural vasopressin at time of myomectomy and a growing body of evidence to support temporary bilateral occlusion of the uterine and/or uteroovarian arteries at time of myomectomy to decrease blood loss.
High myoma burden is associated with an increased blood loss at time of surgical management.
Previous studies assessing the utility in temporary occlusion of the uterine and/or utero-ovarian vessels have not specifically evaluated the impact on high myoma burden individuals. As higher myoma burden is addressed in a minimally invasive fashion, it is important to specifically evaluate techniques to optimize these procedures. This study will specifically evaluate the effect of temporary bilateral uterine artery and utero-ovarian occlusion with laparoscopic clamps at the time of minimally invasive myomectomy.
- Being tested
- Temporary clamping of uterine and ovarian vessels
- Keywords
- myoma, blood loss
- Medical subject headings
- Myoma, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporary clamping of uterine and ovarian vesselsOther
Also called Vessel occlusion
Surgeon will temporarily clamp uterine and ovarian vessels.
| Study group | Role | What they receive |
|---|---|---|
| Temporary vessel clamps | Experimental | Use of temporary laparoscopic vessel clamps on uterine and ovarian vessels Receives: Other: Temporary clamping of uterine and ovarian vessels |
| No Temporary vessel clamps | No intervention | No use of vessel clamps |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated blood loss
Estimated blood loss during the surgery between groups, calculated by suction prior to irrigation.
Measured: Intraoperative (during surgery, which is < 24 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start18 Sep 2025
- Primary completion30 Sep 2028 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyomaStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Randa Jalloul, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07182045
- Sponsor's protocol ID
- HSC-MS-25-0413
- Acronym
- Myo-Bleed
- Status last verified
- May 2026
- First submitted
- 16 Sep 2025
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- 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 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Uterine and Ovarian Vessel Occlusion on Blood Loss in High Burden Minimally Invasive Myomectomy.
- ClinicalTrials.gov ID
- NCT07182045
- Acronym / sponsor ID
- Myo-Bleed / HSC-MS-25-0413
- Keywords
- myoma, blood loss
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- 18 Sep 2025 (actual)
- Primary completion
- 30 Sep 2028 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 19 Sep 2025 (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.
This study hypothesizes that temporary bilateral uterine and utero-ovarian artery occlusion with laparoscopic clamps at time of minimally invasive myomectomy will lead to a decreased blood loss at time of myomectomy compared to minimally invasive myomectomy without temporary occlusion.
Detailed description
Background: Leiomyomas are the most common benign tumor of the uterus and affect approximately 70-80% of the population with a uterus . Patients who opt to undergo treatment for a fibroid uterus have a variety of options including medical management, embolization, or surgical management; Historically surgical management involved hysterectomy; however, myomectomy has become more popular as a uterine sparing option. Current data supports that minimally invasive myomectomy is associated with lower morbidity and blood loss than traditional abdominal surgery. With advances in Minimally invasive myomectomy (MIS). There continues to be interest in methods to better improve intraoperative and postoperative outcomes. There is currently support for universal use of intramural vasopressin at time of myomectomy and a growing body of evidence to support temporary bilateral occlusion of the uterine and/or uteroovarian arteries at time of myomectomy to decrease blood loss.
High myoma burden is associated with an increased blood loss at time of surgical management.
Previous studies assessing the utility in temporary occlusion of the uterine and/or utero-ovarian vessels have not specifically evaluated the impact on high myoma burden individuals. As higher myoma burden is addressed in a minimally invasive fashion, it is important to specifically evaluate techniques to optimize these procedures. This study will specifically evaluate the effect of temporary bilateral uterine artery and utero-ovarian occlusion with laparoscopic clamps at the time of minimally invasive myomectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Temporary vessel clamps | Experimental | Other: Temporary clamping of uterine and ovarian vesselsUse of temporary laparoscopic vessel clamps on uterine and ovarian vessels |
| No Temporary vessel clamps | No intervention | –No use of vessel clamps |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patient undergoing minimally invasive myomectomy with either a single intramural or Submucosal fibroid =/>5cm or
- Patients undergoing minimally invasive Myomectomy with =/> 5 fibroids
Key exclusion criteria (4 listed)
- Pregnancy,
- Age <18yo,
- Patients undergoing concomitant surgery such as endometriosis surgery,
- Suspected malignancy
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 |
|---|---|---|
| Temporary clamping of uterine and ovarian vesselsAlso: Vessel occlusionSurgeon will temporarily clamp uterine and ovarian vessels. | Other | Temporary vessel clamps |
Primary outcome
Estimated blood loss
Time frame: Intraoperative (during surgery, which is < 24 hours)
Estimated blood loss during the surgery between groups, calculated by suction prior to irrigation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: No
Related trials for Myoma
RecruitingObservational study
Association of Ultrasound Features of the Myometrium Suggestive of Adenomyosis and Clinical Symptoms
Adenomyosis of Uterus
RecruitingPhase 4
Prescription of Letrozole for Uterine Myoma
Leiomyoma, Uterine, Leiomyoma
Recruiting
Prevention of Intra-uterine Adhesions Following Laparoscopic and Laparotomic Myomectomy
Myoma
Not yet recruitingObservational study
Prospective Perioperative Clinical Registry for Women Undergoing Benign Gynecological Surgery
Benign Gynecological Disease, Uterine Fibroids
Not yet recruiting
Terlipressin vs Placebo to Reduce Bleeding in Fibroid Surgery
Uterine Fibroids (Leiomyoma), Uterine Myoma
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Temporary clamping of uterine and ovarian vessels in people with Myoma and Surgery, run by The University of Texas Health Science Center, Houston at 1 site in United States.
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 2 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 14 May 2026. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Randa Jalloul, MD (3137128603, randa.j.jalloul@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Estimated blood loss (time frame: Intraoperative (during surgery, which is < 24 hours)). 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 14 May 2026.