Uterine Fibroids (Leiomyoma)NCT07352761
Bilateral Uterine Artery Occlusion During Laparoscopic Myomectomy
A study testing Temporary clipping of uterine artery, Temporary occlusive suturing of uterine artery and Bipolar coagulation of uterine arteries in people with Uterine Fibroids (Leiomyoma) and Myomectomy, run by Alexandria University at 2 sites in Egypt.
Trial summary
The current study is a multiple-arm, single blinded, and controlled randomized trial. It will be conducted in two gynecological endoscopy centers: • ElShatby University Hospital, a tertiary level hospital in Alexandria, Egypt. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Uterine Fibroids (Leiomyoma), Myomectomy, Myomectomy; Surgical Blood Loss
- What is being tested?
- Temporary clipping of uterine artery, Temporary occlusive suturing of uterine artery and Bipolar coagulation of uterine arteries
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 May 2025to 25 Feb 2026
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- women with uterine fibroids and complaining of either abnormal uterine bleeding, infertility, urinary or rectosigmoid pressure manifestations.
- Fibroid size from 3 - 10 cm in diameter and with
- a maximum number of 3 fibroids.
Who cannot join
- contraindication to pneumoperitoneum and laparoscopy,
- patients with BMI > 30 kg/m2,
- history of midline abdominal incisions,
- women with history of prior ovarian surgery,
- women with history of hormonal treatment for the last 3 months before surgery,
- women who are not good candidate for myomectomy and who would benefit more from hysterectomy such as, women with multiple ≥ 4 leiomyomata, associated adenomyosis, recurrent fibroids after myomectomy.
- suspected endometrial malignancy or suspected leiomyosarcoma features on ultrasound and/or MRI.
- Submucous fibroids who will undergo hysteroscopic myomectomy beside the laparoscopic surgery.
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Department of Obstetrics and Gynecology, Faculty of Medicine, Alexandria Univeristy
Alexandria, El-Shatby, 21723
• Al-Madina Women Hospital, A specialized hospital of Obstetrics and Gynecology, Alexandria, Egypt.
Alexandria, Smouha
About this study
Official title: Comparing Different Techniques of Bilateral Uterine Artery Occlusion During Laparoscopic Myomectomy: A Randomized Controlled Trial
The current study is a multiple-arm, single blinded, and controlled randomized trial. It will be conducted in two gynecological endoscopy centers: • ElShatby University Hospital, a tertiary level hospital in Alexandria, Egypt. • Al-Madina Women Hospital, A specialized hospital of Obstetrics and Gynecology, Alexandria, Egypt. Patient selection: women with uterine leiomyomata and planning for laparoscopic myomectomy will be assessed for eligibility then will be enrolled in the trial according to the following inclusion and exclusion criteria, after providing a written informed consent of participation. Outcome variables of the study: The primary outcome is intraoperative blood loss and the change in postoperative hemoglobin. The secondary outcomes of this study are the operative time of performing uterine arteries occlusion and the postoperative ovarian reserve.
Read the detailed description
The goal of this clinical trial is to evaluate the safety and impact on ovarian reserve of different techniques of bilateral uterine artery occlusion in women in the reproductive age group scheduled for laparoscopic myomectomy. The main question[s] it aims to answer [is/are]:Do the different techniques for laparoscopic uterine artery occlusion prior to myomectomy decrease the intraoperative blood loss and the postoperative hemoglobin? The investigator intends to compare three different techniques for laparoscopic uterine artery occlusion (clipping, temporary suture, and coagulation) versus control group (no occlusion of uterine arteries) to see the effect on intraoperative blood loss, postoperative hemoglobin, and impact on ovarian reserve. Participants will be randomly allocated into one of the following study arms: * ARM 1: Will undergo temporary clipping of both uterine arteries before laparoscopic myomectomy (LAP-M). * ARM 2: Will undergo temporary occlusion of both uterine arteries using the Shoe-lace suture technique before LAP-M. * ARM 3: Will undergo permanent occlusion of both uterine arteries using bipolar coagulation before LAP-M. * ARM 4 (Control group): Will undergo only LAP-M without occlusion of uterine arteries.
- Being tested
- Temporary clipping of uterine artery, Temporary occlusive suturing of uterine artery, Bipolar coagulation of uterine arteries, Laparoscopic myomectomy only
- Keywords
- Fibroids, Laparoscopic myomectomy, Blood loss, Uterine artery occlusion, Ovarian reserve
- Medical subject headings
- Leiomyoma, Blood Loss, Surgical, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Temporary clipping of uterine arteryProcedure or surgery
Both uterine arteries will be temporary clipped with a Titanium clip till the end of the myomectomy procedure
Temporary occlusive suturing of uterine arteryProcedure or surgery
A "Shoelace" suture will be applied to both uterine arteries and the sutures will be removed at the end of the myomectomy procdure
Bipolar coagulation of uterine arteriesProcedure or surgery
Permanent coagulation of both uterine arteries will be performed by Bipolar forceps before the start of the myomectomy procedure
Laparoscopic myomectomy onlyProcedure or surgery
No occlusion of uterine arteries will be performed. Only Laparoscopic myomectomy will be performed
| Study group | Role | What they receive |
|---|---|---|
| Temporary clipping of uterine arteries | Active comparator | Not described Receives: Procedure: Temporary clipping of uterine artery |
| Temporary occlusive suturing of uterine artery | Active comparator | Not described Receives: Procedure: Temporary occlusive suturing of uterine artery |
| Bipolar coagulation of uterine arteries | Active comparator | Not described Receives: Procedure: Bipolar coagulation of uterine arteries |
| No occlusion of uterine artery | Active comparator | Not described Receives: Procedure: Laparoscopic myomectomy only |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative blood loss
The amount of intraoperative blood loss measured at the end of the procedure by estimation of the total volume of fluid in the suction machine.
Measured: Within 40 minutes of end of the myomectomy procedure
Postoperative Hemoglobin shift
Postoperative hemoglobin level will be measured 24 hours after the procedure and the shift in hemoglobin from the preoperative level will be recorded
Measured: 24 hours after the procedure
Secondary outcomes (4)
Operative time of uterine artery occlusion
Duration from accessing the retroperitoneum to occlusion of both uterine arteries
Measured: Time lapsed from intraperitoneal laparoscopic entry till completion of bilateral uterine artery occlusion (in minutes)
Total operative time
The total time lapse from the peritoneal entry till the end of the myomectomy procedure
Measured: Time lapsed from intraperitoneal laparoscopic entry till completion of the myomectomy procedure and abdominal exit (in minutes)
Impact on ovarian reserve
Serum AMH will be measured 3 months postoperative and compared with the preoperative level
Measured: 3 months postoperatively
Intraoperative complications
The incidence of any intraoperative complications such as, blood transfusion, vascular injury, bowel injury, conversion to laparotomy, conversion to hysterectomy will be recorded in the four study arms.
Measured: 40 minutes, 90 minutes, 120 minutes Intraoperative and 24 hours, 48 hours, 7 days Postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start1 May 2025
- Primary completion31 Jan 2026
- Study completion25 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Uterine Fibroids (Leiomyoma)Studies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07352761
- Sponsor's protocol ID
- Alexandria University, OBGYN
- Status last verified
- Apr 2025
- First submitted
- 21 Dec 2025
- Last updated
- 14 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shoukry A, Aboali OA, Abdelquader MF, Gouda AMH. Comparing different techniques of uterine artery occlusion during laparoscopic myomectomy: a randomized controlled trial. BMC Womens Health. 2026 Aug 25;26(1):428. doi: 10.1186/s12905-026-04799-z.
PubMed 42649498
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Different Techniques of Bilateral Uterine Artery Occlusion During Laparoscopic Myomectomy: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07352761
- Acronym / sponsor ID
- Alexandria University, OBGYN
- Keywords
- Fibroids, Laparoscopic myomectomy, Blood loss, Uterine artery occlusion, Ovarian reserve
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 25 Feb 2026 (actual)
- First posted
- 20 Jan 2026 (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.
The current study is a multiple-arm, single blinded, and controlled randomized trial. It will be conducted in two gynecological endoscopy centers: • ElShatby University Hospital, a tertiary level hospital in Alexandria, Egypt. • Al-Madina Women Hospital, A specialized hospital of Obstetrics and Gynecology, Alexandria, Egypt. Patient selection: women with uterine leiomyomata and planning for laparoscopic myomectomy will be assessed for eligibility then will be enrolled in the trial according to the following inclusion and exclusion criteria, after providing a written informed consent of participation. Outcome variables of the study: The primary outcome is intraoperative blood loss and the change in postoperative hemoglobin. The secondary outcomes of this study are the operative time of performing uterine arteries occlusion and the postoperative ovarian reserve.
Detailed description
The goal of this clinical trial is to evaluate the safety and impact on ovarian reserve of different techniques of bilateral uterine artery occlusion in women in the reproductive age group scheduled for laparoscopic myomectomy. The main question[s] it aims to answer [is/are]:Do the different techniques for laparoscopic uterine artery occlusion prior to myomectomy decrease the intraoperative blood loss and the postoperative hemoglobin? The investigator intends to compare three different techniques for laparoscopic uterine artery occlusion (clipping, temporary suture, and coagulation) versus control group (no occlusion of uterine arteries) to see the effect on intraoperative blood loss, postoperative hemoglobin, and impact on ovarian reserve. Participants will be randomly allocated into one of the following study arms: * ARM 1: Will undergo temporary clipping of both uterine arteries before laparoscopic myomectomy (LAP-M). * ARM 2: Will undergo temporary occlusion of both uterine arteries using the Shoe-lace suture technique before LAP-M. * ARM 3: Will undergo permanent occlusion of both uterine arteries using bipolar coagulation before LAP-M. * ARM 4 (Control group): Will undergo only LAP-M without occlusion of uterine arteries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Temporary clipping of uterine arteries | Active comparator | Procedure: Temporary clipping of uterine artery |
| Temporary occlusive suturing of uterine artery | Active comparator | Procedure: Temporary occlusive suturing of uterine artery |
| Bipolar coagulation of uterine arteries | Active comparator | Procedure: Bipolar coagulation of uterine arteries |
| No occlusion of uterine artery | Active comparator | Procedure: Laparoscopic myomectomy only |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- women with uterine fibroids and complaining of either abnormal uterine bleeding, infertility, urinary or rectosigmoid pressure manifestations.
- Fibroid size from 3 - 10 cm in diameter and with
- a maximum number of 3 fibroids.
Key exclusion criteria (8 listed)
- contraindication to pneumoperitoneum and laparoscopy,
- patients with BMI > 30 kg/m2,
- history of midline abdominal incisions,
- women with history of prior ovarian surgery,
- women with history of hormonal treatment for the last 3 months before surgery,
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 clipping of uterine arteryBoth uterine arteries will be temporary clipped with a Titanium clip till the end of the myomectomy procedure | Procedure or surgery | Temporary clipping of uterine arteries |
| Temporary occlusive suturing of uterine arteryA "Shoelace" suture will be applied to both uterine arteries and the sutures will be removed at the end of the myomectomy procdure | Procedure or surgery | Temporary occlusive suturing of uterine artery |
| Bipolar coagulation of uterine arteriesPermanent coagulation of both uterine arteries will be performed by Bipolar forceps before the start of the myomectomy procedure | Procedure or surgery | Bipolar coagulation of uterine arteries |
| Laparoscopic myomectomy onlyNo occlusion of uterine arteries will be performed. Only Laparoscopic myomectomy will be performed | Procedure or surgery | No occlusion of uterine artery |
Primary outcome
Intraoperative blood loss
Time frame: Within 40 minutes of end of the myomectomy procedure
The amount of intraoperative blood loss measured at the end of the procedure by estimation of the total volume of fluid in the suction machine.
Postoperative Hemoglobin shift
Time frame: 24 hours after the procedure
Postoperative hemoglobin level will be measured 24 hours after the procedure and the shift in hemoglobin from the preoperative level will be recorded
4 secondary outcomes
Operative time of uterine artery occlusion
Time frame: Time lapsed from intraperitoneal laparoscopic entry till completion of bilateral uterine artery occlusion (in minutes)
Total operative time
Time frame: Time lapsed from intraperitoneal laparoscopic entry till completion of the myomectomy procedure and abdominal exit (in minutes)
Impact on ovarian reserve
Time frame: 3 months postoperatively
Intraoperative complications
Time frame: 40 minutes, 90 minutes, 120 minutes Intraoperative and 24 hours, 48 hours, 7 days Postoperatively
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 14 Jul 2026.
- Derived from this study: PubMed 42649498Shoukry A, Aboali OA, Abdelquader MF, Gouda AMH. Comparing different techniques of uterine artery occlusion during laparoscopic myomectomy: a randomized controlled trial. BMC Womens Health. 2026 Aug 25;26(1):428. doi: 10.1186/s12905-026-04799-z.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Temporary clipping of uterine artery, Temporary occlusive suturing of uterine artery and Bipolar coagulation of uterine arteries in people with Uterine Fibroids (Leiomyoma) and Myomectomy, run by Alexandria 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 3 inclusion and 8 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 14 Jul 2026. 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?
Intraoperative blood loss (time frame: Within 40 minutes of end of the myomectomy procedure). The study lists 2 primary outcomes in all. 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 NCT07352761, which also lists 1 linked publication.
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 Jul 2026.