Uterine MyomaORAMNCT02563392
Does Preventive Uterine Artery Occlusion During Laparoscopic Myomectomy Impact on Ovarian Reserve Markers?
A study testing uterine myomectomy with preventive uterine arteries occlusion and laparoscopic uterine myomectomy without preventive uterine arteries occlusion in people with Uterine Myoma, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
Hysterectomy is an effective treatment used as a first-line approach for uterine myomas. Several others alternatives to hysterectomy have been developed in recent years for women wishing to retain their uterus: myomectomy, radiological embolization, focused ultrasound. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Uterine Myoma
- What is being tested?
- uterine myomectomy with preventive uterine arteries occlusion and laparoscopic uterine myomectomy without preventive uterine arteries occlusion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2015to May 2024
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- over 18 years
- signed the surgery consent form
- capable of discernment understanding and accepting the risks and benefits of the operation
- symptomatic : menorrhagia, breakthrough bleeding and / or pelvic pain and / or infertility and / or repeated spontaneous abortions.
- uterine myoma or more, including at least one type of myoma FIGO 2-6 (International Federation of Gynecology and Obstetrics) objectified by ultrasound and / or pelvic MRI
- laparoscopic approach is technically feasible (as recommended by the National College of Obstetrics and Gynecology French published in 2011): myoma single lower or equal to 9 cm or sum of the size of myomas in centimeters or less equal to 13 and number of myomas inferior to four.
- Female patients of childbearing age younger than 45 years and having a plasma AMH (anti-Mullerian hormone) than 3 pmol / l.
- Patients who accept a postoperative follow-up of 2 years
Who cannot join
- pregnant patients.
- who underwent radiological uterine artery embolization.
- who have an undetectable AMH levels (<3 pmol / l).
- over 45 years
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Hôpitaux Universitaires de Genève, Service de gynécologie
Geneva, 1206
About this study
Official title: Does Preventive Uterine Artery Occlusion During Laparoscopic Myomectomy Impact on Ovarian Reserve Markers? A Randomized Control Trial
Hysterectomy is an effective treatment used as a first-line approach for uterine myomas. Several others alternatives to hysterectomy have been developed in recent years for women wishing to retain their uterus: myomectomy, radiological embolization, focused ultrasound.
Myomectomy, particularly through minimally invasive surgery, is currently considered the conservative treatment of choice for patients wishing to preserve their fertility. However, three important issues should be considered: the risk of intra- and postoperative bleeding, the risk for recurring myomas, and the preservation of subsequent fertility.
Preventive uterine artery occlusion can be combined with laparoscopic myomectomy in order to avoid bleeding and improve uterine suture. Another expected long-term benefit is the improvement of treatment efficacy, leading to less symptoms and myomas recurrence. However, the effect of uterine arteries occlusion on the ovarian reserve of women of childbearing age has not yet been studied, which limits its clinical application.
Read the detailed description
Objectives:
- To assess the effect of preventive uterine artery occlusion during laparoscopic myomectomy on ovarian reserve parameters;
- To evaluate the effect of preventive uterine artery occlusion during laparoscopic myomectomy on intra- and postoperative blood loss, operative time, clinical symptoms improvement, long-term recurrence of myomas and fertility.
Materials and methods:
Design: This is a prospective randomized single blind trial, including 60 women undergoing a laparoscopic myomectomy for symptomatic uterine myomas. Patients are randomized into two groups: a control group "myomectomy alone" and an experimental group "myomectomy with preventive uterine arteries occlusion".
Setting: The duration of the study will normally be 5 years and will take place at the University Hospitals of Geneva. The study will include about 20 women per year and follow-up will last 2 years. Inclusion criteria are: women of childbearing age, wishing to retain their uterus, having symptomatic uterine myomas and who are eligible for a laparoscopic myomectomy.
The parameters that will be intraoperatively evaluated are the operation time, blood loss and the complications of the surgical technique. Postoperative complications, improving clinical symptoms, myomas recurrence and fertility are discussed at short and long term follow-up.
The ovarian reserve will be evaluated pre- and postoperatively for each patient. It will be determined by plasmatic AMH (anti-Mullerian Hormone) and ultrasound antral follicle count. Women with undetectable preoperative plasmatic AMH will be excluded from the study. Plasmatic AMH and antral follicle count will be measured at 1, 3, 6, 12 and 24 months during the postoperative follow-up.
Limitations:
The sample size is calculated in order to demonstrate a significant difference in plasmatic AMH before and after myomectomy. Small differences are not highlighted in this study, but they probably would not have any impact in clinical practice.
Impact of the study:
The results of this study could have a real impact on daily surgical practice. In case of persistent alteration of ovarian reserve in the experimental group compared to the control group, preventive uterine arteries occlusion during a laparoscopic myomectomy should only be indicated in patients who do not wish pregnancy. If there is no significant impact on ovarian reserve and a beneficial effect on reducing intraoperative blood loss and long-term improvement of symptoms, it should be systematically proposed in all patients undergoing a laparoscopic myomectomy.
- Conditions
- Uterine Myoma
- Being tested
- uterine myomectomy with preventive uterine arteries occlusion, laparoscopic uterine myomectomy without preventive uterine arteries occlusion
- Medical subject headings
- Myofibroma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
uterine myomectomy with preventive uterine arteries occlusionProcedure or surgery
laparoscopic uterine myomectomy with preventive uterine arteries occlusion
laparoscopic uterine myomectomy without preventive uterine arteries occlusionProcedure or surgery
laparoscopic uterine myomectomy
| Study group | Role | What they receive |
|---|---|---|
| Uterine arteries occlusion | Experimental | Laparoscopic myomectomy with preventive uterine arteries occlusion Receives: Procedure: uterine myomectomy with preventive uterine arteries occlusion |
| No uterine arteries occlusion | Active comparator | Laparoscopic myomectomy without preventive uterine arteries occlusion Receives: Procedure: laparoscopic uterine myomectomy without preventive uterine arteries occlusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of ovarian reserve markers after myomectomy
It will be determined by plasmatic AMH and ultrasound antral follicle count
Measured: Evaluation of the ovarian reserve at several times: on preoperative, 1, 3, 6, 12 and 24 months postoperative
Secondary outcomes (7)
Intra-and post-operative blood loss
Blood loss will be estimated during the operation, and will be followed for the duration of hospital stay, an expected average of 3 days. furthermore, we will dose the hemoglobin before and after the intervention.
Measured: peroperative
operative time
Time needed to realise the intervention from the incision to the cutaneous stitches
Measured: peroperative
peroperative complications
it will be noticed the conversion in laparotomy, the blood transfusion, the organic and vessels lesions
Measured: peroperative
Clinical symptoms improvement: hypermenorrhea
Evaluation of quantity of blood during menstruation with the PBAC scale (Pictorial Blood Assessment Chart) before and after the intervention
Measured: 1, 3, 6, 12 and 24 months postoperative
Clinical symptoms improvement: dysmenorrhea
Evaluation of improvement of dysmenorrhea by asking patients the pain they have from 0 to 10 and their consumption of pain killers (NSAIDs and paracetamol) during menstruation.
Measured: 1, 3, 6, 12 and 24 months postoperative
Clinical symptoms improvement: occuring of pregnancy
Evaluation of the occurence of pregnancy by asking women the number of pregnancy, of miscarriage, of abortion, of term pregnancy since the intervention
Measured: 12 and 24 months postoperative
long-term recurrence of myomas
An US will be made at 1, 3, 6, 12 and 24 months to estimate the recidive of myoma. It will be considered a recidive when the myoma will be bigger than 20 mm
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2015 (estimated)
- Study startApr 2015
- Primary completionMay 2024
- Study completionMay 2024
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 MyomaStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe 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
- Participant
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isabelle Streuli, University Hospital, Geneva
- Investigators
- Patrick Petignat, Pr, Study director, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02563392
- Sponsor's protocol ID
- 14-129
- Acronym
- ORAM
- Status last verified
- Aug 2024
- First submitted
- 9 Jul 2015
- Last updated
- 13 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Streuli I, Ramyead L, Silvestrini N, Petignat P, Dubuisson J. Impact of definitive uterine artery occlusion on ovarian reserve markers in laparoscopic myomectomy: a randomized controlled trial with 2-year follow-up. Hum Reprod. 2025 Jul 1;40(7):1305-1314. doi: 10.1093/humrep/deaf070.
PubMed 40420404
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Preventive Uterine Artery Occlusion During Laparoscopic Myomectomy Impact on Ovarian Reserve Markers? A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02563392
- Acronym / sponsor ID
- ORAM / 14-129
- Conditions
- Uterine Myoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- May 2024 (actual)
- Study completion
- May 2024 (actual)
- First posted
- 30 Sep 2015 (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.
Hysterectomy is an effective treatment used as a first-line approach for uterine myomas. Several others alternatives to hysterectomy have been developed in recent years for women wishing to retain their uterus: myomectomy, radiological embolization, focused ultrasound.
Myomectomy, particularly through minimally invasive surgery, is currently considered the conservative treatment of choice for patients wishing to preserve their fertility. However, three important issues should be considered: the risk of intra- and postoperative bleeding, the risk for recurring myomas, and the preservation of subsequent fertility.
Preventive uterine artery occlusion can be combined with laparoscopic myomectomy in order to avoid bleeding and improve uterine suture. Another expected long-term benefit is the improvement of treatment efficacy, leading to less symptoms and myomas recurrence. However, the effect of uterine arteries occlusion on the ovarian reserve of women of childbearing age has not yet been studied, which limits its clinical application.
Detailed description
Objectives:
- To assess the effect of preventive uterine artery occlusion during laparoscopic myomectomy on ovarian reserve parameters;
- To evaluate the effect of preventive uterine artery occlusion during laparoscopic myomectomy on intra- and postoperative blood loss, operative time, clinical symptoms improvement, long-term recurrence of myomas and fertility.
Materials and methods:
Design: This is a prospective randomized single blind trial, including 60 women undergoing a laparoscopic myomectomy for symptomatic uterine myomas. Patients are randomized into two groups: a control group "myomectomy alone" and an experimental group "myomectomy with preventive uterine arteries occlusion".
Setting: The duration of the study will normally be 5 years and will take place at the University Hospitals of Geneva. The study will include about 20 women per year and follow-up will last 2 years. Inclusion criteria are: women of childbearing age, wishing to retain their uterus, having symptomatic uterine myomas and who are eligible for a laparoscopic myomectomy.
The parameters that will be intraoperatively evaluated are the operation time, blood loss and the complications of the surgical technique. Postoperative complications, improving clinical symptoms, myomas recurrence and fertility are discussed at short and long term follow-up.
The ovarian reserve will be evaluated pre- and postoperatively for each patient. It will be determined by plasmatic AMH (anti-Mullerian Hormone) and ultrasound antral follicle count. Women with undetectable preoperative plasmatic AMH will be excluded from the study. Plasmatic AMH and antral follicle count will be measured at 1, 3, 6, 12 and 24 months during the postoperative follow-up.
Limitations:
The sample size is calculated in order to demonstrate a significant difference in plasmatic AMH before and after myomectomy. Small differences are not highlighted in this study, but they probably would not have any impact in clinical practice.
Impact of the study:
The results of this study could have a real impact on daily surgical practice. In case of persistent alteration of ovarian reserve in the experimental group compared to the control group, preventive uterine arteries occlusion during a laparoscopic myomectomy should only be indicated in patients who do not wish pregnancy. If there is no significant impact on ovarian reserve and a beneficial effect on reducing intraoperative blood loss and long-term improvement of symptoms, it should be systematically proposed in all patients undergoing a laparoscopic myomectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Uterine arteries occlusion | Experimental | Procedure: uterine myomectomy with preventive uterine arteries occlusionLaparoscopic myomectomy with preventive uterine arteries occlusion |
| No uterine arteries occlusion | Active comparator | Procedure: laparoscopic uterine myomectomy without preventive uterine arteries occlusionLaparoscopic myomectomy without preventive uterine arteries occlusion |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- over 18 years
- signed the surgery consent form
- capable of discernment understanding and accepting the risks and benefits of the operation
- symptomatic : menorrhagia, breakthrough bleeding and / or pelvic pain and / or infertility and / or repeated spontaneous abortions.
- uterine myoma or more, including at least one type of myoma FIGO 2-6 (International Federation of Gynecology and Obstetrics) objectified by ultrasound and / or pelvic MRI
Key exclusion criteria (4 listed)
- pregnant patients.
- who underwent radiological uterine artery embolization.
- who have an undetectable AMH levels (<3 pmol / l).
- over 45 years
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 |
|---|---|---|
| uterine myomectomy with preventive uterine arteries occlusionlaparoscopic uterine myomectomy with preventive uterine arteries occlusion | Procedure or surgery | Uterine arteries occlusion |
| laparoscopic uterine myomectomy without preventive uterine arteries occlusionlaparoscopic uterine myomectomy | Procedure or surgery | No uterine arteries occlusion |
Primary outcome
Evolution of ovarian reserve markers after myomectomy
Time frame: Evaluation of the ovarian reserve at several times: on preoperative, 1, 3, 6, 12 and 24 months postoperative
It will be determined by plasmatic AMH and ultrasound antral follicle count
7 secondary outcomes
Intra-and post-operative blood loss
Time frame: peroperative
operative time
Time frame: peroperative
peroperative complications
Time frame: peroperative
Clinical symptoms improvement: hypermenorrhea
Time frame: 1, 3, 6, 12 and 24 months postoperative
Clinical symptoms improvement: dysmenorrhea
Time frame: 1, 3, 6, 12 and 24 months postoperative
Clinical symptoms improvement: occuring of pregnancy
Time frame: 12 and 24 months postoperative
long-term recurrence of myomas
Time frame: 2 years
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 13 Aug 2024.
- Derived from this study: PubMed 40420404Streuli I, Ramyead L, Silvestrini N, Petignat P, Dubuisson J. Impact of definitive uterine artery occlusion on ovarian reserve markers in laparoscopic myomectomy: a randomized controlled trial with 2-year follow-up. Hum Reprod. 2025 Jul 1;40(7):1305-1314. doi: 10.1093/humrep/deaf070.
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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.
Patrick Petignat, Pr study director
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing uterine myomectomy with preventive uterine arteries occlusion and laparoscopic uterine myomectomy without preventive uterine arteries occlusion in people with Uterine Myoma, run by University Hospital, Geneva at 1 site in Switzerland.
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 8 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: finished, as of the sponsor's last update on 13 Aug 2024. 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 Switzerland. 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?
Evolution of ovarian reserve markers after myomectomy (time frame: Evaluation of the ovarian reserve at several times: on preoperative, 1, 3, 6, 12 and 24 months postoperative). 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 NCT02563392, 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 13 Aug 2024.