Does Preventive Uterine Artery Occlusion During Laparoscopic Myomectomy Impact on Ovarian Reserve… (NCT02563392) | Clinical Trial Compass
CompletedNot Applicable
Does Preventive Uterine Artery Occlusion During Laparoscopic Myomectomy Impact on Ovarian Reserve Markers?
Switzerland58 participantsStarted 2015-04
Plain-language 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.
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.
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* pregnant patients.
* who underwent radiological uterine artery embolization.
* who have an undetectable AMH levels (\<3 pmol / l).
* over 45 years
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evolution of ovarian reserve markers after myomectomy
Timeframe: Evaluation of the ovarian reserve at several times: on preoperative, 1, 3, 6, 12 and 24 months postoperative