NCT02563392Completed
Does Preventive Uterine Artery Occlusion During Laparoscopic Myomectomy Impact on Ovarian Reserve Markers?
Does Preventive Uterine Artery Occlusion During Laparoscopic Myomectomy Impact on Ovarian Reserve Markers? A Randomized Control Trial
Source: ClinicalTrials.gov · Last updated 13 Aug 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 58 (actual)
- First submitted
- 9 Jul 2015
- Start date
- Apr 2015
- Primary completion date
- May 2024
- Lead sponsor
- University Hospital, Geneva
- NCT number
- NCT02563392
What you commit to
- Study type: Interventional
- Participants enrolled: 58
- From Apr 2015 to the primary completion date, May 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- pregnant patients.
- who underwent radiological uterine artery embolization.
- who have an undetectable AMH levels (\<3 pmol / l).
- over 45 years
Who the study is looking for
- 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
Age in the registry: 18 years to 45 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hôpitaux Universitaires de Genève, Service de gynécologie Coordinator of this site? Confirm its status | Geneva | Switzerland | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.