Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:28 PM
Ignite Modification Date:
2025-12-24 @ 3:28 PM
NCT ID:
NCT02563392
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT02563392
Study Brief:
Protocol Section:
NCT02563392