Changes in Serum antimüllerian Hormone Levels in Patients 3 and 12 Months After Endometrioma Scle… (NCT04461899) | Clinical Trial Compass
CompletedNot Applicable
Changes in Serum antimüllerian Hormone Levels in Patients 3 and 12 Months After Endometrioma Sclerotherapy
France53 participantsStarted 2020-07-09
Plain-language summary
Endometriosis affects 6-10% of women in childbearing age. It is a heterogeneous disease with three different forms: superficial endometriosis (peritoneal), ovarian endometrioma and deep pelvic endometriosis (subperitoneal).
Surgical management of endometriomas is justified in cases of significant clinical symptoms (like pain), especially in cases of resistance to medical treatment. Currently, laparoscopic cystectomy surgery is the recommended technique to treat ovarian endometrioma. However, it is now well demonstrated that this surgery significantly reduces the ovarian reserve.
Ethanol sclerotherapy is an alternative technique used to treat ovarian endometriomas. Several studies demonstrated the effectiveness and safety of this treatment, particularly in terms of preserving fertility. Regarding these reassuring data, many clinicians changed their practices and propose this technique as a first-line surgery.
Ovarian reserve comprises two elements: size of the primordial follicle stock and quality of the ovocytes. Antimüllerian hormone (AMH) has been shown to be the best marker of fertility.
The aim of this study is to observe changes in AMH levels after endometrioma sclerotherapy. This study is conducted in the Hospices Civils de Lyon, in 3 different sites.
Who can participate
Age range
18 Years – 42 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:
* Patient in childbearing age from 18 to 42 years.
* Patient with uni- or bilateral endometrioma(s) without clinical and ultrasound criteria for ovarian carcinoma.
* A sclerotherapy is programmed.
* Patient affiliated to a social security scheme.
* Patient who gave consent for this research.
Exclusion Criteria:
* doubt about the endometriotic origin of the cyst
* suspect malignant ovarian disease.
* Pregnant or breastfeeding patient.
* Patient participating in other research with an exclusion period still in progress at the time of inclusion or those included in interventional research that interferes with the study protocol.
* Patient deprived of liberty by judicial or administrative decision.
* Patient (≥ 18 years old) under legal protection or unable to give consent.
* Patient does not speak French.
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
AMH level
Timeframe: 3 months (+/-15 days) after endometrioma sclerotherapy