Clinical trial NCT04461899: Changes in Serum antimüllerian Hormone Levels in Patients 3 and 12 Months After Endometrioma Sclerotherapy
Official title: Changes in Serum antimüllerian Hormone Levels in Patients 3 and 12 Months After Endometrioma Sclerotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometriosis Ovary
Keywords: endometrioma
sclerotherapy
ovarian reserve
antimüllerian hormone
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-07-08
Enrollment: 53
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 42
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: AMH level
timeFrame: 3 months (+/-15 days) after endometrioma sclerotherapy
Secondary outcomes:
measure: AMH level
timeFrame: 12 months (+/-15 days) after endometrioma sclerotherapy
measure: AMH level
timeFrame: 12 months after endometrioma sclerotherapy
measure: Endometrioma recurrence
timeFrame: 3 months (+/-15 days) after endometrioma sclerotherapy
measure: Endometrioma recurrence
timeFrame: 12 months (+/-15 days) after endometrioma sclerotherapy
Other outcomes:
Locations:
city: Bron
country: France
facility: Hopital Femme Mère Enfant
city: Lyon
country: France
facility: Hopital de la Croix Rousse
city: Pierre-Bénite
country: France
facility: Hopital Lyon Sud
Study officials:
affiliation: Hospices Civils de Lyon
name: Gil DUBERNARD, Pr
role: PRINCIPAL_INVESTIGATOR
References: