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Changes in Serum antimüllerian Hormone Levels in Patients 3 and 12 Months After Endometrioma Sclerotherapy

Changes in Serum antimüllerian Hormone Levels in Patients 3 and 12 Months After Endometrioma Sclerotherapy

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04461899
Acronym
ENDOPAL AMH
Enrollment
53
Registered
2020-07-08
Start date
2020-07-09
Completion date
2023-04-14
Last updated
2023-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometriosis Ovary

Keywords

endometrioma, sclerotherapy, ovarian reserve, antimüllerian hormone

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.

Interventions

BIOLOGICALBlood test

additional blood test will be done 3 and 12 months after endometrioma sclerotherapy.

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 42 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
AMH level3 months (+/-15 days) after endometrioma sclerotherapy

Secondary

MeasureTime frameDescription
AMH level12 months (+/-15 days) after endometrioma sclerotherapy
Endometrioma recurrence3 months (+/-15 days) after endometrioma sclerotherapyNew endometrioma (≥ 2 cm) unilateral or bilateral, single or multiple

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026