Changes in Serum antimüllerian Hormone Levels in Patients 3 and 12 Months After Endometrioma Sclerotherapy (ENDOPAL AMH)

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.

Study Overview

• Status: Completed
• Conditions: Endometriosis Ovary
• Intervention / Treatment: Biological: Blood test

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Bron, France
    • Hôpital Femme Mère Enfant
  • Lyon, France, 69004
    • Hôpital de la Croix Rousse
  • Pierre-Bénite, France, 69495
    • Hôpital Lyon Sud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 38 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: sclerotherapy; a sclerotherapy will be done in patients	Biological: Blood test; additional blood test will be done 3 and 12 months after endometrioma sclerotherapy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
AMH level	3 months (+/-15 days) after endometrioma sclerotherapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AMH level		12 months (+/-15 days) after endometrioma sclerotherapy
AMH level	AMH level 3 and 12 months after endometrioma sclerotherapy	12 months after endometrioma sclerotherapy
Endometrioma recurrence	New endometrioma (≥ 2 cm) unilateral or bilateral, single or multiple	3 months (+/-15 days) after endometrioma sclerotherapy
Endometrioma recurrence	New endometrioma (≥ 2 cm) unilateral or bilateral, single or multiple	12 months (+/-15 days) after endometrioma sclerotherapy

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Gil DUBERNARD, Pr, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2020
• Primary Completion (Actual): April 14, 2023
• Study Completion (Actual): April 14, 2023

Study Registration Dates

• First Submitted: June 29, 2020
• First Submitted That Met QC Criteria: July 7, 2020
• First Posted (Actual): July 8, 2020

Study Record Updates

• Last Update Posted (Actual): September 25, 2023
• Last Update Submitted That Met QC Criteria: September 22, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: sclerotherapy; ovarian reserve; endometrioma; antimüllerian hormone
• Additional Relevant MeSH Terms: Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Endometriosis
• Other Study ID Numbers: 69HCL20_0002; 2020-A00118-31 (Other Identifier: ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No