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

Not Applicable

Completed

• Conditions: Endometriosis Ovary
• Interventions: Biological: Blood test

• Registration Number: NCT04461899
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-29
• Study First Submitted QC: 2020-07-07
• Study First Posted: 2020-07-08
• Study Start: 2020-07-09
• Primary Completion: 2023-04-14
• Study Completion: 2023-04-14
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-22
• Last Update Posted: 2023-09-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 53

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
sclerotherapy	Blood test	a sclerotherapy will be done in patients

Primary Outcome Measures

Name	Time	Method
AMH level	3 months (+/-15 days) after endometrioma sclerotherapy

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Hopital Lyon Sud; 🇫🇷 Pierre-Bénite, France

Hopital Femme Mère Enfant; 🇫🇷 Bron, France

Hopital de la Croix Rousse; 🇫🇷 Lyon, France