Ablative Technique For Ovarian Preservation In Endometrioma (ATOPE)

Clinique Tivoli Ducos

Status: Not yet enrolling

Conditions: Fertility; Endometrioma

Treatments: Procedure: plasma vaporization; Procedure: Sclerotherapy; Procedure: Cystectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT07119060

2024-A01400-47 (Other Identifier)

CliTiv-01-2025

Details and patient eligibility

About

The goal of this clinical trial is to compare pregnancy rates after different surgical treatments for endometriomas in adult women who have one or more ovarian cysts (endometriomas) larger than 2 cm requiring surgery. The main questions it aims to answer are:

How many women become pregnant within 24 months after surgery ? What are the birth rates and different types of pregnancies (natural, with fertility treatments, and those continuing beyond 12 weeks)? How often do the endometriomas come back after surgery? What surgery-related complications occur? How do pain levels change after treatment?

Researchers will compare different surgical treatment groups to see if one approach results in better pregnancy outcomes and fewer complications.

Participants will:

Be randomly assigned to different surgical treatment groups Undergo surgery for their endometriomas and endometriosis Attend follow-up visits at 3 months and 24 months after the procedure Have their pregnancy outcomes, pain levels, and potential complications monitored throughout the study period

Enrollment: 332 estimated patients

Sex: Female

Ages: 18 to 43 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patient aged between 18 and 43 years (inclusive)
• Patient diagnosed with endometriosis (by histology or imaging) and symptomatic, requiring surgery (pelvic pain and/or infertility and/or risk to an organ)
• Pelvic MRI or ultrasound performed within the last year showing at least one endometrioma larger than 20 mm in diameter
• Patient with an intention to conceive (probable or certain) after surgery
• Patient informed and having signed the consent form
• Patient covered by a social security scheme

Exclusion criteria

• Intraoperative finding that the cyst is not an endometrioma
• Patient under guardianship, conservatorship, or incapable of giving consent
• Patient without sufficient understanding of the French language
• Patient under judicial protection measures
• Patient who is pregnant or breastfeeding

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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332 participants in 3 patient groups

cystectomy

Experimental group

Description:

Surgical removal of the endometrioma by gently pulling the cyst wall away from the ovarian tissue (divergent traction technique)

Treatment:

Procedure: Cystectomy

vaporization with plasma

Active Comparator group

Description:

It consists of destroying the cyst wall (vaporization) using plasma energy.

Treatment:

Procedure: plasma vaporization

sclerotherapy

Other group

Description:

Ethanol sclerotherapy destroys the endometriotic tissue lining the inner wall of the cyst through prolonged contact with 96% ethanol.

Treatment:

Procedure: Sclerotherapy