Ablative Technique For Ovarian Preservation In Endometrioma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

332 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2035-01-31

Brief Summary

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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

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Detailed Description

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Conditions

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Endometrioma Fertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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cystectomy

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

Group Type EXPERIMENTAL

Cystectomy

Intervention Type PROCEDURE

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

vaporization with plasma

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

Group Type ACTIVE_COMPARATOR

plasma vaporization

Intervention Type PROCEDURE

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

sclerotherapy

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

Group Type OTHER

Sclerotherapy

Intervention Type PROCEDURE

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

Interventions

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Cystectomy

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

Intervention Type PROCEDURE

plasma vaporization

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

Intervention Type PROCEDURE

Sclerotherapy

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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

43 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No