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Recruiting NCT07119060

NCT07119060 Ablative Technique For Ovarian Preservation In Endometrioma

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Clinical Trial Summary
NCT ID NCT07119060
Status Recruiting
Phase
Sponsor Clinique Tivoli Ducos
Condition Endometrioma
Study Type INTERVENTIONAL
Enrollment 332 participants
Start Date 2025-09-18
Primary Completion 2034-07

Trial Parameters

Condition Endometrioma
Sponsor Clinique Tivoli Ducos
Study Type INTERVENTIONAL
Phase N/A
Enrollment 332
Sex FEMALE
Min Age 18 Years
Max Age 43 Years
Start Date 2025-09-18
Completion 2034-07
Interventions
Cystectomyplasma vaporizationSclerotherapy

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Brief Summary

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

Eligibility Criteria

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

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