Ablative Technique For Ovarian Preservation In Endometrioma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-43
SponsorClinique Tivoli Ducos
About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Cystectomy
- plasma vaporization
- Sclerotherapy
Treatment groups
332 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov