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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Cystectomy
Procedure/SurgerySurgical removal of the endometrioma by gently pulling the cyst wall away from the ovarian tissue (divergent traction technique)
plasma vaporization
Procedure/SurgeryIt consists of destroying the cyst wall (vaporization) using plasma energy
Sclerotherapy
Procedure/SurgeryEthanol sclerotherapy destroys the endometriotic tissue lining the inner wall of the cyst through prolonged contact with 96% alcohol
Treatment groups
332 Participants
are divided into 3 treatment groupsGroup A: cystectomyExperimental treatment 1 intervention
Group B: vaporization with plasmaActive comparator 1 intervention
Group C: sclerotherapyOther 1 intervention
Trial outcomes
Primary outcomes
1
To compare pregnancy rates observed up to 24 months after surgery for endometriosis with endometrioma treatment
A Pregnancy is considered if the CGH is \>1000 UI/L or a intra uterine pregnancy after 5 weeks of amenorrhea
Time frame
From enrollment to 24 months after the surgerySecondary outcomes
1
To compare birth rates pregnancies
Time frame
From enrollment to 24 months after the surgery2
To compare spontaneous pregnancy rates
Time frame
From enrollment to 24 months after the surgery3
To compare pregnancies achieved through assisted reproductive technology (ART)
Time frame
From enrollment to 24 months after the surgery4
To compare pregnancies progressing beyond 12 weeks of amenorrhea
Time frame
From enrollment to 24 months after the surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov