Ablative Technique For Ovarian Preservation In Endometrioma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cystectomy, plasma vaporization, Sclerotherapy.
- Who it may be relevant to
- Registry conditions: Endometrioma, Fertility. Basic parameters: 18 years — 43 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Monocentric, Controlled, Randomized Trial: Comparison of Pregnancy Rates in Women With One or More Endometriomas, Treated by Cystectomy, Plasma Vaporization, or Sclerotherapy
Overview
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
Interventions
- Procedure Cystectomy
Surgical removal of the endometrioma by gently pulling the cyst wall away from the ovarian tissue (divergent traction technique) - Procedure plasma vaporization
It consists of destroying the cyst wall (vaporization) using plasma energy - Procedure Sclerotherapy
Ethanol sclerotherapy destroys the endometriotic tissue lining the inner wall of the cyst through prolonged contact with 96% alcohol
Primary outcome measures
- To compare pregnancy rates observed up to 24 months after surgery for endometriosis with endometrioma treatment [Time frame: From enrollment to 24 months after the surgery]
Secondary outcome measures (7)
- To compare birth rates pregnancies [Time frame: From enrollment to 24 months after the surgery]
- To compare spontaneous pregnancy rates [Time frame: From enrollment to 24 months after the surgery]
- To compare pregnancies achieved through assisted reproductive technology (ART) [Time frame: From enrollment to 24 months after the surgery]
- To compare pregnancies progressing beyond 12 weeks of amenorrhea [Time frame: From enrollment to 24 months after the surgery]
- To compare the recurrence rate of endometriomas, defined as the appearance of an endometrioma larger than 2 cm on the same ovary. [Time frame: From enrollment to 24 months after the surgery]
- To compare postoperative complication rates [Time frame: During 3 months after the surgery]
- To compare pain scores using the Biberoglu and Behrman scale (Biberoglu and Behrman >4) [Time frame: From enrollment to 24 months after the surgery]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
France · 1 center
- IFEMEndo - Clinique Tivoli — Bordeaux
Publications
- Crestani A, Merlot B, Chanavaz Lacheray I, Dennis T, Goualard PH, Roman H. ATOPE study protocol: a randomised controlled trial comparing cystectomy and plasma vapourisation in endometriomas under 6 cm, with an observational arm for sclerotherapy in larger cysts. BMJ Open. 2026 Apr 28;16(4):e112291. doi: 10.1136/bmjopen-2025-112291. PMID 42049313
Identifiers
NCT: NCT07119060 · CliTiv-01-2025 · 2024-A01400-47