EndometriomaATOPENCT07119060
Ablative Technique For Ovarian Preservation In Endometrioma
A study testing Cystectomy, plasma vaporization and Sclerotherapy in people with Endometrioma and Fertility, run by Clinique Tivoli Ducos at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 43 years, women only
- Conditions the study is for
- Endometrioma, Fertility
- What is being tested?
- Cystectomy, plasma vaporization and Sclerotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 332 participants
- Where
- 1 siteFrance
- Study dates
- 18 Sep 2025to Jan 2035
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 43 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
IFEMEndo - Clinique Tivoli
Bordeaux, 33000
Clotilde HUET, +33 7 85 30 63 45, recherche@ifemendo.fr
Kristina ANANIAN, +33 6 50 13 92 54, arc@ifemendo.fr
About this study
Official title: Monocentric, Controlled, Randomized Trial: Comparison of Pregnancy Rates in Women With One or More Endometriomas, Treated by Cystectomy, Plasma Vaporization, or Sclerotherapy
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?
Read more
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
- Conditions
- Endometrioma, Fertility
- Being tested
- Cystectomy, plasma vaporization, Sclerotherapy
- Keywords
- surgery, endometrioma, endometriosis, kystectomy, sclerotherapy, plasma vaporization, fertility
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CystectomyProcedure or surgery
Surgical removal of the endometrioma by gently pulling the cyst wall away from the ovarian tissue (divergent traction technique)
plasma vaporizationProcedure or surgery
It consists of destroying the cyst wall (vaporization) using plasma energy
SclerotherapyProcedure or surgery
Ethanol sclerotherapy destroys the endometriotic tissue lining the inner wall of the cyst through prolonged contact with 96% alcohol
| Study group | Role | What they receive |
|---|---|---|
| cystectomy | Experimental | Surgical removal of the endometrioma by gently pulling the cyst wall away from the ovarian tissue (divergent traction technique) Receives: Procedure: Cystectomy |
| vaporization with plasma | Active comparator | It consists of destroying the cyst wall (vaporization) using plasma energy. Receives: Procedure: plasma vaporization |
| sclerotherapy | Other | Ethanol sclerotherapy destroys the endometriotic tissue lining the inner wall of the cyst through prolonged contact with 96% ethanol. Receives: Procedure: Sclerotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: From enrollment to 24 months after the surgery
Secondary outcomes (7)
To compare birth rates pregnancies
Measured: From enrollment to 24 months after the surgery
To compare spontaneous pregnancy rates
Measured: From enrollment to 24 months after the surgery
To compare pregnancies achieved through assisted reproductive technology (ART)
Measured: From enrollment to 24 months after the surgery
To compare pregnancies progressing beyond 12 weeks of amenorrhea
Measured: 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.
Measured: From enrollment to 24 months after the surgery
To compare postoperative complication rates
Measured: During 3 months after the surgery
To compare pain scores using the Biberoglu and Behrman scale (Biberoglu and Behrman >4)
Pelvic pain will be assessed using the Biberoglu and Behrman scale, which evaluates pain in three domains: dysmenorrhea, dyspareunia, and pelvic pain on palpation. Each domain is scored from 0 (no pain) to 3 (severe pain), with a total score ranging from 0 to 9.
Higher scores indicate more severe pain (i.e., a worse outcome). A score greater than 4 is considered clinically significant.
Measured: From enrollment to 24 months after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2025
- Study start18 Sep 2025
- Primary completionJul 2034 (estimated)
- Study completionJan 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for EndometriomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 332 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Clinique Tivoli Ducos
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Horace ROMAN, Study director, IFEMEndo - Clinique TivoliAdrien CRESTANI, Principal investigator, IFEMEndo - Clinique Tivoli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07119060
- Sponsor's protocol ID
- CliTiv-01-2025
- Other IDs
- 2024-A01400-47
- Acronym
- ATOPE
- Status last verified
- Aug 2025
- First submitted
- 23 Jul 2025
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD that underlie the results reported in this study (after de-identification) will be shared.
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.
PubMed 42049313
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Monocentric, Controlled, Randomized Trial: Comparison of Pregnancy Rates in Women With One or More Endometriomas, Treated by Cystectomy, Plasma Vaporization, or Sclerotherapy
- ClinicalTrials.gov ID
- NCT07119060
- Acronym / sponsor ID
- ATOPE / CliTiv-01-2025
- Conditions
- Endometrioma, Fertility
- Keywords
- surgery, endometrioma, endometriosis, kystectomy, sclerotherapy, plasma vaporization, fertility
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 332 participants (estimated)
- Lead sponsor
- Clinique Tivoli DucosUniversity, hospital or other
- Study start
- 18 Sep 2025 (actual)
- Primary completion
- Jul 2034 (estimated)
- Study completion
- Jan 2035 (estimated)
- First posted
- 12 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| cystectomy | Experimental | Procedure: CystectomySurgical removal of the endometrioma by gently pulling the cyst wall away from the ovarian tissue (divergent traction technique) |
| vaporization with plasma | Active comparator | Procedure: plasma vaporizationIt consists of destroying the cyst wall (vaporization) using plasma energy. |
| sclerotherapy | Other | Procedure: SclerotherapyEthanol sclerotherapy destroys the endometriotic tissue lining the inner wall of the cyst through prolonged contact with 96% ethanol. |
Who may qualify
- Ages
- 18 to 43 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CystectomySurgical removal of the endometrioma by gently pulling the cyst wall away from the ovarian tissue (divergent traction technique) | Procedure or surgery | cystectomy |
| plasma vaporizationIt consists of destroying the cyst wall (vaporization) using plasma energy | Procedure or surgery | vaporization with plasma |
| SclerotherapyEthanol sclerotherapy destroys the endometriotic tissue lining the inner wall of the cyst through prolonged contact with 96% alcohol | Procedure or surgery | sclerotherapy |
Primary outcome
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
A Pregnancy is considered if the CGH is >1000 UI/L or a intra uterine pregnancy after 5 weeks of amenorrhea
7 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Derived from this study: PubMed 42049313Crestani 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.
- Individual participant dataSharing planned: Yes. IPD that underlie the results reported in this study (after de-identification) will be shared.
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Study on the Ultrasound and Biological Characteristics of Atypical Endometriosis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Horace ROMAN study director
IFEMEndo - Clinique Tivoli
Adrien CRESTANI principal investigator
IFEMEndo - Clinique Tivoli
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cystectomy, plasma vaporization and Sclerotherapy in people with Endometrioma and Fertility, run by Clinique Tivoli Ducos at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clotilde HUET (+33 7 85 30 63 45, recherche@ifemendo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07119060, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.