Ovarian EndometriomaNCT07666412
Assessment of Ovarian Reserve in the Treatment of Ovarian Endometrioma With Cystectomy or Argon Plasma Coagulation: A Aandomized Clinical Trial
A study testing Argon Plasma Coagulation (APC) ablation in people with Ovarian Endometrioma, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
Endometriosis is a benign, chronic, and often recurrent gynecological disease affecting approximately 10% of women of reproductive age. Among the different manifestations of the disease, ovarian endometrioma represents one of the most common forms, occurring in up to 50% of affected patients. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Ovarian Endometrioma
- What is being tested?
- Argon Plasma Coagulation (APC) ablation
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteItaly
- Study dates
- 8 Jun 2026to 8 Dec 2029
- 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 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Symptomatic patients (pain and/or infertility) affected by ovarian endometriomas (unilateral or bilateral).
- Age between 18 and 40 years.
- Ultrasound diagnosis of one or more mono- or bilateral endometriotic cysts, with a maximum overall diameter (per ovary) ≤ 80 mm and at least one cyst diameter ≥ 20 mm.
- Use of hormonal therapy for at least 1 month prior to surgery.
- Willingness to undergo follow-up at 40-60 days and 12 months, according to clinical practice.
- Willingness to receive postoperative hormonal therapy, according to clinical practice, to minimize the risk of recurrence.
- Written informed consent obtained.
Who cannot join
- History of unilateral ovariectomy/adnexectomy or hysterectomy.
- Ultrasound evidence of other non-endometriotic ovarian cysts requiring surgical removal.
- Atypical endometrioma or ultrasound suspicion of malignancy.
- Previous surgery on one or both ovaries within 12 months prior to surgery.
- Known or suspected active oncological disease.
- Inability to undergo transvaginal ultrasound examination (patients with intact hymen).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, 40138
Diego Raimondo, MD, +393290636618, die.raimondo@gmail.com
About this study
Endometriosis is a benign, chronic, and often recurrent gynecological disease affecting approximately 10% of women of reproductive age. Among the different manifestations of the disease, ovarian endometrioma represents one of the most common forms, occurring in up to 50% of affected patients. Endometriomas may cause progressive damage to ovarian tissue through both mechanical effects and direct toxic effects related to the inflammatory and oxidative content of the cyst, ultimately leading to a reduction in ovarian reserve.
When medical treatment is insufficient or not indicated, surgery represents a therapeutic option. The aim of surgery is to remove the cyst while minimizing the risk of recurrence and preserving as much healthy ovarian tissue as possible. Currently, the most widely used surgical technique is laparoscopic cystectomy performed by stripping the cyst capsule. However, this procedure may result in the inadvertent removal of healthy ovarian tissue and a consequent reduction in ovarian reserve.
Read more
In recent years, ablative surgical techniques have been developed with the aim of reducing damage to the ovarian parenchyma. Among these, Argon Plasma Coagulation (APC) is a technique that uses a high-energy argon plasma jet to vaporize and coagulate superficial tissues. From a histological perspective, APC induces limited-depth tissue necrosis, generally confined to the cyst capsule, potentially reducing the risk of damage to the underlying ovarian tissue. In addition, this technology may offer practical and economic advantages.
Several studies suggest that ablative techniques may have a lower impact on ovarian reserve compared with cystectomy, as assessed by antral follicle count and serum anti-Müllerian hormone (AMH) levels, a reliable biomarker of ovarian reserve. However, the available evidence mainly derives from observational studies or studies using ablative technologies different from the one investigated in the present study. Furthermore, the systematic use of ablative techniques remains controversial in clinical practice, partly because of the potential risk of recurrence associated with residual endometriotic tissue.
To date, no randomized clinical trials have directly compared the impact of APC versus cystectomy on ovarian reserve in patients with ovarian endometrioma. Moreover, data are lacking regarding recurrence risk, post-treatment ovarian ultrasound characteristics following APC ablation, and the histological effects of this technique on endometriotic cysts.
In light of these considerations, the present randomized clinical trial aims to compare the effect of cystectomy and Argon Plasma Coagulation ablation on the preservation of ovarian reserve in patients undergoing surgical treatment for ovarian endometrioma, while also evaluating ultrasound outcomes and recurrence risk during follow-up.
- Conditions
- Ovarian Endometrioma
- Being tested
- Argon Plasma Coagulation (APC) ablation
- Medical subject headings
- Endometriosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Argon Plasma Coagulation (APC) ablationProcedure or surgery
Cyst opening and drainage, ablation of the inner surface of the cyst capsule using APC, and multiple biopsies of the cyst capsule.
| Study group | Role | What they receive |
|---|---|---|
| Argon Plasma Coagulation (APC) ablation | Experimental | Cyst opening and drainage, ablation of the inner surface of the cyst capsule using APC, and multiple biopsies of the cyst capsule. Receives: Procedure: Argon Plasma Coagulation (APC) ablation |
| Cystectomy | No intervention | Removal of the cyst capsule using the stripping technique, followed by ultra-selective hemostasis with bipolar energy and suturing of the ovarian parenchyma for hemostatic and reconstructive purposes (when indicated). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Late effects of APC or cystectomy on the AFC of the treated ovary
Change in antral follicle count (ΔAFC) of the treated ovary between baseline (T0) and 12 months (T2).
Measured: 12 months after surgery (T2).
Secondary outcomes (8)
Early effects of APC or cystectomy on the AFC of the treated ovary
Change in antral follicle count (ΔAFC) of the treated ovary between baseline (T0) and 40-60 days after surgery (T1).
Measured: 40-60 days after surgery (T1).
Late effects of APC or cystectomy on serum AMH levels
Change in serum AMH levels (ΔAMH) between baseline (T0) and 12 months (T2).
Measured: 12 months after surgery (T2).
Early effects of APC or cystectomy on serum AMH levels
Change in serum AMH levels (ΔAMH) between baseline (T0) and 40-60 days after surgery (T1).
Measured: 40-60 days after surgery (T1).
Temporal pattern of AFC variation
Antral follicle count (AFC) values of the ovary treated with APC and cystectomy
Measured: Baseline (T0), 40-60 days after surgery (T1), 12 months after surgery (T2)
Temporal pattern of AMH variation
Serum AMH levels in patients undergoing APC and cystectomy
Measured: Baseline (T0), 40-60 days after surgery (T1), 12 months after surgery (T2)
Ultrasound appearance of the ovary treated with APC
Presence/absence of an ovarian cyst; cyst volume; cyst echogenicity (isoechoic, hyperechoic, hypoechoic, ground-glass appearance).
Measured: 40-60 days after surgery (T1)
Ultrasound recurrence rate of endometrioma
Presence/absence of an ovarian cyst with ground-glass content ≥ 10 mm
Measured: 12 months after surgery (T2)
Histological appearance of the capsule of endometriomas treated with APC
Maximum depth of necrosis; persistence of endometriotic foci
Measured: 40-60 days after surgery (T1), (during histological analysis of surgical specimens)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start8 Jun 2026 (estimated)
- Primary completion8 Jun 2028 (estimated)
- Study completion8 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian EndometriomaStudies of the same condition, open and under way.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- 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
- Model description
- Ovarian reserve assessment will be performed through pre- and post-operative ultrasound evaluation of the antral follicle count (AFC), carried out by an experienced blinded sonographer. To ensure blinding, the experienced sonographer will be assisted by a second physician responsible for conducting the clinical interview with the patient, in order to provide the sonographer with the necessary clinical information while omitting any details regarding the surgical technique used. For the present study, a stratified randomization design will be adopted. Stratification will be performed according to two clinically relevant variables: patient age (cut-off: 32 years) and maximum endometrioma diameter at preoperative ultrasound assessment (cut-off: 40 mm). These factors were selected because of their potential impact on ovarian reserve and surgical outcomes.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 146 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07666412
- Sponsor's protocol ID
- ARG-OMA
- Status last verified
- Jun 2026
- First submitted
- 19 Jun 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Ovarian Reserve in the Treatment of Ovarian Endometrioma With Cystectomy or Argon Plasma Coagulation: A Aandomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07666412
- Acronym / sponsor ID
- ARG-OMA
- Conditions
- Ovarian Endometrioma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 146 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 8 Jun 2026 (estimated)
- Primary completion
- 8 Jun 2028 (estimated)
- Study completion
- 8 Dec 2029 (estimated)
- First posted
- 24 Jun 2026 (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.
Endometriosis is a benign, chronic, and often recurrent gynecological disease affecting approximately 10% of women of reproductive age. Among the different manifestations of the disease, ovarian endometrioma represents one of the most common forms, occurring in up to 50% of affected patients. Endometriomas may cause progressive damage to ovarian tissue through both mechanical effects and direct toxic effects related to the inflammatory and oxidative content of the cyst, ultimately leading to a reduction in ovarian reserve.
When medical treatment is insufficient or not indicated, surgery represents a therapeutic option. The aim of surgery is to remove the cyst while minimizing the risk of recurrence and preserving as much healthy ovarian tissue as possible. Currently, the most widely used surgical technique is laparoscopic cystectomy performed by stripping the cyst capsule. However, this procedure may result in the inadvertent removal of healthy ovarian tissue and a consequent reduction in ovarian reserve.
In recent years, ablative surgical techniques have been developed with the aim of reducing damage to the ovarian parenchyma. Among these, Argon Plasma Coagulation (APC) is a technique that uses a high-energy argon plasma jet to vaporize and coagulate superficial tissues. From a histological perspective, APC induces limited-depth tissue necrosis, generally confined to the cyst capsule, potentially reducing the risk of damage to the underlying ovarian tissue. In addition, this technology may offer practical and economic advantages.
Several studies suggest that ablative techniques may have a lower impact on ovarian reserve compared with cystectomy, as assessed by antral follicle count and serum anti-Müllerian hormone (AMH) levels, a reliable biomarker of ovarian reserve. However, the available evidence mainly derives from observational studies or studies using ablative technologies different from the one investigated in the present study. Furthermore, the systematic use of ablative techniques remains controversial in clinical practice, partly because of the potential risk of recurrence associated with residual endometriotic tissue.
To date, no randomized clinical trials have directly compared the impact of APC versus cystectomy on ovarian reserve in patients with ovarian endometrioma. Moreover, data are lacking regarding recurrence risk, post-treatment ovarian ultrasound characteristics following APC ablation, and the histological effects of this technique on endometriotic cysts.
In light of these considerations, the present randomized clinical trial aims to compare the effect of cystectomy and Argon Plasma Coagulation ablation on the preservation of ovarian reserve in patients undergoing surgical treatment for ovarian endometrioma, while also evaluating ultrasound outcomes and recurrence risk during follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Ovarian reserve assessment will be performed through pre- and post-operative ultrasound evaluation of the antral follicle count (AFC), carried out by an experienced blinded sonographer. To ensure blinding, the experienced sonographer will be assisted by a second physician responsible for conducting the clinical interview with the patient, in order to provide the sonographer with the necessary clinical information while omitting any details regarding the surgical technique used. For the present study, a stratified randomization design will be adopted. Stratification will be performed according to two clinically relevant variables: patient age (cut-off: 32 years) and maximum endometrioma diameter at preoperative ultrasound assessment (cut-off: 40 mm). These factors were selected because of their potential impact on ovarian reserve and surgical outcomes.
| Arm | Type | Receives |
|---|---|---|
| Argon Plasma Coagulation (APC) ablation | Experimental | Procedure: Argon Plasma Coagulation (APC) ablationCyst opening and drainage, ablation of the inner surface of the cyst capsule using APC, and multiple biopsies of the cyst capsule. |
| Cystectomy | No intervention | –Removal of the cyst capsule using the stripping technique, followed by ultra-selective hemostasis with bipolar energy and suturing of the ovarian parenchyma for hemostatic and reconstructive purposes (when indicated). |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Symptomatic patients (pain and/or infertility) affected by ovarian endometriomas (unilateral or bilateral).
- Age between 18 and 40 years.
- Ultrasound diagnosis of one or more mono- or bilateral endometriotic cysts, with a maximum overall diameter (per ovary) ≤ 80 mm and at least one cyst diameter ≥ 20 mm.
- Use of hormonal therapy for at least 1 month prior to surgery.
- Willingness to undergo follow-up at 40-60 days and 12 months, according to clinical practice.
Key exclusion criteria (6 listed)
- History of unilateral ovariectomy/adnexectomy or hysterectomy.
- Ultrasound evidence of other non-endometriotic ovarian cysts requiring surgical removal.
- Atypical endometrioma or ultrasound suspicion of malignancy.
- Previous surgery on one or both ovaries within 12 months prior to surgery.
- Known or suspected active oncological disease.
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 |
|---|---|---|
| Argon Plasma Coagulation (APC) ablationCyst opening and drainage, ablation of the inner surface of the cyst capsule using APC, and multiple biopsies of the cyst capsule. | Procedure or surgery | Argon Plasma Coagulation (APC) ablation |
Primary outcome
Late effects of APC or cystectomy on the AFC of the treated ovary
Time frame: 12 months after surgery (T2).
Change in antral follicle count (ΔAFC) of the treated ovary between baseline (T0) and 12 months (T2).
8 secondary outcomes
Early effects of APC or cystectomy on the AFC of the treated ovary
Time frame: 40-60 days after surgery (T1).
Late effects of APC or cystectomy on serum AMH levels
Time frame: 12 months after surgery (T2).
Early effects of APC or cystectomy on serum AMH levels
Time frame: 40-60 days after surgery (T1).
Temporal pattern of AFC variation
Time frame: Baseline (T0), 40-60 days after surgery (T1), 12 months after surgery (T2)
Temporal pattern of AMH variation
Time frame: Baseline (T0), 40-60 days after surgery (T1), 12 months after surgery (T2)
Ultrasound appearance of the ovary treated with APC
Time frame: 40-60 days after surgery (T1)
Ultrasound recurrence rate of endometrioma
Time frame: 12 months after surgery (T2)
Histological appearance of the capsule of endometriomas treated with APC
Time frame: 40-60 days after surgery (T1), (during histological analysis of surgical specimens)
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 24 Jun 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Argon Plasma Coagulation (APC) ablation in people with Ovarian Endometrioma, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
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 7 inclusion and 6 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: opening soon, as of the sponsor's last update on 24 Jun 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 Italy. 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 Diego Raimondo, MD (+393290636618, die.raimondo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Late effects of APC or cystectomy on the AFC of the treated ovary (time frame: 12 months after surgery (T2).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jun 2026.