Assessment of Ovarian Reserve in the Treatment of Ovarian Endometrioma With Cystectomy or Argon Plasma Coagulation: A Aandomized Clinical Trial

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 Overview

• Status: Not yet recruiting
• Conditions: Ovarian Endometrioma
• Intervention / Treatment: Procedure: Argon Plasma Coagulation (APC) ablation

• Study Type: Interventional
• Enrollment (Estimated): 146
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Diego Raimondo, MD; Phone Number: +393290636618; Email: die.raimondo@gmail.com

Study Locations

• Italy
  • Bologna
    • Bologna, Bologna, Italy, 40138
      • IRCCS Azienda Ospedaliero-Universitaria di Bologna
      • Contact: Diego Raimondo, MD; Phone Number: +393290636618; Email: die.raimondo@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Argon Plasma Coagulation (APC) ablation; Cyst opening and drainage, ablation of the inner surface of the cyst capsule using APC, and multiple biopsies of the cyst capsule.	Procedure: Argon Plasma Coagulation (APC) ablation; Cyst opening and drainage, ablation of the inner surface of the cyst capsule using APC, and multiple biopsies of the cyst capsule.
No Intervention: Cystectomy; 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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	12 months after surgery (T2).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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).	40-60 days after surgery (T1).
Temporal pattern of AFC variation	Antral follicle count (AFC) values of the ovary treated with APC and cystectomy	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	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).	40-60 days after surgery (T1)
Ultrasound recurrence rate of endometrioma	Presence/absence of an ovarian cyst with ground-glass content ≥ 10 mm	12 months after surgery (T2)
Histological appearance of the capsule of endometriomas treated with APC	Maximum depth of necrosis; persistence of endometriotic foci	40-60 days after surgery (T1), (during histological analysis of surgical specimens)

Collaborators and Investigators

• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna

Study record dates

Study Major Dates

• Study Start (Estimated): June 8, 2026
• Primary Completion (Estimated): June 8, 2028
• Study Completion (Estimated): December 8, 2029

Study Registration Dates

• First Submitted: June 19, 2026
• First Submitted That Met QC Criteria: June 19, 2026
• First Posted (Actual): June 24, 2026

Study Record Updates

• Last Update Posted (Actual): June 24, 2026
• Last Update Submitted That Met QC Criteria: June 19, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Genital Diseases, Female; Endometriosis; Therapeutics; Surgical Procedures, Operative; Ablation Techniques; Hemostatic Techniques; Electrocoagulation; Cautery; Hemostasis, Surgical; Argon Plasma Coagulation
• Other Study ID Numbers: ARG-OMA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No